RU2801573C1 - Wet silicone hydrogel contact lenses - Google Patents

Abstract

FIELD: ophthalmology.

SUBSTANCE: invention relates to an ophthalmic product. An ophthalmic product that comprises a sealed and autoclaved lens package containing (1) an autoclaved packaging solution containing a polymeric surfactant having an HLB value of about 11 to about 16 and a Mn of about 800 to about 20,000 dalton, and (2) an easy-to-use silicone hydrogel (SiHy) contact lens immersed in the packaging solution is provided.

EFFECT: easy-to-use SiHy contact lens contains a polymeric surfactant that provides excellent wettability of the easy-to-use SiHy contact lens immediately after opening the lens package, as well as a leachable polymeric surfactant that is physically dispersed in the polymer matrix of the SiHy contact lens and which can be released into the patient's eye for at least 7 days of daily wear; and replenish the polymeric surfactant associated with the lens surface to provide sustained wettability of the contact lens and the eye.

17 cl, 4 dwg, 8 tbl, 7 ex

Description

The present invention generally relates to silicone hydrogel contact lenses with improved and durable wettability, and to a process for making the same.

BACKGROUND OF THE INVENTION

Silicone hydrogel (SiHy) contact lenses, which are made from a hydrated cross-linked polymer material that contains silicone and a certain amount of water in the lens polymer matrix in equilibrium, are becoming increasingly popular because they have minimal adverse effects on corneal health due to their high oxygen permeability. However, the inclusion of silicone in a contact lens material can have an undesirable effect on the hydrophilicity and wettability of SiHy contact lenses because silicone is hydrophobic and tends to migrate to the lens surface upon contact with air. Contact lens manufacturers have made great efforts to develop SiHy contact lenses having a hydrophilic and wettable surface.

One class of approach to modifying the hydrophilicity and wettability of a SiHy contact lens is to subject the SiHy contact lens to a post-molding surface treatment. Examples of surface treatments after molding include plasma treatment (see, for example, commercial lenses, AIR OPTIX® from Alcon, PremiO ^TM from Menicon and PUREVISION ™ from Bausch &Lomb); covalent attachment of hydrophilic polymers to a SiHy contact lens according to various mechanisms (see, for example, US Pat. 321, 6835410, 6878399, 6923978, 6440571 and 6500481, U.S. Patent Application Publication Nos. 2009/0145086A1, 2009/0145091A1, 2008/0142038A1 and 2007/0122540A1); method of layer-by-layer (LbL) deposition of polyionic material (see, for example, US patents Nos. 8192); crosslinking LbL coatings on SiHy contact lenses (see, for example, US Pat. Nos. 8,147,897 and 8,142,835); application of a non-silicone hydrogel coating to a SiHy contact lens (see, for example, US Pat. Nos. 8,480,227; 8,529,057; 9816009, 10131815, 1022509 and 10308835; and U.S. Patent Application Publication Nos. 2019-0055427, 2019-0179055 and 2019-0309188).

One other approach is to include monomeric wetting agents (e.g., N-vinylpyrrolidone, N-vinyl-N-methylacetamide, or the like) or high molecular weight hydrophilic polymer(s) (e.g., polyvinylpyrrolidone with a Mw greater than 100,000 daltons for formation of interpenetrating networks) into a lens formulation for making a naturally wetted SiHy contact lens (i.e., SiHy wetted lenses without post-molding surface treatment) as proposed in US Pat. , 8367746 8445614 8481662 8487058 8513325 8703891 8820928 8865789 8937110 8937111 9057821 9057822 9121998 91 9140825, 9140908, 9156934, 9164298, 9170349, 9188702, 9217813, 9296159, 9322959, 9322960, 9360594 , 9529119, 6367929, 6822016, 7052131 and 7249848 and US Patent Application Publication Nos. (see, for example, 2018-0355112 and 2018-0356562). This approach can be applied to commercial SiHy contact lenses such as Biofinity® (CooperVision, Dk=128 barrer, 48% H₂O), Avaira® (CooperVision, Dk=100 barrer, 46% H₂O), Clariti® (CooperVision, Dk=60 barrer, 56% H₂O), MyDay® (CooperVision, Dk=80 barrer, 54% H₂O), ULTRA^TM (Bausch & Lomb, Dk=114 barrer, 46% H₂O), Acuvue® Oasys® (Johnson & Johnson, Dk~105 barrer, 38% H₂O); Acuvue® Advance® (Johnson & Johnson, Dk~65 barrer, 47% H₂O); Acuvue® TruEye^TM (Johnson & Johnson, Dk~100 barrer, 46% H₂O). Although this approach can be applied in the production of SiHy commercial lenses to produce new (unused) SiHy lenses with sufficiently hydrophilic surfaces, there are some limitations, such as, for example, slightly high haze due to the incompatibility of polymerizable silicone components with monomeric wetting agents and other hydrophilic components; higher silicone content on the surface; tendency to form dry spots and/or hydrophobic surface areas resulting from exposure to air, dehydration-rehydration cycles, eyelid shear forces, silicone migration to the surface and/or partial failure to prevent contact with silicone; and poor lubricity.

U.S. Patent Application No. 9,829,723 discloses improved contact lens products each comprising a plasma-coated silicone hydrogel contact lens dipped and autoclaved in a packaging solution comprising a polyoxyethylene-polyoxybutylene block copolymer and a high molecular weight copolymer of N- vinylpyrrolidone; and at least one amine-containing vinyl monomer. According to this patent, during autoclaving of a plasma-coated silicone hydrogel contact lens immersed in a buffered saline solution containing a copolymer of N-vinylpyrrolidone and an amine-containing vinyl monomer and a block copolymer of polyoxyethylene and polyoxybutylene at a relatively high concentration (for example, 400 ppm, used in Working Examples), a relatively stable film can be formed on the plasma coated silicone hydrogel contact lens to provide improved and stable wettability of the resulting plasma coated silicone hydrogel contact lens.

Thus, there is a need for an uncoated silicone hydrogel contact lens with improved and durable surface wettability suitable for continuous wear for 7 days, and a method for the efficient manufacture of such silicone hydrogel contact lenses.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides an ophthalmic product comprising a sealed and autoclavable package that includes an autoclavable packaging solution and an immersed easy-to-use silicone hydrogel contact lens, wherein the autoclavable packaging solution is buffered saline. a solution characterized by a pH of from about 6.0 to about 8.0 and contains a polymeric surfactant, where the polymeric surfactant contains at least one hydrophilic poly(oxyethylene) segment and at least one hydrophobic poly(oxybutylene) segment and is characterized by an HLB (hydrophilic-lipophilic balance) value of from about 11 to about 16 and a number average molecular weight of from about 800 to about 20,000 daltons, where an easy-to-use silicone hydrogel contact lens is obtained by placing in a package, sealing and pre-autoclaving of a molded silicone hydrogel contact lens in a packaging solution prior to autoclaving containing a polymeric surfactant, while the easy-to-use silicone hydrogel contact lens contains a polymeric surfactant physically dispersed in a polymer matrix of an easy-to-use silicone hydrogel contact lens lenses, as evidenced by the ability to release polymeric surfactant in an amount of at least 0.2 μg/lens/24 hours, as measured in an aqueous extraction process consisting of 7 extraction cycles in simulated 1-day wear, where the ability polymeric surfactant release is the amount of polymeric surfactant released per lens over 24 hours into the extraction medium that was used in the last cycle of 7 extraction cycles while simulating 1-day wear, while the easy-to-use silicone The hydrogel contact lens is further characterized by a first static water contact angle, WCA _OOP , of approximately 75 ^° or less, as measured directly after opening the sealed package by the sessile drop method, a second static water contact angle, WCA _{7_S1DW} of approximately 85 ^° or less , as measured by the sessile drop method immediately after 7 extraction cycles under simulated 1-day wear, an oxygen permeability of at least 50 barrer, a modulus of elasticity from about 0.2 MPa to about 1.5 MPa, and an equilibrium moisture content from about 38% to about 80% by weight.

In another aspect, the present invention provides a method for producing an ophthalmic product. The method of the present invention includes the steps of: a) placing and sealing a preformed silicone hydrogel contact lens in a container containing a packaging solution prior to autoclaving to form a sealed package where the preformed silicone hydrogel contact lens does not contain any coating on it and is characterized by an oxygen permeability of at least 50 barrer, an elastic modulus of from about 0.2 MPa to about 1.5 MPa and an equilibrium moisture content of from about 38% to about 80% by weight, where the packaging solution before autoclaving is a buffer a saline solution having a pH of about 6.0 to about 8.0 and includes a polymeric surfactant that contains at least one hydrophilic poly(oxyethylene) segment and at least one hydrophobic poly(oxybutylene) segment and is characterized by the value HLB from about 11 to about 16 and a number average molecular weight from about 800 to about 20,000 daltons; and b) autoclaving the sealed package containing the preformed silicone hydrogel contact lens for at least about 30 minutes to form an ophthalmic product, wherein the ophthalmic product comprises an easy-to-use silicone hydrogel contact lens in a sealed and autoclaved package. wherein the easy-to-use silicone hydrogel contact lens comprises a polymeric surfactant physically dispersed in a polymeric matrix of the easy-to-use silicone hydrogel contact lens as evidenced by the ability to release polymeric surfactant in an amount of at least 0, 2 μg/lens/24 hours, as measured in a water extraction process consisting of 7 extraction cycles in simulated 1-day wear, characterized by a first static water contact angle, WCA _OOP , of approximately 75 ^° or less, as measured immediately after opening sealed drop packaging, and a second static water contact angle, WCA _{7_S1DW} , of approximately 85 ^° or less, as measured by the sessile drop method immediately after 7 extraction cycles in simulated 1-day wear, where the polymeric surfactant release capability is is the amount of polymeric surfactant released per lens for 24 hours into the extraction medium that was used in the last cycle of 7 extraction cycles in simulated 1-day wear.

These and other aspects of the present invention will become apparent from the following description of the currently preferred embodiments. The detailed description is only illustrative of the present invention and does not limit the scope of the present invention, which is defined in accordance with the appended claims and their equivalents.

BRIEF DESCRIPTION OF GRAPHICS

In FIG. 1 schematically shows a method for measuring time to break in an aqueous film of a contact lens.

In FIG. 2 shows the general dimensions of a contact lens.

In FIG. 3A shows a fluorescent cross-sectional image of an easy-to-use SiHy lens packaged and autoclaved in a packaging solution containing a polymeric surfactant in accordance with a preferred embodiment of the present invention.

In FIG. 3B shows the results of confocal microscopy with line scanning of the cross section along the line shown in FIG. 3A.

In FIG. 4A shows a fluorescent image of a cross section of a SiHy lens packaged in the same packaging solution as in FIG. 3A, but not autoclaved.

In FIG. 4B shows the results of confocal microscopy with line scanning of the cross section along the line shown in FIG. 4A.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE PRESENT INVENTION

Unless otherwise indicated, all technical and scientific terms used in this document have the same meaning as generally understood by a person skilled in the art to which the present invention belongs. In General, the nomenclature used in this document, and laboratory procedures are well known and commonly used in the art. For these procedures, conventional methods are used, such as those presented in the prior art and various references. If a term is presented in the singular, the authors also consider the plural of that term. The nomenclature used herein and the laboratory procedures described below are well known and routinely used in the art.

In this application, the abbreviation "SiHy" means silicone hydrogel; the abbreviation "EO" means oxyethylene -C ₂ H ₄ O-; the abbreviation "BO" means oxybutylene -C ₄ H ₈ O-; the abbreviations "PEO", "PBO" and "PEO" mean poly(oxyethylene), poly(oxybutylene) and poly(oxyethylene), respectively; the abbreviation "PEG" stands for polyethylene glycol.

In the context of the present application, "approximately" means that the number referred to as "approximately" includes the specified number plus or minus 1-10% of the specified number.

The term "contact lens" refers to a structure that can be placed on the surface of the eye or inside the eye of the wearer. The contact lens may correct, enhance or change the wearer's vision, but this is not required. The contact lens may be made from any suitable material known in the art or later developed and may be a rigid lens, a rigid gas permeable lens, a soft lens, or a hybrid lens.

The term "soft contact lens" refers to a contact lens that has an elastic modulus (i.e. Young's modulus) of less than 2.5 MPa.

The term "hydrogel" or "hydrogel material" refers to a cross-linked polymeric material that is characterized by three-dimensional polymer networks (i.e., polymer matrix), is insoluble in water, but can retain at least 10 percent water by weight in its polymer matrix when fully hydrated. .

In the context of the present application, the term "silicone hydrogel" or "SiHy" refers interchangeably to a hydrogel containing silicone. Silicone hydrogel (SiHy) is typically prepared by copolymerization of a polymerizable composition comprising at least one silicone-containing vinyl monomer, or at least one silicone-containing vinyl macromer, or at least one silicone-containing prepolymer containing ethylenically unsaturated groups.

In the context of the present application, the term "non-silicone hydrogel" or "non-SiHy" refers interchangeably to a hydrogel that theoretically does not contain silicone.

Siloxane, which is often also referred to as silicone, refers to a -Si-O-Si- moiety or a molecule containing at least one -Si-O-Si- moiety, where each Si atom carries two organic groups as substituents.

In the context of the present application, the term "easy to use SiHy contact lens" refers to a fully hydrated and autoclaved SiHy contact lens that can be directly used by the patient.

In the context of this document, "hydrophilic" describes a material or part thereof that binds more readily to water than to lipids.

"Vinyl monomer" refers to a compound which is characterized by a single ethylenically unsaturated group, and is soluble in a solvent, and can be polymerized under actinic irradiation or by heating.

In the context of this application, the term "ethylenically unsaturated group" is used herein in a broad sense and is intended to cover any groups containing at least one >C=C< group. Illustrative ethylenically unsaturated groups include, without limitation, (meth)acryloyl methacryloyl , allyl, vinyl, styrenyl, or other C=C containing groups.

The term "terminal (meth)acryloyl group" refers to one (meth)acryloyl group at one of the two ends of the main chain (or main chain) of an organic compound, as known to a person skilled in the art.

The term "(meth)acrylamide" means methacrylamide and/or acrylamide.

The term "(meth)acrylate" means methacrylate and/or acrylate.

In the context of this document, "under actinic irradiation" in relation to the curing, crosslinking or polymerization of a polymerizable composition, prepolymer or material, means that the curing (e.g. crosslinking and/or polymerization) is carried out by actinic irradiation, such as, for example, UV/visible irradiation. , ionizing radiation (eg, gamma radiation or X-ray radiation), microwave radiation, and the like. Methods for thermal or actinic radiation curing are well known to those skilled in the art.

In the context of this document, "hydrophilic vinyl monomer" refers to a vinyl monomer that is usually converted as a homopolymer into a polymer that is water soluble or can absorb at least 10 percent water by weight.

"Hydrophobic vinyl monomer" in the context of this document refers to a vinyl monomer from which, as a homopolymer, a polymer is usually obtained that is insoluble in water and can absorb less than 10 percent water by weight.

"Miscible vinyl monomer" refers to a vinyl monomer capable of dissolving both the hydrophilic and hydrophobic components of the polymerizable composition to form a solution.

"Acrylic monomer" means a vinyl monomer containing only one (meth)acryloyl group.

"N-vinylamide monomer" refers to an amide compound having a vinyl group , which is directly attached to the nitrogen atom of the amide group.

"Macromer" or "prepolymer" refers to a compound or polymer that contains ethylenically unsaturated groups and has a number average molecular weight greater than 700 daltons.

In the context of this application, the term "vinyl crosslinker" refers to an organic compound containing at least two ethylenically unsaturated groups. "Vinyl crosslinker" refers to a vinyl crosslinker having a molecular weight of 700 daltons or less.

In the context of this application, the term "polymer" means a material formed by polymerization/crosslinking of one or more monomers, or macromers, or prepolymers, or combinations thereof.

In the context of this application, the term "molecular weight" of a polymeric material (including monomeric or macromeric materials) refers to the number average molecular weight, unless otherwise specifically indicated, or unless the testing conditions indicate otherwise. The person skilled in the art knows how to determine the molecular weight of a polymer according to known methods, for example, GPC (gel permeation chromatography) using one or more of a refractive index detector, a small angle laser light scattering detector, a multiangle laser light scattering detector, a differential viscometric detector, a UV detector, and infrared (IR) detector; MALDI-TOF MS (time-of-flight mass spectrometry with matrix-assisted laser desorption/ionization); spectroscopy ¹ H NMR (proton nuclear magnetic resonance), etc.

"Polysiloxane segment" refers to a polymer chain consisting of at least three successively and directly linked siloxane units (divalent radical), each of which independently of the other has the formula , wherein R ₁ ' and R ₂ ' are two substituents independently selected from the group consisting of C ₁ -C ₁₀ alkyl, C ₁ -C ₄ alkyl or C ₁ -C ₄ alkoxy-substituted phenyl, C ₁ -C ₁₀ fluoroalkyl, C ₁ -C ₁₀ fluoroether, C ₆ -C ₁₈ aryl radical, -alk-(OC ₂ H ₄ ) _γ1 -OR ^o (wherein alk is a C ₁ -C ₆ alkyl diradical, R ^o is H or C ₁ -C ₄ alkyl and γ1 is an integer from 1 to 10), a C ₂ -C ₄₀ organic radical containing at least one functional group selected from the group consisting of a hydroxyl group (-OH), a carboxyl group ( -COOH), -NR ₃ 'R ₄ ', amine bridges -NR ₃ '-, amide bridges -CONR ₃ '-, amide -CONR ₃ 'R ₄ ', urethane bonds -OCONH- and C ₁ -C ₄ alkoxy groups, or linear hydrophilic polymer chain, while R ₃ ' and R ₄ ' independently of each other represent hydrogen or C ₁ -C ₁₅ alkyl.

"Polysiloxane vinyl crosslinker" refers to a compound containing at least one polysiloxane segment and at least two ethylenically unsaturated groups.

"Linear polysiloxane vinyl crosslinker" refers to a compound containing a main chain that includes at least one polysiloxane segment and has one terminal ethylenically unsaturated group at each of the two ends of the main chain.

An "extended chain polysiloxane vinyl crosslinker" refers to a compound containing at least two ethylenically unsaturated groups and at least two polysiloxane segments, each pair of which is linked by one divalent radical.

The term "alkyl" means a monovalent radical obtained by removing a hydrogen atom from a compound based on a linear or branched alkane. An alkyl group (radical) forms one bond with one other group in an organic compound.

The term "alkylene divalent group" or "alkylene diradical" or "alkyl diradical" refers interchangeably to a divalent radical obtained by removing one hydrogen atom from an alkyl. An alkylene divalent group forms two bonds with other groups in an organic compound.

The term "alkoxy" or "alkoxy" means a monovalent radical obtained by removing a hydrogen atom from the hydroxyl group of a linear or branched alkyl alcohol. An alkoxy group (radical) forms one bond with one other group in an organic compound.

In the context of this application, the term "amino group" refers to a primary or secondary amino group of the formula -NHR', where R' represents hydrogen or an unsubstituted or substituted linear or branched C ₁ -C ₂₀ alkyl group, unless otherwise specifically indicated.

As used herein, the term "substituted" with respect to an alkyl diradical or alkyl radical means that the alkyl diradical or alkyl radical contains at least one substituent which replaces one hydrogen atom of the alkyl diradical or alkyl radical and is selected from the group consisting of hydroxyl (-OH ), carboxyl (-COOH), -NH ₂ , sulfhydryl (-SH), C ₁ -C ₄ alkyl, C ₁ -C ₄ alkoxy, C ₁ -C ₄ alkylthio (alkyl sulfide), C ₁ -C ₄ acylamino, C ₁ -C ₄ alkylamino, di-C ₁ -C ₄ alkylamino and combinations thereof.

In the context of this application, the term "phosphorylcholine" refers to a zwitterionic group , wherein n is an integer from 1 to 5, and R ₁ , R ₂ and R ₃ are independently C ₁ -C ₈ alkyl or C ₁ -C ₈ hydroxyalkyl.

The free radical initiator may be either a photoinitiator or a thermal initiator. The term "photoinitiator" refers to a chemical that initiates a free radical crosslinking/free radical polymerization reaction using light. The term "thermal initiator" refers to a chemical that initiates a radical crosslinking/radical polymerization reaction by using thermal energy.

The intrinsic "oxygen permeability", Dk _i , of a material means the rate at which oxygen will pass through the material. In the context of this application, the term "oxygen permeability (Dk)" in relation to a hydrogel (silicone or non-silicone) or a contact lens means the corrected oxygen permeability (Dk _c ), which is measured at a temperature of approximately 34-35°C and corrected for surface resistance to oxygen flow , due to the influence of the boundary layer, in accordance with the procedures described in ISO 18369-4. Oxygen permeability is usually expressed in units of barrer, where "barrer" is defined as [(cm ³ oxygen)(cm)/(cm ² )(sec.)(mm Hg)] x 10 ^-9 .

The term "oxygen transmission coefficient", Dk/t, of a lens or material means the rate at which oxygen will pass through a particular lens or material having an average thickness t [in mm units] over a measured area. The oxygen transmission coefficient is usually expressed in units of barrer/mm, where "barrer/mm" is defined as [(cm ³ oxygen)/(cm ² )(sec.)(mm Hg)] x 10 ^-9 .

"Ophthalmologically compatible" in the context of this document refers to a material or material surface that can be in direct contact with the ocular environment for an extended period of time without causing significant damage to the ocular environment and without significant discomfort to the user.

The term "modulus" or "elastic modulus" in relation to a contact lens or material means tensile modulus or Young's modulus, which is an indication of the tensile stiffness of a contact lens or material. It is well known to one skilled in the art how to determine the elastic modulus of a SiHy material or contact lens, preferably in accordance with the procedures described in Example 1.

HLB means hydrophilic-lipophilic balance (HLB) of an amphiphilic molecule, and its value is obtained by dividing the weight percentage of the hydrophilic portion by five.

In this application, the term "7 extraction cycles of simulated 1-day wear" or "7 cycles of extraction S1DW" refers interchangeably to an aqueous extraction process consisting of: (a) a 1st extraction cycle of simulated 1-day wear, which includes extraction and soaking one to three easy-to-use SiHy contact lenses from sealed packs, soaking the soaked easy-to-use SiHy contact lenses together in 1.0 ml of fresh phosphate buffered saline (PBS) (which has a pH of 7.2 ± 0.2 at 25 ^° C. and contains approximately 0.076 wt.% NaH ₂ PO ₄ ·H ₂ O, approximately 0.31 wt.% Na ₂ HPO ₄ ·2H ₂ O and approximately 0.77 wt.% NaCl) as the extraction medium in one vial for 24 hours at 35ºC with agitation, pipetting all of the PBS used in the 1st S1DW extraction cycle from the vial and analyzing the pipetted PBS used in the 1st S1DW extraction cycle; and (b) S1DW extraction cycles 2 through 7, each of which includes the addition of 1.0 ml of fresh PBS as extraction medium to a vial containing easy-to-use SiHy contact lenses that have been subjected to a previous S1DW extraction cycle, soaking easy-to-use SiHy contact lenses in added 1 ml of fresh PBS as extraction medium for 24 hours at 35ºC with stirring, pipetting all of the PBS used in the current S1DW extraction cycle from the vial, and analyzing the pipetted PBS used in the current extraction cycle S1DW. Each extraction medium used in each of the 7 S1DW extraction cycles can be analyzed by any method known to one of skill in the art, preferably by the UPLC method.

According to the present invention, the step of soaking one easy-to-use SiHy contact lens in 1.0 ml of fresh PBS at 35 ^° C. for 24 hours is intended to simulate the patient wearing an easy-to-use SiHy lens on the eye for one day (8 to 24 hours) . It should be noted that the volume of fresh PBS in each cycle is chosen to be comparable to the normal average production of tear fluid from the eye per day. Schirmer, in his classic study of lacrimal secretion in 1903, estimated that the amount of tears produced in 16 hours of wakefulness under normal conditions is from 0.5 to 0.75 g (Schirmer, O. Graefes Arhiv für Ophthalmologie 1903, 56: 197 -291).

It is understood that the number of easy-to-use SiHy contact lenses to be used in studies using 7 extraction cycles with simulated 1-day wear depends on the limit of detection of the chosen analytical method (e.g., UPLC) and the amount of polymeric surfactant leached onto one lens per 24 hours. More easy-to-use SiHy contact lenses can be used in studies using 7 extraction cycles with simulated 1-day wear to improve the accuracy and reliability of the tests, as known to a person skilled in the art.

"UV-A" refers to radiation observed in the wavelength range from 315 to 380 nm; "UV-B" refers to radiation in the range of 280 to 315 nm; "violet" refers to radiation occurring in the wavelength range from 380 to 440 nm.

"UV-A Transmittance" (or "%T UV-A"), "UV-B Transmittance" or "%T UV-B" and "Violet Transmittance" or "Violet %T" are calculated as follows: formula.

The term "naturally wettable" or "naturally wettable" in relation to SiHy contact lenses interchangeably means that SiHy has a water film break time (WBUT) of approximately 5 seconds or more and a water contact angle (WCA _s ) measured according to static sessile drop method of about 90 degrees or less without any surface treatment after forming the SiHy contact lens by thermal or actinic polymerization (i.e., curing) of the SiHy lens composition. According to the present invention, WBUT and _WCAs are measured according to the procedures described in Example 1.

"Coating" in relation to a contact lens means that the contact lens has on its surfaces a thin layer of material that is different from the base material of the contact lens and obtained by subjecting the contact lens to a surface treatment.

In the context of this document, "surface modification" or "surface treatment" means that an article has been processed in a surface treatment process in which (1) a coating is applied to the surface of the article, (2) chemicals are adsorbed to the surface of the article, (3) the chemical the nature (eg, electrostatic charge) of the chemical groups on the surface of the article; or (4) the surface properties of the article are otherwise altered. Typical surface treatment processes include, but are not limited to, surface treatment by energy treatment (e.g., plasma, static electric charge, irradiation, or other energy source), chemical treatments, grafting of hydrophilic vinyl monomers or macromers onto the surface of an article, in-mold transfer method, disclosed in US Pat. No. 6,719,929, the incorporation of wetting agents into a contact lens formulation as proposed in US Pat. Nos. 6,367,929 and 6,822,016; physically depositing one or more layers of one or more hydrophilic polymers on the surface of a contact lens as disclosed in US Patent Nos. 8,147,897 and 8,409,599 and US Patent Application Publication Nos. 2011/0134387, 2012/0026457 and 2013/0118127.

"Post-curing surface treatment" in relation to a SiHy contact lens means a surface treatment process that is performed after the SiHy contact lens is molded by curing (i.e., thermal or actinic polymerization) of the SiHy lens composition. "SiHy lens formulation" refers to a polymerizable composition that contains all of the necessary polymerizable components to form a SiHy contact lens or bulk SiHy lens material, as is well known to those skilled in the art.

The present invention relates generally to an ophthalmic product that comprises a sealed and autoclaved lens package comprising a packaging solution and an easy-to-use SiHy contact lens immersed in the packaging solution. The packaging solution contains a polymeric surfactant having an HLB value of about 11 to about 16 and a number average molecular weight of about 800 to about 20,000 daltons. The easy-to-use SiHy contact lens contains a polymeric surfactant (i.e., a surface-bound or surface-adsorbed polymeric surfactant) that provides excellent wettability of the easy-to-use SiHy contact lens immediately after opening the lens package. It is believed that at least a significant portion of the polymeric surfactant adsorbed on the surface of the lens may be released into the lacrimal fluid shortly after administration to the eye. Given that the normal average tear fluid volume is 6.2 ± 2.0 µl (S. Mishima et al., Invest. Ophthalmol. Vis. Sci. 1966, 5: 264-276), the concentration of polymeric surfactant in the tear liquid can be very high shortly after the lens is inserted into the eye, which ensures good wetting of the eye. The easy-to-use SiHy contact lens also contains a leachable polymeric surfactant that is physically taken up (absorbed) by the SiHy contact lens during autoclaving and physically distributed in the SiHy polymer matrix of the contact lens. The polymeric surfactant physically absorbed and distributed in an easy-to-use SiHy contact lens can be released into the patient's eye for at least 7 days of daily wear and replenish the polymeric surfactant bound to the lens surface, thereby providing stable wettability. contact lenses and eyes. An easy-to-use SiHy contact lens with these two features can provide a wearer with at least one week of wearing comfort. Thus, the SiHy contact lenses of the present invention are suitable for use as weekly replacement contact lenses.

The present invention is based in part on the surprising discovery that SiHy contact lenses, which have a relatively high equilibrium moisture content (at least 38%, preferably at least 40%), a relatively low modulus of elasticity (for example, below 1.5 MPa) and relatively high oxygen permeability (e.g., at least 50 barrer) and do not contain any coating on them, it is possible to achieve the two required characteristics described above simply by packaging and autoclaving a SiHy contact lens in a lens package containing a polymeric surfactant a substance that is composed of at least one hydrophilic poly(oxyethylene) segment and at least one hydrophobic poly(oxybutylene) segment and has an HLB value of from about 11 to about 16 and a number average molecular weight of from about 800 to about 20,000 daltons, and which is present in the lens packaging solution in an amount low enough not to significantly increase lens diameters, but still sufficient to give SiHy contact lenses the two desired characteristics.

It is believed that if a SiHy contact lens has an oxygen permeability of at least 50 barre, it may have hydrophobic (ie silicone) regions mixed with hydrophilic regions on a microscopic scale. The number of such microscopic hydrophobic patches may be large enough to dissolve a significant amount of polymeric surfactant having an HLB value of from about 11 to about 16.

It is also believed that if a SiHy contact lens has a modulus of elasticity from about 0.2 MPa to about 1.5 MPa and an equilibrium moisture content from about 38% to about 80% by weight, it may have pores with a size large enough to penetrate a sufficient amount a polymeric surfactant having a number average molecular weight of from about 800 to about 20,000 daltons, inside the SiHy contact lens during autoclaving and storage, and for subsequent leaching from the SiHy contact lens when worn on the eye.

It is also believed that the unique amphiphilic nature of the polymeric surfactant of the present invention allows it to be physically attached to the surface of the SiHy contact lens described above and physically distributed in the polymer matrix of the SiHy contact lens described above. The hydrophobic poly(oxybutylene) polymeric surfactant segment(s) may have hydrophobic interactions with silicone inclusions on the lens surface and silicones just below the surface and with microscopic hydrophobic regions within the SiHy contact lens. Such hydrophobic-hydrophobic interactions provide the driving forces for physical bonding on the lens surface (to form a surface layer) and penetration of the polymeric surfactant into the lens. It is also believed that the polymeric surfactant should be located at the interface between the microscopic hydrophobic and hydrophilic regions to minimize surface energy due to its amphiphilic nature, thereby reducing the rate of migration of the polymeric surfactant from within the SiHy contact lens into the ocular environment during wearing.

Typically, contact lenses that are hydrated and packaged in a packaging solution must be sterilized before being given to patients. Sterilization of hydrated lenses during manufacture and packaging is typically accomplished by autoclaving. The autoclaving process includes heating a contact lens package to a temperature of about 118°C to about 125°C for about 20-50 minutes under pressure. It has been found that during autoclaving, such a polymeric surfactant present in the packaging solution can not only physically attach to the surface of the SiHy contact lens, but also can penetrate deeply into the SiHy contact lens to be distributed in the SiHy polymer matrix of the contact lens. The penetration efficiency of the polymeric surfactant into the SiHy contact lens described above during autoclaving can be high enough to reduce the concentration of polymeric surfactant in the lens packaging solution while maintaining a sufficient amount of leachable polymeric surfactant that may be released into the patient's eye for at least 7 days of daily wear to provide consistent wettability of the contact lens.

It is known that hydrophobic interactions (forces) are highly dependent on temperature, with the higher the temperature, the stronger the hydrophobic-hydrophobic interactions and the stronger the driving force for the penetration (diffusion) of the polymeric surfactant into the SiHy contact lens. It is believed that during autoclaving, the penetration of the polymeric surfactant present in the packaging solution into the SiHy contact lens will be greatly accelerated, so that a significant amount of the polymeric surfactant can be incorporated into the SiHy contact lens.

It should be noted that while the autoclaving process may accelerate the penetration of the polymeric surfactant, it may not be sufficient to achieve an equilibrium in terms of the distribution of the polymeric surfactant between the packaging solution and the silicone hydrogel contact lens. During storage at room temperature of sealed and autoclaved lens packages with easy-to-use SiHy contact lenses, the amount of polymeric surfactant absorbed by the silicone hydrogel contact lens is likely to increase over time until equilibrium is reached. This slow uptake process after autoclaving the polymeric surfactant into the silicone hydrogel contact lens immersed in the packaging solution in the sealed lens package ensures that more of the polymeric surfactant is absorbed by the silicone hydrogel contact lens, and subsequently more the amount of polymeric surfactant will be released when worn on the eye.

It should also be noted that the SiHy contact lens of the present invention cannot be prepared from a SiHy lens composition comprising a polymeric surfactant having a number average molecular weight of from about 800 to about 20,000 Daltons, since it is highly likely that the polymeric surfactant will removed from SiHy-derived contact lenses during the lens extraction and hydration processes required to make SiHy contact lenses.

Using the method of the present invention, the adsorption of the polymeric surfactant on the surface of the lens and the incorporation of the polymeric surfactant into the lens can be combined with a sterilization (autoclaving) step in the manufacture of SiHy contact lenses. The resulting contact lenses may not only have a combination of desirable contact lens properties including relatively high oxygen permeability, relatively high water content, relatively low modulus and good surface wettability, but also the two features described above.

In one aspect, the present invention provides an ophthalmic product comprising a sealed and autoclavable package that includes an autoclavable packaging solution and an immersed easy-to-use silicone hydrogel contact lens, wherein the autoclavable packaging solution is buffered saline. a solution having a pH of from about 6.0 to about 8.0 (preferably from about 6.5 to about 7.5) and includes a polymeric surfactant that contains at least one hydrophilic poly(oxyethylene) segment and at least one hydrophobic poly(oxybutylene) segment and has an HLB value of from about 11 to about 16 and a number average molecular weight of from about 800 to about 20,000 Daltons (preferably from about 800 to about 10,000 Daltons, more preferably from about 1000 to about 8000 Daltons) where an easy-to-use silicone hydrogel contact lens is obtained by placing in a package, sealing and autoclaving a preformed silicone hydrogel contact lens in a packaging solution prior to autoclaving containing a polymeric surfactant, where the preformed silicone hydrogel contact lens the lens does not contain any coating on it, while the easy-to-use silicone hydrogel contact lens contains a polymeric surfactant physically dispersed in the polymer matrix of the easy-to-use silicone hydrogel contact lens, as evidenced by the ability to release the polymeric surfactant substance in an amount of at least 0.2 µg/lens/24 hours (preferably at least 0.4 µg/lens/24 hours, more preferably at least 0.6 µg/lens/24 hours, even more preferably at least 0.8 μg/lens/24 hours, most preferably at least 1.0 μg/lens/24 hours) as measured in an aqueous extraction process consisting of 7 extraction cycles under simulated 1-day wear, where the ability polymeric surfactant release is the amount of polymeric surfactant released per lens over 24 hours into the extraction medium that was used in the last cycle of 7 extraction cycles while simulating 1-day wear, while the easy-to-use silicone The hydrogel contact lens is further characterized by a first static water contact angle, WCA _OOP , of about 75 ^° or less (preferably about 70 ^° or less, more preferably about 65 ^° or less, even more preferably about 60 ^° or less), as measured immediately after opening the sealed package using the sessile drop method, a second static water contact angle, WCA _{7_S1DW} , of about 85 ^° or less (preferably about 80 ^° or less, more preferably 75 ^° or less, even more preferably 70 ^° or less), as measured by sessile drop immediately after 7 extraction cycles under simulated 1-day wear, oxygen permeability of at least 50 barrer, modulus of elasticity from about 0.2 MPa to about 1.5 MPa, and equilibrium moisture content from about 38% to about 80% by weight.

In another aspect, the present invention provides a method for producing an ophthalmic product. The method of the present invention includes the steps of: a) placing and sealing a preformed silicone hydrogel contact lens in a container containing a packaging solution prior to autoclaving, where the preformed silicone hydrogel contact lens does not contain any coating on it and is oxygen permeable, of at least 50 barrer, an elastic modulus of from about 0.2 MPa to about 1.5 MPa, and an equilibrium moisture content of from about 38% to about 80% by weight, wherein the packaging solution prior to autoclaving is a buffered saline solution having pH from about 6.0 to about 8.0 (preferably from about 6.5 to about 7.5), and includes a polymeric surfactant that contains at least one hydrophilic poly(oxyethylene) segment and at least one hydrophobic a poly(oxybutylene) segment and is characterized by an HLB value of from about 11 to about 16 and a number average molecular weight of from about 800 to about 20,000 Daltons (preferably from about 800 to about 10,000 Daltons, more preferably from about 1000 to about 8000 Daltons); and b) autoclaving the sealed package containing the preformed silicone hydrogel contact lens for at least about 30 minutes to form an ophthalmic product, wherein the ophthalmic product comprises an easy-to-use silicone hydrogel contact lens in a sealed and autoclaved package wherein the easy-to-use silicone hydrogel contact lens comprises a polymeric surfactant physically dispersed in a polymeric matrix of the easy-to-use silicone hydrogel contact lens, as evidenced by the ability to release polymeric surfactant in an amount of at least 0 .2 µg/lens/24 hours (preferably at least 0.4 µg/lens/24 hours, more preferably at least 0.6 µg/lens/24 hours, even more preferably at least 0.8 µg/lens /24 hours, most preferably at least 1.0 μg/lens/24 hours), as measured in a water extraction process consisting of 7 extraction cycles in simulated 1-day wear, characterized by a first static water contact angle, WCA _OOP , of about 75 ^° or less (preferably about 70 ^° or less, more preferably about 65 ^° or less, even more preferably about 60 ^° or less) as measured immediately after opening the sealed package by the sessile drop method, and the second static water contact angle , WCA _{7_S1DW} of about 85 ^° or less (preferably about 80 ^° or less, more preferably 75 ^° or less, even more preferably 70 ^° or less) as measured by the sessile drop method immediately after 7 extraction cycles in simulated 1-day wear where polymeric surfactant releasing capacity is the amount of polymeric surfactant released per lens over 24 hours into the extraction medium that was used in the last cycle of 7 extraction cycles in simulated 1-day wear.

According to the present invention, the first static water contact angle, WCA _OOP , of an easy-to-use SiHy contact lens is determined by the polymeric surfactant that has been adsorbed on the surface of the easy-to-use SiHy contact lens and that has been absorbed in the area immediately below the lens surface during processing. in the autoclave, while the second static water contact angle, WCA _{7_S1DW} , of the easy-to-handle SiHy contact lens is determined by the polymeric surfactant that has been physically absorbed and distributed in the polymer matrix of the easy-to-handle SiHy contact lens during autoclaving and which migrated from deep within the lens to the superficial area just below the lens surface and onto the lens surface during the last cycle of 7 extraction cycles in simulated 1-day wear.

A person skilled in the art will be aware of lens packages (or containers) suitable for autoclaving and storage of contact lenses. Any lens packaging can be used in the present invention. Preferably, the lens package is a blister pack that includes a base and a lid, in which the lid is releasably sealed to the base, in which the base contains a cavity to receive a sterile packaging solution and a contact lens.

The lenses are individually packaged, sealed, and autoclaved (eg, autoclaved at about 120° C. or higher for about 30 minutes to about 45 minutes under pressure) prior to distribution to users. One skilled in the art will readily understand how to seal and autoclave lens packages.

According to the present invention, the packaging solution before or after autoclaving is ophthalmologically compatible and is any aqueous solution that is used to store contact lenses known to the person skilled in the art.

The packaging solution before or after autoclaving according to the present invention is a buffered saline solution.

In this application, the term "buffered saline solution" refers to an aqueous solution that contains from about 0.15% to 0.95% by weight of one or more salts (for example, sodium chloride, potassium chloride, or any ophthalmologically compatible salts known to a person skilled in the art field) and one or more buffer substances to maintain the pH of the salt solution.

The packaging solution before or after autoclaving contains one or more buffering agents to maintain the pH of the packaging solution in a physiologically acceptable range of about 6 to about 8 (preferably about 6.5 to about 7.5). Any known physiologically compatible buffer substances may be used. Suitable buffer substances as a constituent of the contact lens care composition of the present invention are known to the person skilled in the art. Examples are boric acid, borates, eg sodium borate, citric acid, citrates, eg potassium citrate, bicarbonates, eg sodium bicarbonate, TRIS (2-amino-2-hydroxymethyl-1,3-propanediol), Bis-Tris ( bis(2-hydroxyethyl)iminotris(hydroxymethyl)methane), bis-aminopolyols, triethanolamine, ACES (N-(2-hydroxyethyl)-2-aminoethanesulfonic acid), BES (N,N-bis(2-hydroxyethyl)-2- aminoethanesulfonic acid), HEPES (4-(2-hydroxyethyl)-1-piperazineethanesulfonic acid), MES (2-(N-morpholino)ethanesulfonic acid), MOPS (3-[N-morpholino]propanesulfonic acid), PIPES (piperazine- N, N'-bis(2-ethanesulfonic acid)), TES (N-[tris(hydroxymethyl)methyl]-2-aminoethanesulfonic acid), their salts, phosphate buffers (for example, Na ₂ HPO ₄ , NaH ₂ PO ₄ and KH ₂ PO ₄ ) or mixtures thereof. Preferred buffering agents are borate buffers and phosphate buffers. The amount of each buffer is such as is necessary to effectively achieve a pH of the composition of about 6.5 to about 7.5. It is usually present in an amount of 0.001% to 2%, preferably 0.01% to 1%; most preferably from about 0.05% to about 0.30% by weight.

According to the present invention, the packaging solutions before and after autoclaving contain a polymeric surfactant, which should include at least one poly(oxyethylene) segment as a hydrophilic component and a poly(oxybutylene) segment as a hydrophobic component. This may be a diblock copolymer referred to as PEO-PBO, a triblock copolymer referred to as PEO-PBO-PEO or PBO-PEO-PBO, or other block type configurations. Unless expressly stated otherwise, all references to "PEO-PBO block copolymers" in this document include all of the above forms. These copolymers can also be described in terms of an approximate or average value assigned to the respective repeating group. For example, R-(EO) ₂₀ (BO) ₅ -H, where the average value of the oxyethylene (EO) group is 20 and the average value of the oxybutylene (BO) group is 5.

Preferred polymeric surfactants of the present invention are diblock copolymers of the following general formula:

R-(EO) _m (BO) _n -H (S1),

where R is selected from the group consisting of hydrogen, methyl, ethyl, propyl and butyl; m is an integer having an average value of 10 to 250; and n is an integer having an average value of 5 to 125, with the proviso that m/n is from about 2:1 to about 10:1, preferably from about 3:1 to about 6:1.

Particularly preferred are PEO-PBO diblock copolymers of the following general formula:

(S2)

where R is selected from the group consisting of hydrogen, methyl, ethyl, propyl and butyl; m is an integer having an average value of 10 to 250; and n is an integer having an average value of 5 to 125, with the proviso that m/n is from about 2:1 to about 10:1, preferably from about 3:1 to about 6:1.

Most preferred is a copolymer of formula (S2) wherein R is methyl; m is characterized by an average value of 45; and n has a mean value of 10.

The PEO-PBO block copolymers used in the present invention have a molecular weight in the range of 800 to about 10,000 daltons, and more preferably in the range of 1,000 to about 8,000 daltons.

According to the present invention, the number average molecular weight of the polymeric surfactant is determined from ¹ H NMR spectroscopy data. The use of ¹ H NMR spectroscopy to determine the molecular weight of polymers is described in publications such as JU Izunobi & CL Higginbotham, J. Chem. Edu. 2011, 88: 1098-1104; S C. Shit and S. Maiti, Eur. Polym. J. 1986, 22: 1001-1008; KJ Liu, Makromol. Chem. 1968, 116: 146-151; FW Yeager & JW Becker Chem. 1977, 49: 722-724; EG Brame, RC Ferguson, GJ Thomas, Anal. Chem. 1967, 39: 517-521; TF Page & W.E. Bresler, Anal. Chem. 1964, 36: 1981-1985; T. Cosgrove et al., Langmuir 2015, 31: 8469-8477; GB Shah, exPRESS Paulm. Lett. 2008, 2: 829-834; KJ Liu, Macromecules, 1968, 1: 213-217; K. Paulsen & D. Frasco, ThermoFisher Application Note Pub. no. AN52907_E_11/16M (2016).

The PEO-PBO block copolymers described above can be synthesized according to the procedures described in US Pat. No. 8,318,144 (incorporated herein by reference in its entirety).

It has been found that if the concentration of polymeric surfactant in the packaging solution prior to autoclaving is too high, an easy-to-use SiHy contact lens may have a significantly altered lens diameter due to penetration of a significant amount of polymeric surfactant into the lens. According to the present invention, the amount of polymeric surfactant in the packaging solution prior to autoclaving is chosen to provide a difference in lens diameter between an easy-to-use SiHy contact lens autoclaved in a packaging solution containing a polymeric surfactant according to the present invention and a control a lens that is a SiHy preformed contact lens autoclaved in PBS containing no polymeric surfactant of less than about 0.20 mm (preferably about 0.17 mm, more preferably about 0, 14 mm, even more preferably about 0.11 mm) and that the easy-to-use SiHy contact lens contains at least about 25 µg/lens (preferably at least about 30 µg/lens, more preferably at least about 35 µg/lens). lens, even more preferably at least about 40 µg/lens, most preferably at least about 50 or 60 or 70 or 80 or 90 µg/lens) polymeric surfactant.

In a preferred embodiment, the amount of polymeric surfactant in the packaging solution prior to autoclaving is from about 0.005% to about 0.038% by weight (preferably from about 0.007% to about 0.036% by weight, more preferably from about 0.008% to 0.034% by weight, even more preferably from about 0.009% to 0.032% by weight, most preferably from about 0.010% to 0.030% by weight).

According to the present invention, the amount of polymeric surfactant in an easy-to-use SiHy contact lens is an average value obtained by averaging the amounts of polymeric surfactant in 5 easy-to-use SiHy contact lenses. The amount of polymeric surfactant in each easy-to-use SiHy contact lens is determined first by fully extracting the polymeric surfactant from the easy-to-use SiHy contact lens with an extraction medium (e.g., acetone/hexane 1:1) and then determining the amount of polymeric surfactant in the extraction medium.

It is also understood that the duration of autoclaving can also affect the amount of polymeric surfactant absorbed by the easy-to-use SiHy contact lens. The longer the autoclaving time, the greater the amount of polymeric surfactant absorbed by the easy-to-use SiHy contact lens.

The packaging solutions prior to autoclaving according to the present invention are preferably formulated to be isotonic with the lacrimal fluid. A solution that is isotonic with lacrimal fluid is usually understood as a solution whose concentration corresponds to that of 0.9% sodium chloride solution (308 mOsm/kg). Deviations from this concentration are possible everywhere.

The isotonicity of the lacrimal fluid, or even other desired tonicity, can be adjusted by adding organic or inorganic substances that affect the tonicity. Suitable ophthalmic tonicity agents include, but are not limited to, sodium chloride, potassium chloride, glycerin, propylene glycol, polyols, mannitols, sorbitol, xylitol, and mixtures thereof. Preferably, most of the tonicity of the solution is provided by one or more compounds selected from the group consisting of halide-free electrolytes (eg sodium bicarbonate) and non-electrolyte compounds. The tonicity of the solution is typically adjusted to be in the range of about 200 to about 450 milliosmoles (mOsm), preferably about 250 to 350 mOsm.

In a preferred embodiment, the packaging solution prior to autoclaving contains from about 0.1% to about 2% by weight of a high molecular weight hydrophilic polymer (i.e. having a number average molecular weight of at least 100,000 daltons, preferably at least 200,000 daltons). The high molecular weight hydrophilic polymer is preferably polyvinylpyrrolidone, or more preferably a copolymer of N-vinylpyrrolidone and at least one amine-containing vinyl monomer, wherein the amine-containing vinyl monomer is selected from the group consisting of an alkylaminoalkyl methacrylate having 8 to 15 carbon atoms, an alkylaminoalkyl acrylate having 7- 15 carbon atoms, dialkylaminoalkyl methacrylate containing 8-20 carbon atoms, dialkylaminoalkyl acrylate containing 7-20 carbon atoms, and N-vinylalkylamide containing 3-10 carbon atoms.

According to the present invention, the number average molecular weight of the high molecular weight hydrophilic polymer is determined by the GPC/RI (Refractive Index)/LS (Light Scattering) method under the following conditions.

Speakers: set of 2 columns Waters Ultra-Hydrogel Linear 300X7.8 mm Mobile phase: 0.2 M sodium nitrate and 0.02% (w/w) sodium azide (aqueous) for multi-angle laser light scattering (MALLS) Temperature: 25°C MALLS detector: Waters Alliance e-2695 with RI/LS (Wyatt DAWN) Consumption: 0.5 ml/min. (nominal) Sample volume: 0.100 ml Standards: poly(ethylene glycol), poly(ethylene oxide), poly(acrylamide) from American Polymer Standard Corporation; poly(saccharide) from Polymer Laboratories Sample preparation: 90°C for 30 min. in an aqueous mobile phase previously filtered through a 0.45 µm syringe filter (HT Tuffryn, PALL, PN 4497T membrane) into autosampler vials

Examples of amine-containing vinyl monomers include, without limitation, alkylaminoalkyl methacrylate having 8-15 carbon atoms, alkylaminoalkyl acrylate having 7-15 carbon atoms, dialkylaminoalkyl methacrylate having 8-20 carbon atoms, dialkylaminoalkyl acrylate having 7-20 carbon atoms, N-vinylalkylamide having 3- 10 carbon atoms. Examples of preferred N-vinylalkylamide include, but are not limited to, N-vinylformamide, N-vinylacetamide, N-vinylisopropylamide, and N-vinyl-N-methylacetamide.

Examples of preferred copolymers include, but are not limited to, copolymers of N-vinylpyrrolidone and dimethylaminoethyl methacrylate. Such preferred copolymers are commercially available, such as copolymer 845 and copolymer 937 from ISP.

It is believed that in the packaging solution prior to autoclaving for packaging and autoclaving a preformed SiHy contact lens not containing any coating, the high molecular weight hydrophilic polymer can be synergistic with the polymeric surfactant to reduce the static contact angle with water of an easy-to-use SiHy contact lens (i.e., with increased wettability of an easy-to-use SiHy contact lens). It is also believed that a high molecular weight hydrophilic polymer, in particular polyvinylpyrrolidone, or more preferably a copolymer of N-vinylpyrrolidone and at least one amine-containing vinyl monomer, can complex with a polymeric surfactant at or near the surface of a silicone hydrogel contact lens, acting as a carrier for the polymeric surfactant and thereby enhancing the absorption of the polymeric surfactant into the polymer matrix of the silicone hydrogel contact lens.

The packaging solution prior to autoclaving of the present invention may optionally include viscosity-increasing polymers, which may be a water-soluble polymer derived from cellulose, water-soluble polyvinyl alcohol (PVA), or a combination thereof. Examples of suitable polymers derived from cellulose include, without limitation, cellulose ethers. Exemplary preferred cellulose ethers are methylcellulose (MC), ethylcellulose, hydroxymethylcellulose, hydroxyethylcellulose (HEC), hydroxypropylcellulose (HPC), hydroxypropylmethylcellulose (HPMC), or a mixture thereof. More preferably, the cellulose ether is hydroxyethylcellulose (HEC), hydroxypropyl methylcellulose (HPMC), and mixtures thereof. Cellulose ether is present in the composition in an amount preferably from about 0.1% to about 1% by weight, based on the total amount of the packaging solution.

According to the present invention, the packaging solution prior to autoclaving may additionally contain mucin-like substances, ophthalmologically friendly substances and/or additional surfactants.

Illustrative mucin-like substances include, without limitation, polyglycolic acid and polylactides.

Illustrative ophthalmologically beneficial substances include, but are not limited to, 2-pyrrolidone-5-carboxylic acid (PCA), amino acids (e.g., taurine, glycine, etc.), alpha-hydroxy acids (e.g., glycolic, lactic, malic, tartaric, mandelic, and citric acids and their salts, etc.), linoleic and gamma-linolenic acids and vitamins (eg B5, A, B6, etc.).

Examples of preferred surfactants as co-surfactants include, but are not limited to, poloxamers (e.g., Pluronic® F108, F88, F68, F68LF, F127, F87, F77, P85, P75, P104, and P84), poloxamines (e.g., Tetronic ® 707, 1107 and 1307), polyethylene glycol esters of fatty acids (for example, Tween® 20, Tween® 80), polyoxyethylene or polyoxypropylene esters of C ₁₂ -C ₁₈ alkanes (for example, Brij® 35), polyoxyethylene stearate (Myrj® 52), polyoxyethylene propylene glycol stearate (Atlas® G 2612); and amphoteric surfactants under the tradenames Mirataine® and Miranol®.

In accordance with all the various aspects of the present invention, the preformed SiHy contact lens of the present invention may be any SiHy contact lens that has not been subjected to any surface treatment to form a coating thereon after manufacture in accordance with any lens manufacturing processes. The person skilled in the art is very well aware of how to make SiHy contact lenses. For example, SiHy contact lenses can be made in a conventional "rotation mold" as described in, for example, US3408429, or by a full static mold injection molding process as described in US Pat. Nos. 4,347,198; 5508317; 5583163; 5789464; and 5849810, or a turning undercut from polymer blanks used in the manufacture of contact lenses to order. In injection molding, the polymerizable composition (ie, SiHy lens formulation) is typically poured into molds and cured (ie, polymerized and/or crosslinked) in molds to make SiHy contact lenses.

Lens molds for the manufacture of contact lenses, including SiHy contact lenses, are well known to those skilled in the art and are, for example, used in injection molding or spin casting. For example, a mold (for injection molding) generally includes at least two mold doors (or parts) or mold halves, ie a first and a second mold halves. The first mold half defines the first forming (or optical) surface, and the second mold half defines the second forming (or optical) surface. The first and second halves of the mold are made with the possibility of alignment with each other so that between the said first forming surface and the second forming surface a cavity for forming a lens is formed. The forming surface of the mold half is the cavity-forming surface of the mold and is in direct contact with the polymerizable composition.

Methods for making mold flaps for injection molding a contact lens are generally well known to those skilled in the art. The method of the present invention is not limited to any particular mold making method. In fact, any method of making a mold can be used in the present invention. The first and second mold halves can be made using various techniques such as injection molding or turning. Examples of suitable processes for forming mold halves are disclosed in US Pat. Nos. 4,444,711; 4,460,534;

Virtually all materials known in the art of mold making can be used to create molds for contact lenses. For example, polymeric materials such as polyethylene, polypropylene, polystyrene, PMMA, ^Topas® COC class 8007-S10 (clear amorphous ethylene-norbornene copolymer, from Ticona GmbH, Frankfurt, Germany, and Summit, NJ) or the like can be used. n. Other UV-transmitting materials such as quartz glass and sapphire can be used.

In a preferred embodiment, reusable molds are used and the lens-forming composition is cured by actinic irradiation while spatially limiting the actinic irradiation to form a contact lens. Examples of preferred reusable molds are those disclosed in US Pat. Nos. 6,627,124, _6,800,225 , 7,384,590, and 7,387,759 ^. transparent amorphous ethylene-norbornene copolymer) from Ticona GmbH, Frankfurt, Germany, and Summit, NJ, Zeonex® and Zeonor® from Zeon Chemicals LP, Louisville, KY), polymethyl methacrylate (PMMA), polyoxymethylene from DuPont (Delrin), Ultem ® (polyetherimide) from GE Plastics, PrimoSpire®, etc.

According to the present invention, the polymerizable composition can be introduced (filled) into the cavity formed by the form, in accordance with any known methods.

After the polymerizable composition is poured into a mold, it is polymerized to form a SiHy contact lens. Crosslinking can be initiated by thermal or actinic action, preferably by exposing the polymerizable composition in the form of spatially limited actinic radiation to crosslink the polymerizable components in the polymerizable composition.

Opening the mold for removing the molded SiHy contact lens from the mold can be carried out in a known manner. way.

The molded SiHy contact lens is subjected to lens extraction to remove non-polymerized polymerizable components and then lens hydration. The extracting solvent may be any solvent known to the person skilled in the art. Examples of a suitable extraction solvent are described below.

The preformed SiHy contact lenses may be any commercially available SiHy contact lenses or may be manufactured according to any known methods. For example, for the preparation of preformed SiHy contact lenses, a SiHy lens composition for injection molding or centrifugal casting, or for the manufacture of SiHy rods used in the turning of contact lenses, typically contains at least one component selected from the group consisting of a silicone-containing vinyl monomer, a polysiloxane-vinyl crosslinker, a silicone-containing prepolymer, a hydrophilic vinyl monomer, a hydrophobic vinyl monomer, a crosslinker other than siloxane-vinyl, a free radical polymerization initiator (photoinitiator or thermal initiator), a silicone-containing prepolymer, and combinations thereof, as is well known to those skilled in the art. this area. The resulting SiHy contact lenses are then subjected to an extraction using an extracting solvent to remove unpolymerized components from the resulting lenses and a hydration process, as is known to the person skilled in the art. In addition, the preformed SiHy contact lens may be a colored contact lens (i.e., a SiHy contact lens printed with at least one color pattern, as is well known to one skilled in the art).

According to the present invention, the silicone-containing vinyl monomer may be any silicone-containing vinyl monomer known to the person skilled in the art. Examples of preferred silicone-containing vinyl monomers include, without limitation, vinyl monomers each containing a bis(trialkylsilyloxy)alkylsilyl group or a tris(trialkylsilyloxy)silyl group, polysiloxane-vinyl monomers, 3-methacryloxypropylpentamethyldisiloxane, t-butyldimethylsiloxyethyl vinylcarbonate, trimethylsilylethylvinylcarbonate, and trimethylsilylmethylvinylcarbonate, and combinations thereof.

Preferred polysiloxane-vinyl monomers, including those of formula (M1), are described later in this application and can be obtained from commercial suppliers (eg, Shin-Etsu, Gelest, etc.); obtained in accordance with the procedures described in patents, for example, US patent No. 5070215, 6166236, 6867245, 8415405, 8475529, 8614261 and 9217813; prepared by reacting hydroxyalkyl(meth)acrylate or (meth)acrylamide or (meth)acryloxypolyethylene glycol with monoepoxypropyloxypropyl terminated polydimethylsiloxane; prepared by reacting glycidyl(meth)acrylate with monocarbinol-terminated polydimethylsiloxane, monoaminopropyl-terminated polydimethylsiloxane, or monoethylaminopropyl-terminated polydimethylsiloxane, or obtained by reacting isocyanate-ethyl(meth)acrylate with monocarbinol-terminated polydimethylsiloxane according to coupling reactions, good known to the person skilled in the art.

Preferred silicone-containing vinyl monomers each containing a bis(trialkylsilyloxy)alkylsilyl group or a tris(trialkylsilyloxy)silyl group, including monomers of formula (M2), are described later in this application and can be obtained from commercial suppliers (e.g., Shin-Etsu , Gelest, etc.) or can be prepared according to the procedures described in US Pat.

Any suitable polysiloxane-vinyl crosslinker may be used in the present invention. Examples of preferred polysiloxane-vinyl crosslinkers are di(meth)acryloyl terminated polydimethylsiloxanes; divinyl carbonate terminated polydimethylsiloxanes; divinylcarbamate-terminated polydimethylsiloxane; N, N, N', N'-tetrakis(3-methacryloxy-2-hydroxypropyl)-alpha,omega-bis-3-aminopropylpolydimethylsiloxane; a polysiloxane-containing macromer selected from the group consisting of macromer A, macromer B, macromer C and macromer D described in US 5,760,100; polysiloxane-containing macromers disclosed in US Pat. 398, 4605712, 4661575, 4684538, 4703097, 4833218, 4837289, 4954586, 4954587, 5010141 . 62264; polysiloxane-containing macromers disclosed in US Pat. Nos. 4,259,467, 4,260,725, and 4,261,875.

One class of preferred polysiloxane-vinyl crosslinkers are di(meth)acryloyloxy-terminated polysiloxane-vinyl crosslinkers each containing dimethylsiloxane units and hydrophilized siloxane units each containing one methyl substituent and one substituent representing the monovalent organic radical C ₄ -C ₄₀ containing from 2 to 6 hydroxyl groups, more preferably a polysiloxane-vinyl crosslinker of formula (I), while they are described later in this application and can be obtained in accordance with the procedures disclosed in US patent No. 10081697.

Another class of preferred polysiloxane-vinyl crosslinkers are the vinyl crosslinkers of formula (1), which are described later in this application and can be obtained from commercial suppliers; prepared by reacting glycidyl(meth)acrylate(meth)acryloyl chloride with diamino-terminated polydimethylsiloxane or dihydroxyl-terminated polydimethylsiloxane; obtained by the reaction of isocyanate-ethyl (meth)acrylate with dihydroxy-terminated polydimethylsiloxanes; obtained by reacting an amine-containing acrylic monomer with dicarboxy-terminated polydimethylsiloxane in the presence of a coupling agent (carbodiimide); obtained by reacting a carboxy-containing acrylic monomer with a diamino-terminated polydimethylsiloxane in the presence of a coupling agent (carbodiimide), or obtained by reacting a hydroxyl-containing acrylic monomer with a dihydroxy-terminated polydimethylsiloxane in the presence of a coupling agent which is a diisocyanate or a diepoxide.

Other classes of preferred polysiloxane-vinyl crosslinkers are chain extended polysiloxane-vinyl crosslinkers of any of formulas (2)-(7), which are described later in this application and can be obtained in accordance with the procedures described in US patent No. 5034461 , 5416132, 5449729, 5760100, 7423074, 8529057, 8835525, 8993651 and 10301451 and U.S. Application Publication No. 2018-0100038 A1.

Any suitable hydrophilic vinyl monomers can be used in the present invention. Examples of preferred hydrophilic vinyl monomers are alkyl (meth)acrylamides (as described later in this application), hydroxyl-containing acrylic monomers (as described below), amine-containing acrylic monomers (as described later in this application), carboxyl-containing acrylic monomers (as described later in this application). application), N-vinylamide monomers (as described hereinafter), methylene-containing pyrrolidone monomers (i.e., pyrrolidone derivatives each containing a methylene group bonded to the pyrrolidone ring at position 3 or 5) (as described further in this application), acrylic monomers containing a C ₁ -C ₄ alkoxyethoxy group (as described later in this application), vinyl ether monomers (as described later in this application), allyl ether monomers (as described later in this application), phosphorylcholine-containing vinyl monomers ( as described hereinafter), N-2-hydroxyethyl vinyl carbamate, N-carboxyvinyl-β-alanine (VINAL), N-carboxyvinyl-α-alanine, and combinations thereof.

According to the present invention, any hydrophobic vinyl monomers can be used. Examples of preferred hydrophobic methyl monomers include methyl (meth)acrylate, ethyl (meth)acrylate, propyl (meth)acrylate, isopropyl (meth)acrylate, cyclohexyl (meth)acrylate, 2-ethylhexyl (meth)acrylate, vinyl acetate, vinyl propionate, vinyl butyrate, vinyl valerate, styrene, chloroprene, vinyl chloride, vinylidene chloride, (meth) acrylonitrile, 1-butene, butadiene, vinyl toluene, vinyl ethyl ether, perfluoroethylhexyl-thio-carbonyl-aminoethyl-methacrylate, isobornyl-(meth)acrylate, trifluoroethyl -(meth)acrylate, hexafluoroisopropyl-(meth)acrylate, hexafluorobutyl-(meth)acrylate and combinations thereof.

According to the present invention, any cross-linking compounds other than siloxane-vinyl can be used. Examples of preferred crosslinkers other than siloxane-vinyl are described later in this application.

Any suitable thermal polymerization initiators may be used in the present invention. Suitable thermal polymerization initiators are known to the person skilled in the art and include, for example, peroxides, hydroperoxides, azo-bis(alkyl- or cycloalkylnitriles), persulfates, percarbonates, or mixtures thereof. Examples of preferred thermal polymerization initiators include, but are not limited to, benzoyl peroxide, t-butyl peroxide, t-amyl peroxybenzoate, 2,2-bis(t-butylperoxy)butane, 1,1-bis(t-butylperoxy)cyclohexane, 2,5-bis(t- butylperoxy)-2,5-dimethylhexane, 2,5-bis(tert-butylperoxy)-2,5-dimethyl-3-hexine, bis(1-(tert-butylperoxy)-1-methylethyl)benzene, 1,1- bis(tert-butylperoxy)-3,3,5-trimethylcyclohexane, di-tert-butyldiperoxyphthalate, tert-butyl hydroperoxide, tert-butylperacetate, tert-butylperoxybenzoate, tert-butylperoxyisopropyl carbonate, acetyl peroxide, lauroyl peroxide, decanoyl peroxide, dicetyl peroxydicarbonate, di(4-tert -butylcyclohexyl)peroxydicarbonate (Perkadox 16S), di(2-ethylhexyl)peroxydicarbonate, tert-butylperoxypivalate (Lupersol 11); tert-butylperoxy-2-ethylhexanoate (Trigonox 21-C50), 2,4-pentanedione peroxide, dicumyl peroxide, peracetic acid, potassium persulfate, sodium persulfate, ammonium persulfate, 2,2'-azobis(4-methoxy-2,4- dimethylvaleronitrile) (VAZO 33), 2,2'-azobis[2-(2-imidazolin-2-yl)propan]dihydrochloride (VAZO 44), 2,2'-azobis(2-amidinopropane)dihydrochloride (VAZO 50), 2,2'-azobis(2,4-dimethylvaleronitrile) (VAZO 52), 2,2'-azobis(isobutyronitrile) (VAZO 64 or AIBN), 2,2'-azobis-2-methylbutyronitrile (VAZO 67), 1 ,1'-azobis(1-cyclohexanecarbonitrile) (VAZO 88); 2,2'-azobis(2-cyclopropylpropionitrile), 2,2'-azobis(methylisobutyrate), 4,4'-azobis(4-cyanovaleric acid) and combinations thereof. Preferably the thermal initiator is 2,2'-azobis(isobutyronitrile) (AIBN or VAZO 64).

Suitable photoinitiators are benzoin methyl ester, diethoxyacetophenone, benzoylphosphine oxide, 1-hydroxycyclohexylphenyl ketone, and the Darocur and Irgacur types, preferably Darocur 1173® and Darocur 2959®, germanium based Norrish type I photoinitiators (for example, the photoinitiators described in US 7605190). Examples of benzoylphosphine-based initiators include 2,4,6-trimethylbenzoyldiphenylphosphine oxide; bis-(2,6-dichlorobenzoyl)-4-N-propylphenylphosphine oxide; and bis-(2,6-dichlorobenzoyl)-4-N-butylphenylphosphine oxide. Also suitable are reactive photoinitiators which can be incorporated, for example, into a macromer or can be used as a dedicated monomer. Examples of reactive photoinitiators are those disclosed in EP 632329.

The SiHy contact lens composition may also contain other necessary components known to the person skilled in the art, such as, for example, UV absorbing vinyl monomer, high energy violet light absorbing ("HEVL") vinyl monomer, color manipulation agent (e.g., reactive dyes). , polymerizable dyes, pigments or mixtures thereof, well known to the person skilled in the art), antimicrobial agents (for example, preferably silver nanoparticles), biologically active agent, leachable polymeric wetting agents (for example, non-polymerizable hydrophilic polymers, etc.), leachable agents , stabilizing the composition of the lacrimal fluid (for example, phospholipids, monoglycerides, diglycerides, triglycerides, glycolipids, glyceroglycolipids, sphingolipids, sphingoglycolipids, etc.), and mixtures thereof, as is known to a person skilled in the art.

The polymerizable composition (SiHy lens formulation) may be a clear, solvent-free liquid obtained by mixing all of the polymerizable components and another required component, or a solution obtained by dissolving all of the required components in any suitable solvent such as a mixture of water and one or more miscible water of organic solvents, an organic solvent, or a mixture of one or more organic solvents, as is known to the person skilled in the art. The term "solvent" refers to a chemical that cannot participate in a free radical polymerization reaction.

The solvent-free SiHy lens composition typically includes at least one miscible vinyl monomer as a reactive solvent for dissolving the other polymerizable components of the solvent-free SiHy lens composition. Examples of preferred miscible vinyl monomers are described later in this application. Preferably, methyl methacrylate is used as the miscible vinyl monomer to prepare the solvent-free SiHy lens composition.

Any solvents can be used in this invention. Examples of preferred organic solvents include, without limitation, tetrahydrofuran, tripropylene glycol methyl ether, dipropylene glycol methyl ether, ethylene glycol n-butyl ether, ketones (e.g., acetone, methyl ethyl ketone, etc.), diethylene glycol n-butyl ether, diethylene glycol methyl ether, ethylene glycol phenyl ether , methyl-gang glycol ether, propylene glycolmethyl ester acetate, diprophylene glycol-glyculometric acetate, propylene glycol, non-prototyl glycol ether, three-butyl glycol, n-butille ether of pre-pylenglycol, n-butyle ethrum Fir Dipropylene Glycol, n-butyl ether of the triprophylene glycol, phenylo propylene glycol ether, dipropylene glycol dimethyl ether, polyethylene glycols, polypropylene glycols, ethyl acetate, butyl acetate, amyl acetate, methyl lactate, ethyl lactate, isopropyl lactate, methylene chloride, 2-butanol, 1-propanol, 2-propanol, menthol, cyclohexanol, cyclopentanol and exonorborneol, 2-pentanol, 3 -pentanol, 2-hexanol, 3-hexanol, 3-methyl-2-butanol, 2-heptanol, 2-octanol, 2-nonanol, 2-decanol, 3-octanol, norborneol, tert-butanol, tert-amyl alcohol, 2-methyl-2-pentanol, 2,3-dimethyl-2-butanol, 3-methyl-3-pentanol, 1-methylcyclohexanol, 2-methyl-2-hexanol, 3,7-dimethyl-3-octanol, 1- chloro-2-methyl-2-propanol, 2-methyl-2-heptanol, 2-methyl-2-octanol, 2-2-methyl-2-nonanol, 2-methyl-2-decanol, 3-methyl-3- hexanol, 3-methyl-3-heptanol, 4-methyl-4-heptanol, 3-methyl-3-octanol, 4-methyl-4-octanol, 3-methyl-3-nonanol, 4-methyl-4-nonanol, 3-methyl-3-octanol, 3-ethyl-3-hexanol, 3-methyl-3-heptanol, 4-ethyl-4-heptanol, 4-propyl-4-heptanol, 4-isopropyl-4-heptanol, 2, 4-dimethyl-2-pentanol, 1-methylcyclopentanol, 1-ethylcyclopentanol, 1-ethylcyclopentanol, 3-hydroxy-3-methyl-1-butene, 4-hydroxy-4-methyl-1-cyclopentanol, 2-phenyl-2- propanol, 2-methoxy-2-methyl-2-propanol, 2,3,4-trimethyl-3-pentanol, 3,7-dimethyl-3-octanol, 2-phenyl-2-butanol, 2-methyl-1- phenyl-2-propanol and 3-ethyl-3-pentanol, 1-ethoxy-2-propanol, 1-methyl-2-pyrrolidone, N,N-dimethylpropionamide, dimethylformamide, dimethylacetamide, dimethylpropionamide, N-methylpyrrolidinone and mixtures thereof.

Numerous SiHy lens formulations have been described in numerous patents and patent applications published as of the filing date of this application and are used in the manufacture of commercial SiHy contact lenses. Examples of commercial SiHy contact lenses include, without limitation, asmofilcon A, balafilcon A, comfilcon A, delefilcon A, efrofilcon A, enfilcon A, fanfilcon A, galyfilcon A, lotrafilcon A, lotrafilcon B, narafilcon A, narafilcon B, senofilcon A, senofilcon B, senofilcon C, smafilcon A, somofilcon A and stenfilcon A.

The SiHy lens formulation (ie, polymerizable composition) can be thermally or actinically cured (polymerized) as known to those skilled in the art, preferably in contact lens injection molds.

Thermal polymerization is usually carried out, for example, at a temperature of from 25 to 120°C and preferably from 40 to 100°C. The reaction time can be varied within wide limits, but is typically, for example, from 1 to 24 hours, or preferably from 2 to 12 hours. Preferably, the components and solvents used in the polymerization reaction are degassed beforehand, and said copolymerization reaction is carried out in an inert atmosphere, such as nitrogen or argon.

The actinic polymerization can then be activated by actinic radiation, for example light, in particular UV radiation or visible light with a suitable wavelength. If necessary, the spectrum requirements can be suitably controlled by the addition of suitable photosensitizers.

While various embodiments of the present invention have been described in terms of specific terms, devices, and methods, such description is provided for the purpose of illustration only. The words used are words of description, not limitation. A person skilled in the art should be obvious that many variations and modifications of the present invention can be made by experts in this field without departing from the essence and scope of the new concepts of the present invention. In addition, it should be understood that aspects of the various embodiments of the present invention may be interchangeable either in whole or in part, or may be combined in any way and/or used together, as shown below.

1. An ophthalmic product containing a sealed and autoclaved package that includes an autoclaved packaging solution and an easy-to-use silicone hydrogel contact lens immersed in it,

wherein the autoclaved packaging solution is a buffered saline solution having a pH of about 6.0 to about 8.0 and includes a polymeric surfactant that contains at least one hydrophilic poly(oxyethylene) segment and at least one hydrophobic poly(oxybutylene) segment and is characterized by an HLB value from about 11 to about 16 and a number average molecular weight from about 800 to about 20,000 daltons, where an easy-to-use silicone hydrogel contact lens is obtained by placing in a package, sealing and pre-autoclaving shaped silicone hydrogel contact lens in a packaging solution prior to autoclaving containing a polymeric surfactant, where the preformed silicone hydrogel contact lens does not contain any coating on it, while the easy-to-use silicone hydrogel contact lens contains a polymeric surfactant physically dispersed in a polymeric matrix of an easy-to-use silicone hydrogel contact lens, as evidenced by the ability to release polymeric surfactant in an amount of at least 0.2 µg/lens/24 hours, as measured in-process aqueous extraction, consisting of 7 extraction cycles in simulated 1-day wear, where the polymeric surfactant releasing capacity is the amount of polymeric surfactant released per lens over 24 hours into the extraction medium that was used in the last cycle of 7 extraction cycles while simulating 1-day wear, while the easy-to-use silicone hydrogel contact lens additionally has a first static water contact angle, WCA _OOP , of approximately 75 ^° or less, as measured immediately after opening the sealed package by the sessile drop method , a second static water contact angle, WCA _{7_S1DW} , of about 85 ^° or less as measured by the sessile drop method immediately after 7 extraction cycles in simulated 1-day wear, an oxygen permeability of at least 50 barrer, a modulus of elasticity of about 0, 2 MPa to about 1.5 MPa and an equilibrium moisture content of about 38% to about 80% by weight.

2. A method for obtaining ophthalmic products, including the steps:

a) placing and sealing the preformed silicone hydrogel contact lens in a container containing the packaging solution prior to autoclaving, where the preformed silicone hydrogel contact lens does not have any coating on it and has an oxygen permeability of at least 50 barrer, a modulus of elasticity from about 0.2 MPa to about 1.5 MPa and an equilibrium moisture content from about 38% to about 80% by weight, where the packaging solution prior to autoclaving is a buffered saline solution having a pH of from about 6.0 to about 8.0, and contains a polymeric surfactant that contains at least one hydrophilic poly(oxyethylene) segment and at least one hydrophobic poly(oxybutylene) segment and is characterized by an HLB value from about 11 to about 16 and a number average molecular weight from about 800 to about 20,000 daltons; And

b) autoclaving a sealed package containing a preformed silicone hydrogel contact lens for at least about 30 minutes to form an ophthalmic product, wherein the ophthalmic product comprises an easy-to-use silicone hydrogel contact lens immersed in a packaging solution after being processed in autoclaved, sealed and autoclaved packaging, wherein the easy-to-use silicone hydrogel contact lens contains a polymeric surfactant physically dispersed in a polymeric matrix of the easy-to-use silicone hydrogel contact lens, as evidenced by the ability to release the polymeric surfactant in an amount of at least 0.2 μg/lens/24 hours, as measured in a water extraction process consisting of 7 extraction cycles in simulated 1-day wear, characterized by a first static water contact angle, WCA _OOP , of approximately 75 ^o or less, as measured immediately after opening the sealed package by the sessile drop method, and a second static water contact angle, WCA _{7_S1DW} , of approximately 85 ^o or less, as measured by the sessile drop method immediately after 7 extraction cycles in simulated 1-day wear, where polymeric surfactant releasing capacity is the amount of polymeric surfactant released per lens over 24 hours into the extraction medium that was used in the last cycle of 7 extraction cycles in simulated 1-day wear.

3. The ophthalmic product of Embodiment 1 or the method of Embodiment 2, wherein the polymeric surfactant has a number average molecular weight of about 800 to about 10,000 daltons.

4. An ophthalmic product according to Embodiment 1 or a method according to Embodiment 2, wherein the polymeric surfactant has a number average molecular weight of from about 1000 to about 8000 daltons.

5. An ophthalmic product according to Embodiment 1, 3 or 4 or a method according to any of Embodiments 2-4, wherein the autoclaved packaging solution has a pH of about 6.5 to about 7.5.

6. The ophthalmic product according to any one of embodiments 1 and 3-5 or the method according to any one of embodiments 2-5, wherein the easy-to-use silicone hydrogel contact lens has a WCA _OOP of about 70 ^° or less, as measured immediately after opening the sealed package by sessile drop, and optionally WCA _{7_S1DW} of approximately 80 ^° or less as measured by sessile immediately after 7 extraction cycles in simulated 1-day wear.

7. An ophthalmic product according to any one of embodiments 1 and 3-5, or a method according to any one of embodiments 2-5, wherein the easy-to-use silicone hydrogel contact lens has a WCA _OOP of about 65 ^° or less, as measured immediately after opening the sealed package by sessile drop, and optionally WCA _{7_S1DW} of approximately 75 ^° or less as measured by sessile immediately after 7 extraction cycles in simulated 1-day wear.

8. The ophthalmic product according to any one of embodiments 1 and 3-5 or the method according to any one of embodiments 2-5, wherein the easy-to-use silicone hydrogel contact lens has a WCA _OOP of about 60 ^° or less, as measured immediately after opening the sealed package by sessile drop, and optionally WCA _{7_S1DW} of approximately 70 ^° or less as measured by sessile immediately after 7 extraction cycles in simulated 1-day wear.

9. The ophthalmic product according to any one of embodiments 1 and 3-8 or the method according to any one of embodiments 2-8, wherein the easy-to-use silicone hydrogel contact lens is characterized by the ability to release a polymeric surfactant in an amount of at least 0.4 μg/lens/24 hours, as measured in a water extraction process consisting of 7 extraction cycles while simulating 1-day wear.

10. The ophthalmic product according to any one of embodiments 1 and 3-8 or the method according to any one of embodiments 2-8, wherein the easy-to-use silicone hydrogel contact lens is characterized by the ability to release polymeric surfactant in an amount of at least 0.6 μg/lens/24 hours, as measured in a water extraction process consisting of 7 extraction cycles while simulating 1-day wear.

11. An ophthalmic product according to any one of embodiments 1 and 3-8, or a method according to any one of embodiments 2-8, wherein the easy-to-use silicone hydrogel contact lens is characterized by the ability to release a polymeric surfactant in an amount of at least 0.8 μg/lens/24 hours, as measured in a water extraction process consisting of 7 extraction cycles while simulating 1-day wear.

12. An ophthalmic product according to any one of embodiments 1 and 3-8, or a method according to any one of embodiments 2-8, wherein the easy-to-use silicone hydrogel contact lens is characterized by the ability to release a polymeric surfactant in an amount of at least 1.0 μg/lens/24 hours, as measured in a water extraction process consisting of 7 extraction cycles while simulating 1-day wear.

13. The ophthalmic product according to any one of embodiments 1 and 3-12, or the method according to any one of embodiments 2-12, wherein the polymeric surfactant is a diblock copolymer, referred to as PEO-PBO, or a triblock a copolymer designated as PEO-PBO-PEO or PBO-PEO-PBO, wherein PEO is a poly(oxyethylene) segment and PBO is a poly(oxybutylene) segment.

14. An ophthalmic product according to any of Embodiments 1 and 3-12, or a method according to any of Embodiments 2-12, wherein the polymeric surfactant is a diblock copolymer of formula (S1),

RO - (EO) _m (BO) _n - H (S1),

where R is selected from the group consisting of hydrogen, methyl, ethyl, propyl and butyl; EO is ethylene oxide -C ₂ H ₄ O-; BO is butylene oxide -C ₄ H ₈ O-; m is an integer having an average value of 10 to 250; and n is an integer having an average value of 5 to 125, with the proviso that m/n is from about 2:1 to about 10:1.

15. An ophthalmic product or method according to Embodiment 14 wherein in formula (S1) the m/n is from about 3:1 to about 6:1.

16. An ophthalmic product according to any of embodiments 1 and 3-12, or a method according to any of embodiments 2-12, wherein the polymeric surfactant is a diblock copolymer of formula (S2),

(S2)

where R is selected from the group consisting of hydrogen, methyl, ethyl, propyl and butyl; m is an integer having an average value of 10 to 250; and n is an integer having an average value of from 5 to 125, provided that the value of m/n is from about 2:1 to about 10:1.

17. An ophthalmic product or method according to Embodiment 16 wherein in formula (S1), m/n is from about 3:1 to about 6:1.

18. An ophthalmic product or method according to Embodiment 16 or Embodiment 17, wherein in formula (S1), R is methyl.

19. The ophthalmic product or method according to any one of embodiments 16-18, wherein in formula (S1), m has a mean value of 45 and n has a mean value of 10.

20. An ophthalmic product according to any of embodiments 1 and 3-19, or a method according to any of embodiments 2-19, wherein the easy-to-use silicone hydrogel contact lens contains at least about 25 μg/lens of a polymeric surface active substance.

21. An ophthalmic product according to any one of embodiments 1 and 3-19, or a method according to any one of embodiments 2-19, wherein the easy-to-use silicone hydrogel contact lens contains at least about 30 μg/lens of a polymeric surface active substance.

22. An ophthalmic product according to any one of embodiments 1 and 3-19, or a method according to any one of embodiments 2-19, wherein the easy-to-use silicone hydrogel contact lens contains at least about 35 μg/lens of a polymeric surface active substance.

23. An ophthalmic product according to any of embodiments 1 and 3-19, or a method according to any of embodiments 2-19, wherein the easy-to-use silicone hydrogel contact lens contains at least about 40 μg/lens of a polymeric surface active substance.

24. An ophthalmic product according to any of embodiments 1 and 3-19, or a method according to any of embodiments 2-19, wherein the easy-to-use silicone hydrogel contact lens contains at least about 50 μg/lens of a polymeric surface active substance.

25. An ophthalmic product according to any one of embodiments 1 and 3-19, or a method according to any one of embodiments 2-19, wherein the easy-to-use silicone hydrogel contact lens contains at least about 60 μg/lens of a polymeric surfactant. active substance.

26. An ophthalmic product according to any one of embodiments 1 and 3-19, or a method according to any one of embodiments 2-19, wherein the easy-to-use silicone hydrogel contact lens contains at least about 70 μg/lens of a polymeric surfactant. active substance.

27. An ophthalmic product according to any one of embodiments 1 and 3-19, or a method according to any one of embodiments 2-19, wherein the easy-to-use silicone hydrogel contact lens contains at least about 80 μg/lens of a polymeric surfactant. active substance.

28. An ophthalmic product according to any of embodiments 1 and 3-19, or a method according to any of embodiments 2-19, wherein the easy-to-use silicone hydrogel contact lens contains at least about 90 μg/lens of a polymeric surface active substance.

29. An ophthalmic product according to any of embodiments 1 and 3-28, or a method according to any of embodiments 2-28, wherein the packaging solution prior to autoclaving further comprises from about 0.1% to about 2% by weight a hydrophilic polymer having a number average molecular weight of at least 100,000 daltons.

30. An ophthalmic product according to any of embodiments 1 and 3-28, or a method according to any of embodiments 2-28, wherein the packaging solution prior to autoclaving further comprises from about 0.1% to about 2% by weight a hydrophilic polymer having a number average molecular weight of at least 200,000 daltons.

31. An ophthalmic product or method according to embodiment 29 or 30, wherein the hydrophilic polymer is polyvinylpyrrolidone.

32. The ophthalmic product or method according to embodiment 29 or 30, wherein the hydrophilic polymer is a copolymer of N-vinylpyrrolidone and at least one amine-containing vinyl monomer, wherein the amine-containing vinyl monomer is selected from the group consisting of an alkylaminoalkyl methacrylate containing 8-15 atoms carbon, alkylaminoalkyl acrylate containing 7-15 carbon atoms, dialkylaminoalkyl methacrylate containing 8-20 carbon atoms, dialkylaminoalkyl acrylate containing 7-20 carbon atoms, and N-vinylalkylamide containing 3-10 carbon atoms.

33. An ophthalmic product or method according to embodiment 31 or 32, wherein the amine-containing vinyl monomer is dimethylaminoethyl methacrylate or dimethylaminoethyl acrylate.

34. An ophthalmic product according to any of embodiments 1 and 3-33 or a method according to any of embodiments 2-33, wherein the easy-to-use silicone hydrogel contact lens has an oxygen permeability of about 60 to about 180 barre.

35. An ophthalmic product according to any of Embodiments 1 and 3-33 or a method according to any of Embodiments 2-33, wherein the easy-to-use silicone hydrogel contact lens has an oxygen permeability of about 70 to about 180 barre.

36. An ophthalmic product according to any of Embodiments 1 and 3-33 or a method according to any of Embodiments 2-33, wherein the easy-to-use silicone hydrogel contact lens has an oxygen permeability of about 80 barre to about 180 barre.

37. An ophthalmic product according to any of Embodiments 1 and 3-33 or a method according to any of Embodiments 2-33, wherein the easy-to-use silicone hydrogel contact lens has an oxygen permeability of about 90 barre to about 180 barre.

38. An ophthalmic product according to any one of embodiments 1 and 3-37, or a method according to any one of embodiments 2-37, wherein the easy-to-use silicone hydrogel contact lens has an equilibrium moisture content of about 40% to about 80% by weight. weight.

39. An ophthalmic product according to any one of embodiments 1 and 3-37, or a method according to any one of embodiments 2-37, wherein the easy-to-use silicone hydrogel contact lens has an equilibrium moisture content of about 45% to about 80% by weight. weight.

40. An ophthalmic product according to any one of embodiments 1 and 3-39 or a method according to any one of embodiments 2-39, wherein the easy-to-use silicone hydrogel contact lens has an elastic modulus of about 0.3 MPa to about 1 .3 MPa.

41. An ophthalmic product according to any of embodiments 1 and 3-39, or a method according to any of embodiments 2-39, wherein the easy-to-use silicone hydrogel contact lens has an elastic modulus of about 0.4 MPa to about 1 .2 MPa.

42. An ophthalmic product according to any of Embodiments 1 and 3-41, or a method according to any of Embodiments 2-41, wherein the preformed silicone hydrogel contact lens is a naturally wetted silicone hydrogel contact lens.

43. An ophthalmic product according to any one of embodiments 1 and 3-42, or a method according to any one of embodiments 2-42, wherein the preformed silicone hydrogel contact lens is comprised of a silicone hydrogel material containing repeating units of at least one silicone-containing vinyl monomer selected from the group consisting of a vinyl monomer containing a bis(trialkylsilyloxy)alkylsilyl group, a vinyl monomer containing a tris(trialkylsilyloxy)silyl group, a polysiloxane-vinyl monomer, 3-methacryloxypropylpentamethyldisiloxane, tert-butyldimethylsiloxyethylvinylcarbonate, trimethylsilylethylvinylcarbonate, and trimethylsilylmethylvinylcarbonate a and their combinations.

44. An ophthalmic product or method according to embodiment 43, wherein said at least one silicone-containing vinyl monomer provides a vinyl monomer of formula (M1) or (M2),

where a1 is zero or 1; R _o is H or methyl; X _o is O or NR ₁ ; L ₁ is a C ₂ -C ₈ alkylene divalent radical or divalent radical

L ₁ ' is a C ₂ -C ₈ alkylene divalent radical which contains or does not contain one hydroxyl group; L ₁ "is a C ₃ -C ₈ alkylene divalent radical which contains or does not contain one hydroxyl group; X ₁ is O, NR ₁ , NHCOO, OCONH, CONR ₁ or NR ₁ CO; R ₁ is H or C ₁ -C ₄ alkyl containing 0 to 2 hydroxyl groups; R _t1 and R _t2 are independently C ₁ -C ₆ alkyl; X ₁ ' is O or NR ₁ ; q1 is an integer from 1 to 30; q2 is an integer from 0 to 30; n1 is an integer from 3 to 40; and r1 is an integer that is 2 or 3.

45. An ophthalmic product or method according to embodiment 43 or 44, wherein said at least one silicone-containing vinyl monomer comprises tris(trimethylsilyloxy)silylpropyl(meth)acrylate, [3-(meth)acryloxy-2-hydroxypropyloxy]propylbis(trimethylsiloxy )methylsilane, [3-(meth)acryloxy-2-hydroxypropyloxy]propylbis(trimethylsiloxy)butylsilane, 3-(meth)acryloxy-2-(2-hydroxyethoxy)propyloxy)propylbis(trimethylsiloxy)methylsilane, 3-(meth)acryloxy- 2-hydroxypropyloxy)propyltris(trimethylsiloxy)silane, N-[tris(trimethylsiloxy)silylpropyl](meth)acrylamide, N-(2-hydroxy-3-(3-(bis(trimethylsilyloxy)methylsilyl)propyloxy)propyl)-2- methyl(meth)acrylamide, N-(2-hydroxy-3-(3-(bis(trimethylsilyloxy)methylsilyl)propyloxy)propyl)(meth)acrylamide, N-(2-hydroxy-3-(3-(tris(trimethylsilyloxy) )silyl)propyloxy)propyl)-2-methylacrylamide, N-(2-hydroxy-3-(3-(tris(trimethylsilyloxy))silyl)propyloxy)propyl)(meth)acrylamide, N-[tris(dimethylpropylsiloxy)silylpropyl] (meth)acrylamide, N-[tris(dimethylphenylsiloxy)silylpropyl](meth)acrylamide, N-[tris(dimethylethylsiloxy)silylpropyl](meth)acrylamide, N,N-bis[2-hydroxy-3-(3-(bis (trimethylsilyloxy)methylsilyl)propyloxy)propyl]-2-methyl(meth)acrylamide, N,N-bis[2-hydroxy-3-(3-(bis(trimethylsilyloxy)methylsilyl)propyloxy)propyl](meth)acrylamide, N ,N-bis[2-hydroxy-3-(3-(tris(trimethylsilyloxy)silyl)propyloxy)propyl]-2-methyl(meth)acrylamide, N,N-bis[2-hydroxy-3-(3-( tris(trimethylsilyloxy)silyl)propyloxy)propyl](meth)acrylamide, N-[2-hydroxy-3-(3-(tert-butyldimethylsilyl)propyloxy)propyl]-2-methyl(meth)acrylamide, N-[2- hydroxy-3-(3-(tert-butyldimethylsilyl)propyloxy)propyl](meth)acrylamide, N,N-bis[2-hydroxy-3-(3-(tert-butyldimethylsilyl)propyloxy)propyl]-2-methyl( meth)acrylamide, N-2-(meth)acryloxyethyl-O-(methyl-bis-trimethylsiloxy-3-propyl)silylcarbamate, 3-(trimethylsilyl)propylvinyl carbonate, 3-(vinyloxycarbonylthio)propyl-tris(trimethylsiloxy)silane, 3- [tris(trimethylsiloxy)silyl]propylvinyl carbamate, 3-[tris(trimethylsiloxy)silyl]propylallyl carbamate, 3-[tris(trimethylsiloxy)silyl]propylvinyl carbonate or a combination thereof.

46. An ophthalmic product or method according to any one of embodiments 43-45, wherein said at least one silicone-containing vinyl monomer comprises an α-(meth)acryloxypropyl and ω-C ₁ -C ₄ alkyl terminated polydimethylsiloxane, α-(meth)acryloxy-2-hydroxypropyloxypropyl and ω-C ₁ -C ₄ alkyl groups, α-(2-hydroxymethacryloxypropyloxypropyl) -ω-C ₁ -C ₄ alkyldecamethylpentasiloxane, polydimethylsiloxane with terminal α-[3-(meth)acryloxyethoxy -2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[3-(meth)acryloxypropyloxy-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[ 3-(meth)acryloxyisopropyloxy-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[3-(meth)acryloxybutyloxy-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[3-(meth)acryloxyethylamino-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[3-(meth)acryloxypropylamino-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[3-(meth)acryloxybutylamino-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-(meth)acryloxy(polyethyleneoxy)-2-hydroxypropyloxypropyl ] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[(meth)acryloxy-2-hydroxypropyloxyethoxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[(meth)acryloxy-2 -hydroxypropyl-N-ethylaminopropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[(meth)acryloxy-2-hydroxypropylaminopropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[ (meth)acryloxy-2-hydroxypropyloxy(polyethyleneoxy)propyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-(meth)acryloylamidopropyloxypropyl and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-N -methyl(meth)acryloylamidopropyloxypropyl and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[3-(meth)acrylamidoethoxy-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α- [3-(meth)acrylamidopropyloxy-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[3-(meth)acrylamidoisopropyloxy-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups _{. _ 1} -C ₄ alkyl groups, polydimethylsiloxane with terminal α-[3-[N-methyl (meth)acryloylamido]-2-hydroxypropyloxypropyl] and ω-C ₁ -C ₄ alkyl groups, N-methyl-N'-(propyltetra( dimethylsiloxy)dimethylbutylsilane)(meth)acrylamide, N-(2,3-dihydroxypropane)-N'-(propyltetra(dimethylsiloxy)dimethylbutylsilane)(meth)acrylamide, (meth)acryloylamidopropyltetra(dimethylsiloxy)dimethylbutylsilane, polydimethylsiloxanes with terminal α-vinyl carbonate and ω-C ₁ -C ₄ alkyl groups, polydimethylsiloxane with terminal α-vinylcarbamate and ω-C ₁ -C ₄ alkyl groups, or a mixture thereof.

47. An ophthalmic product or method according to any one of embodiments 43-46, wherein the silicone hydrogel material contains repeating units of at least one polysiloxane-vinyl crosslinker.

48. An ophthalmic product or method according to embodiment 47, wherein said at least one polysiloxane-vinyl crosslinker comprises di(meth)acryloyl-terminated polydimethylsiloxane, divinyl carbonate-terminated polydimethylsiloxane; divinylcarbamate-terminated polydimethylsiloxane; N, N, N', N'-tetrakis(3-methacryloxy-2-hydroxypropyl)-alpha, omega-bis-3-aminopropylpolydimethylsiloxane, or a combination thereof.

49. An ophthalmic product or method according to embodiment 47, wherein said at least one polysiloxane-vinyl crosslinker comprises a vinyl crosslinker of formula (I),

wherein

υ1 is an integer from 30 to 500, and ω1 is an integer from 1 to 75, provided that ω1/υ1 is from about 0.035 to about 0.15 (preferably from about 0.040 to about 0.12, even more preferably from about 0.045 to about 0.10);

X ₀₁ represents O or NR _N in which _RN represents hydrogen or C ₁ -C ₁₀ alkyl;

R _o is hydrogen or methyl;

R _I1 and R _I2 independently of each other represent a substituted or unsubstituted C ₁ -C ₁₀ alkylene divalent radical or divalent radical -R _I4 -OR _I5 -, while R _I4 and R _I5 independently of each other represent a substituted or unsubstituted C ₁ -C ₁₀ alkylene divalent radical;

R _I3 is a monovalent radical of any of the formulas (Ia)-(Ie),

p1 is zero or 1; m1 is an integer from 2 to 4; m2 is an integer from 1 to 5; m3 is an integer from 3 to 6; m4 is an integer from 2 to 5;

R _I6 is hydrogen or methyl;

R _I7 is a C ₂ -C ₆ hydrocarbon radical having a valency (m2+1);

R _I8 is a C ₂ -C ₆ hydrocarbon radical having a valency (m4+1);

R _I9 is ethyl or hydroxymethyl;

R _I10 is methyl or hydroxymethyl;

R _I11 is hydroxyl or methoxy;

X _I1 is a sulfur bridge -S- or a tertiary amine bridge -NR _I12 - in which R _I12 is C ₁ -C ₁ alkyl, hydroxyethyl, hydroxypropyl or 2,3-dihydroxypropyl; And

X _I2 is an amide bridge or , in which R _I13 represents hydrogen or C ₁ -C ₁₀ alkyl.

50. An ophthalmic product or method according to Embodiment 47, wherein said at least one polysiloxane-vinyl crosslinker comprises a vinyl crosslinker of any of formulas (1) to (7),

in which

υ1 is an integer from 30 to 500;

υ2 is an integer from 5 to 50;

υ3 is an integer from 5 to 100;

ω2 and ω3 are independently an integer from 1 to 15;

a1 and g1 are independently equal to zero or 1;

h1 is an integer from 1 to 20, and h2 is an integer from 0 to 20;

m1 and m3 are independently 0 or 1, m2 is an integer from 1 to 6, m4 is an integer from 1 to 5, m5 is 2 or 3;

q1 is an integer from 1 to 20, q2 is an integer from 0 to 20, q3 is an integer from 0 to 2, q4 is an integer from 2 to 50, q5 and q6 independently of each other are a number from 0 to 35, provided that (q4+q5+q6) is an integer from 2 to 50;

x+y is an integer from 10 to 30;

e1 is an integer from 5 to 100, p1 and b1 independently of each other are an integer from 0 to 50, provided that (e1+p1+b1)≥10 and ≥ 2 (preferably from about 2:1 to about 10:1, more preferably from about 3:1 to about 6:1) if (p1+b1)≥1;

R _o is H or methyl;

R ₁ , R _1n , R _2n , R _3n and R _4n independently of each other represent H or C ₁ -C ₄ alkyl containing from 0 to 2 hydroxyl groups;

R _n5 is H or C ₁ -C ₁₀ alkyl;

R ₂ is a C ₄ -C ₁₄ hydrocarbon divalent radical;

R ₃ is a C ₂ -C ₆ alkylene divalent radical;

R ₄ and R ₅ are independently a C ₁ -C ₆ alkylene divalent radical or a C ₁ -C ₆ alkyleneoxy-C ₁ -C ₆ alkylene divalent radical;

R ₆ and R ₇ independently of each other represent a C ₁ -C ₆ alkylene divalent radical or a C ₁ -C ₆ alkoxy-C ₁ -C ₆ alkylene divalent radical;

R ₈ and R ₉ independently of each other represent a substituted or unsubstituted C ₁ -C ₁₂ alkylene divalent radical;

X _o , X ₁ ', X _o1 , X ₀₂ and X ₀₃ are independently O or NR ₁ ;

X ₁ is O, NR ₁ , NHCOO, OCONH, CONR ₁ or NR ₁ CO;

X _o4 is -COO- or -CONR _n5 -;

X _o5 and X _o7 independently represent a direct link, -COO- or -CONR _n5 -;

X _o6 is a direct bond, C ₁ -C ₆ alkylene divalent radical, C ₁ -C ₆ alkyleneoxy divalent radical, -COO- or -CONR _n5 -;

X _o8 is a direct link or -COO-;

X _o9 is O or NR _n5 ;

X ₁₀ is a direct bond, C ₁ -C ₆ alkylene divalent radical, -COO- or -CONR _n5 -;

E ₁ ' is a monovalent radical ;

E ₂ is a monovalent radical ;

E ₃ is a monovalent radical ;

E ₄ is a monovalent radical or ;

L ₁ is a C ₂ -C ₈ alkylene divalent radical or divalent radical

L ₁ ' is a C ₂ -C ₈ alkylene divalent radical which contains or does not contain one hydroxyl group;

L ₁ "is a C ₃ -C ₈ alkylene divalent radical, which contains one hydroxyl group or does not contain it;

L ₃ is a divalent radical , while PE is a divalent radical or ;

L ₃ ' is a C ₃ -C ₈ alkylene divalent radical;

L ₄ is a divalent radical

hp L ₁ is a divalent radical

;

hp L ₂ is a divalent radical ;

hp L ₃ is a divalent radical ;

hp L ₄ is a divalent radical or ;

pOAlk is a divalent radical , while EO is an oxyethylene unit (-CH ₂ CH ₂ O-), PO is an oxypropylene unit ( ), and BO is an oxybutylene unit ( );

M ₀ is a C ₃ -C ₈ alkylene divalent radical;

M ₁ is a C ₄ -C ₁₄ hydrocarbon divalent radical;

M ₂ and M ₃ independently of each other represent a C ₁ -C ₆ alkylene divalent radical;

J ₀ is a C ₁ -C ₁₂ hydrocarbon radical containing from 0 to 2 hydroxyl or carboxyl groups;

G1 is a direct bond, C ₁ -C ₄ alkylene divalent radical or divalent radical

in which M _o is associated with the Si atom, while X ₀₄ -X ₁₀ are associated with the -CH ₂ - group in formula (7), and at least one of J ₀ and G1 in formula (7) contains at least one fragment selected from the group consisting of hydroxyl groups, urethane bridge -OCONH-, amino groups -NHR ^o , amine bridges -NH-, amide bridges -CONH-, carboxyl groups and combinations thereof;

G ₂ is a C ₁ -C ₄ alkylene divalent radical or divalent radical

G ₃ is a divalent radical , where h3 and h4 are independently 1 or 0;

G4 is a divalent radical, which is any of (a) -NR ₃ '-, in which R ₃ ' represents hydrogen or C ₁ -C ₃ alkyl, (b) , (c) -NR ₀ -G ₅ -NR ₀ -, in which G ₅ represents a C ₁ -C ₆ alkylene divalent radical, 2-hydroxylpropylene divalent radical, 2-(phosphonyloxy)propylene divalent radical, 1,2-dihydroxyethylene divalent radical, 2,3-dihydroxybutylene divalent radical, and (d) -OG ₆ -O-, in which G ₆ represents C ₁ -C ₆ alkylene divalent radical, divalent radical , in which h4' equals 1 or 2, divalent radical , divalent radical , where h5 is an integer from 1 to 5, a divalent radical in which h6 is 2 or 3, or a substituted C ₃ -C ₈ alkylene divalent radical containing a hydroxyl group or a phosphonyloxy group;

Y ₁ is a C ₁ -C ₆ alkylene divalent radical, 2-hydroxylpropylene divalent radical, 2-(phosphonyloxy)propylene divalent radical, 1,2-dihydroxyethylene divalent radical, divalent radical or divalent radical ;

Y ₂ is a divalent radical ;

Y ₃ is a divalent radical or ;

Z ₀ is a direct bond or a C ₁ -C ₁₂ alkylene divalent radical;

Z ₁ is a C ₁ -C ₆ alkylene divalent radical, a hydroxyl or methoxy substituted C ₁ -C ₆ alkylene divalent radical, or a substituted or unsubstituted phenylene divalent radical,

Z ₂ is a C ₁ -C ₆ alkylene divalent radical, hydroxyl or methoxy substituted C ₁ -C ₆ alkylene divalent radical, dihydroxyl or dimethoxy substituted C ₂ -C ₆ alkylene divalent radical, divalent radical -C ₂ H ₄ -(OC ₂ H ₄ ) _m2 -, divalent radical -Z ₄ -SSZ ₄ -, hydroxyl- or methoxy-substituted C ₁ -C ₆ alkylene divalent radical or substituted or unsubstituted phenylene divalent radical,

Z ₃ is a divalent radical representing any of (a) -NR _n3 -, (b) , (c) -NR ₀ -Z ₅ -NR ₀ - and (d) -OZ ₆ -O-,

Z ₄ is a C ₁ -C ₆ alkylene divalent radical,

Z ₅ is a C ₁ -C ₆ alkylene divalent radical, 2-hydroxylpropylene divalent radical, 2-(phosphonyloxy)propylene divalent radical, 1,2-dihydroxyethylene divalent radical, 2,3-dihydroxybutylene divalent radical,

Z ₆ is (a) C ₁ -C ₆ alkylene divalent radical, (b) divalent radical , , , or (c) a substituted C ₃ -C ₈ alkylene divalent radical containing a hydroxyl group or a phosphonyloxy group,

Z ₇ is a divalent radical .

51. An ophthalmic product or method according to Embodiment 47, wherein said at least one polysiloxane-vinyl crosslinker is α,ω-bis[3-(meth)acrylamidopropyl]-terminated polydimethylsiloxane, α,ω-terminated polydimethylsiloxane -bis[3-(meth)acryloxypropyl] groups, α,ω-bis[3-(meth)acryloxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxyethoxy- 2-hydroxypropyloxypropyl] groups, α,ω-bis[3-(meth)acryloxypropyloxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxyisopropyloxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxybutyloxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidoethoxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-terminated polydimethylsiloxane -bis[3-(meth)acrylamidopropyloxy-2-hydroxypropyloxypropyl] groups, α,ω-bis[3-(meth)acrylamidoisopropyloxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-( meth)acrylamidobutyloxy-2-hydroxypropyloxypropyl] groups, α,ω-bis[3-(meth)acryloxyethylamino-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxypropylamino-2- α,ω-bis[3-(meth)acryloxybutylamino-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acrylamidoethylamino-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α-terminated polydimethylsiloxane ,ω-bis[3-(meth)acrylamidopropylamino-2-hydroxypropyloxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[3-(meth)acrylamidobutylamino-2-hydroxypropyloxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[( meth)acryloxy-2-hydroxypropyloxyethoxypropyl] groups, α,ω-bis[(meth)acryloxy-2-hydroxypropyl-N-ethylaminopropyl]-terminated polydimethylsiloxane, α,ω-bis[(meth)acryloxy-2-hydroxypropylaminopropyl]polydimethylsiloxane , polydimethylsiloxane with terminal α,ω-bis[(meth)acryloxy-2-hydroxypropyloxy(polyethyleneoxy)propyl] groups, polydimethylsiloxane with terminal α,ω-bis[(meth)acryloxyethylaminocarbonyloxyethoxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[ (meth)acryloxyethylaminocarbonyloxy(polyethyleneoxy)propyl] groups or combinations thereof.

52. An ophthalmic product or method according to any one of embodiments 43-51, wherein the silicone hydrogel material contains repeating units of at least one hydrophilic vinyl monomer.

53. An ophthalmic product or method according to embodiment 52, wherein said at least one hydrophilic vinyl monomer comprises: (1) an alkyl(meth)acrylamide selected from the group consisting of (meth)acrylamide, N,N-dimethyl( meth)acrylamide, N-ethyl(meth)acrylamide, N,N-diethyl(meth)acrylamide, N-propyl(meth)acrylamide, N-isopropyl(meth)acrylamide, N-3-methoxypropyl(meth)acrylamide and combinations thereof ; (2) a hydroxyl-containing acrylic monomer selected from the group consisting of N-2-hydroxyethyl(meth)acrylamide, N,N-bis(hydroxyethyl)(meth)acrylamide, N-3-hydroxypropyl(meth)acrylamide, N-2- hydroxypropyl (meth) acrylamide, N-2,3-dihydroxypropyl (meth) acrylamide,N-tris(hydroxymethyl)methyl(meth)acrylamide, 2-hydroxyethyl(meth)acrylate, 3-hydroxypropyl(meth)acrylate, 2-hydroxypropyl(meth)acrylate, glycerol methacrylate (GMA), di(ethylene glycol)(meth)acrylate, tri(ethylene glycol) (meth) acrylate, tetra (ethylene glycol) (meth) acrylate, poly (ethylene glycol) (meth) acrylate, characterized by a number average molecular weight of not more than 1500, poly (ethylene glycol) ethyl (meth) acrylamide, characterized by a number average molecular weight of not more than 1500, and their combinations; (3) a carboxyl-containing acrylic monomer selected from the group consisting of 2-(meth)acrylamidoglycolic acid, (meth)acrylic acid, ethylacrylic acid, 3-(meth)acrylamidopropionic acid, 5-(meth)acrylamidopentanoic acid, 4-(meth )acrylamidobutanoic acid, 3-(meth)acrylamido-2-methylbutanoic acid, 3-(meth)acrylamido-3-methylbutanoic acid, 2-(meth)acrylamido-2-methyl-3,3-dimethylbutanoic acid, 3-(meth )acrylamidohexanoic acid, 4-(meth)acrylamido-3,3-dimethylhexanoic acid and combinations thereof; (4) an amine-containing acrylic monomer selected from the group consisting of N-2-aminoethyl(meth)acrylamide, N-2-methylaminoethyl(meth)acrylamide, N-2-ethylaminoethyl(meth)acrylamide, N-2-dimethylaminoethyl(meth )acrylamide, N-3-aminopropyl(meth)acrylamide, N-3-methylaminopropyl(meth)acrylamide, N-3-dimethylaminopropyl(meth)acrylamide, 2-aminoethyl(meth)acrylate, 2-methylaminoethyl(meth)acrylate, 2 -ethylaminoethyl(meth)acrylate, 3-aminopropyl(meth)acrylate, 3-methylaminopropyl(meth)acrylate, 3-ethylaminopropyl(meth)acrylate, 3-amino-2-hydroxypropyl(meth)acrylate, trimethylammonium-2-hydroxypropyl( meth)acrylate, dimethylaminoethyl(meth)acrylate, and combinations thereof; (5) N-vinylamide monomer selected from the group consisting of N-vinylpyrrolidone (also known like N-vinyl-2 - pyrrolidone), N-vinyl-3-methyl-2-pyrrolidone, N-vinyl-4-methyl-2-pyrrolidone, N-vinyl-5-methyl-2-pyrrolidone, N-vinyl-6-methyl-2-pyrrolidone , N-vinyl-3-ethyl-2-pyrrolidone, N-vinyl-4,5-dimethyl-2-pyrrolidone, N-vinyl-5,5-dimethyl-2-pyrrolidone, N-vinyl-3,3,5 -trimethyl-2-pyrrolidone, N-vinylpiperidone (also known as N-vinyl-2-piperidone), N-vinyl-3-methyl-2-piperidone, N-vinyl-4-methyl-2-piperidone, N-vinyl-5-methyl-2-piperidone, N-vinyl- 6-methyl-2-piperidone, N-vinyl-6-ethyl-2-piperidone, N-vinyl-3,5-dimethyl-2-piperidone, N-vinyl-4,4-dimethyl-2-piperidone, N- vinylcaprolactam (also known as as N-vinyl-2-caprolactam), N-vinyl-3-methyl-2-caprolactam, N-vinyl-4-methyl-2-caprolactam, N-vinyl-7-methyl-2-caprolactam, N-vinyl- 7-ethyl-2-caprolactam, N-vinyl-3,5-dimethyl-2-caprolactam, N-vinyl-4,6-dimethyl-2-caprolactam, N-vinyl-3,5,7-trimethyl-2- caprolactam, N-vinyl-N-methylacetamide, N-vinylformamide, N-vinylacetamide, N-vinylisopropylamide, N-vinyl-N-ethylacetamide, N-vinyl-N-ethylformamide and mixtures thereof; (6) a methylene-containing pyrrolidone monomer selected from the group consisting of 1-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3-methylene-2-pyrrolidone, 1-methyl-5-methylene-2-pyrrolidone, 1 -ethyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 1-n-propyl-3-methylene-2-pyrrolidone, 1 -n-propyl-5-methylene-2-pyrrolidone, 1-isopropyl-3-methylene-2-pyrrolidone, 1-isopropyl-5-methylene-2-pyrrolidone, 1-n-butyl-3-methylene-2-pyrrolidone , 1-tert-butyl-3-methylene-2-pyrrolidone and combinations thereof; (7) acrylic monomer containing C₁-C₄an alkoxyethoxy group and selected from the group consisting of (meth)acrylate methyl ether ethylene glycol, (meth)acrylate methyl ether di(ethylene glycol), (meth)acrylate methyl ether tri(ethylene glycol), (meth)acrylate methyl ether tetra(ethylene glycol), C₁-C₄alkoxypoly(ethylene glycol)(meth)acrylate having a number average molecular weight of not more than 1500, methoxypoly(ethylene glycol)ethyl(meth)acrylamide having a number average molecular weight of not more than 1500, and combinations thereof; (8) a vinyl ether monomer selected from the group consisting of ethylene glycol monovinyl ether, di(ethylene glycol) monovinyl ether, tri(ethylene glycol) monovinyl ether, tetra(ethylene glycol) monovinyl ether, poly(ethylene glycol) monovinyl ether, ethylene glycol methyl vinyl ether, methyl vinyl ether di(ethylene glycol) ether, tri(ethylene glycol) methyl vinyl ether, tetra(ethylene glycol) methyl vinyl ether, poly(ethylene glycol) methyl vinyl ether, and combinations thereof; (9) an allyl ether monomer selected from the group consisting of ethylene glycol monoallyl ether, di(ethylene glycol) monoallyl ether, tri(ethylene glycol) monoallyl ether, tetra(ethylene glycol) monoallyl ether, poly(ethylene glycol) monoallyl ether, ethylene glycol methylallyl ether, methylallyl di(ethylene glycol) ether, tri(ethylene glycol) methyl allyl ether, tetra(ethylene glycol) methyl allyl ether, poly(ethylene glycol) methyl allyl ether, and combinations thereof; (10) a phosphorylcholine-containing vinyl monomer selected from the group consisting of (meth)acryloyloxyethylphosphorylcholine, (meth)acryloyloxypropylphosphorylcholine, 4-((meth)acryloyloxy)butyl-2'-(trimethylammonio)ethyl phosphate, 2-[(meth)acryloylamino]ethyl -2'-(trimethylammonio)ethyl phosphate, 3-[(meth)acryloylamino]propyl-2'-(trimethylammonio)ethylphosphate, 4-[(meth)acryloylamino]butyl-2'-(trimethylammonio)ethylphosphate, 5-((meth )acryloyloxy)pentyl-2'-(trimethylammonio)ethyl phosphate, 6-((meth)acryloyloxy)hexyl-2'-(trimethylammonio)ethylphosphate, 2-((meth)acryloyloxy)ethyl-2'-(triethylammonio)ethylphosphate, 2 -((meth)acryloyloxy)ethyl-2'-(tripropylammonio)ethyl phosphate, 2-((meth)acryloyloxy)ethyl-2'-(tributylammonio)ethylphosphate, 2-((meth)acryloyloxy)propyl-2'-(trimethylammonio )ethyl phosphate, 2-((meth)acryloyloxy)butyl-2'-(trimethylammonio)ethylphosphate, 2-((meth)acryloyloxy)pentyl-2'-(trimethylammonio)ethylphosphate, 2-((meth)acryloyloxy)hexyl-2 '-(trimethylammonio)ethyl phosphate, 2-(vinyloxy)ethyl-2'-(trimethylammonio)ethylphosphate, 2-(allyloxy)ethyl-2'-(trimethylammonio)ethylphosphate, 2-(vinyloxycarbonyl)ethyl-2'-(trimethylammonio) ethyl phosphate, 2-(allyloxycarbonyl)ethyl-2'-(trimethylammonio)ethylphosphate, 2-(vinylcarbonylamino)ethyl-2'-(trimethylammonio)ethylphosphate, 2-(allyloxycarbonylamino)ethyl-2'-(trimethylammonio)ethylphosphate, 2-( butenoyloxy)ethyl-2'-(trimethylammonio)ethyl phosphate and combinations thereof; (11) allyl alcohol; (12) N-2-hydroxyethyl vinyl carbamate; (13) N-carboxyvinyl-β-alanine (VINAL); (14) N-carboxyvinyl-α-alanine (15) or combinations thereof.

54. An ophthalmic product or method according to embodiment 52 or 53, wherein said at least one hydrophilic vinyl monomer comprises N-vinylpyrrolidone, N-vinyl-N-methylacetamide, or combinations thereof.

55. An ophthalmic product or method according to any one of embodiments 52-54, wherein said at least one hydrophilic vinyl monomer comprises N,N-dimethyl(meth)acrylamide.

56. An ophthalmic product or method according to any one of embodiments 52-55, wherein said at least one hydrophilic vinyl monomer comprises N-2-hydroxyethyl(meth)acrylamide, NN-bis(hydroxyethyl)(meth)acrylamide, N- 3-hydroxypropyl(meth)acrylamide, N-2-hydroxypropyl(meth)acrylamide, N-2,3-dihydroxypropyl(meth)acrylamide, N -tris(hydroxymethyl)methyl(meth)acrylamide, 2-hydroxyethyl(meth)acrylate, 3-hydroxypropyl(meth)acrylate, 2-hydroxypropyl(meth)acrylate, glycerol methacrylate (GMA), di(ethylene glycol)(meth)acrylate, tri(ethylene glycol)(meth)acrylate, tetra(ethylene glycol)(meth)acrylate, poly (ethylene glycol)(meth)acrylate having a number average molecular weight of not more than 1500, poly(ethylene glycol)ethyl(meth)acrylamide having a number average molecular weight of not more than 1500, or combinations thereof.

57. An ophthalmic product or method according to any one of embodiments 43-56, wherein the silicone hydrogel material contains repeating units of at least one crosslinker other than siloxane-vinyl.

58. An ophthalmic product or method according to Embodiment 57, wherein said at least one crosslinker other than siloxane-vinyl comprises ethylene glycol di(meth)acrylate, diethylene glycol di(meth)acrylate, triethylene glycol di(meth)acrylate, tetraethylene glycol di( meth)acrylate, glycerol di(meth)acrylate, 1,3-propanedioldi(meth)acrylate, 1,3-butanedioldi(meth)acrylate, 1,4-butanedioldi(meth)acrylate, glycerol-1,3-diglycerolatedi(meth) )acrylate, ethylenebis[oxy(2-hydroxypropan-1,3-diyl)]di(meth)acrylate, bis[2-(meth)acryloxyethyl]phosphate, trimethylolpropane di(meth)acrylate and 3,4-bis[(meth) acryloyl]tetrahydrofuran, diacrylamide, dimethacrylamide, N,N-di(meth)acryloyl-N-methylamine, N,N-di(meth)acryloyl-N-ethylamine, N,N'-methylenebis(meth)acrylamide, N, N '-ethylenebis(meth)acrylamide, N,N'-dihydroxyethylenebis(meth)acrylamide, N,N'-propylenebis(meth)acrylamide, N,N'-2-hydroxypropylenebis(meth)acrylamide, N,N'-2, 3-dihydroxybutylenebis(meth)acrylamide, 1,3-bis(meth)acrylamidepropan-2-yldihydrophosphate, piperazine diacrylamide, tetraethylene glycol divinyl ether, triethylene glycol divinyl ether, diethylene glycol divinyl ether, ethylene glycol divinyl ether, triallyl isocyanurate, triallyl cyanurate, trimethylpropane trimethacrylate, pentaerythritol tetramethacrylate, bisphenol dimethacrylate A, allyl methacrylate, allyl acrylate, N-allyl methacrylamide, N-allyl acrylamide, or combinations thereof.

59. An ophthalmic product or method according to any one of embodiments 43-58, wherein the silicone hydrogel material contains repeating units of at least one miscible vinyl monomer.

60. An ophthalmic product or method according to any one of embodiments 43-58, wherein said at least one miscible vinyl monomer comprises C ₁ -C ₁₀ alkyl (meth) acrylate, cyclopentyl acrylate, cyclohexyl methacrylate, cyclohexyl acrylate, isobornyl (meth) acrylate, styrene, 4,6-trimethylstyrene (TMS), tert-butylstyrene (TBS), trifluoroethyl(meth)acrylate, hexafluoroisopropyl(meth)acrylate, hexafluorobutyl(meth)acrylate, or combinations thereof.

61. An ophthalmic product or method according to any one of embodiments 43-58, wherein said at least one miscible vinyl monomer comprises methyl methacrylate.

62. The ophthalmic product or method according to any one of embodiments 43-61, wherein the silicone hydrogel material comprises repeat units of at least one UV absorbing vinyl monomer and/or repeat units of at least one UV/HEVL absorbent vinyl monomer .

63. An ophthalmic product or method according to any one of embodiments 43-61, wherein the silicone hydrogel material contains repeat units of 2-[2'-hydroxy-5'-(2-methacryloxyethyl)phenyl)]-2H-benzotriazole (Norbloc ) and repeating units of at least one UV/HEVL absorbing vinyl monomer which is 2-{2'-hydroxy-3'- tert -butyl-5'-[3'-methacryloyloxypropoxy]phenyl} -2H -benzotriazole, 2-{2'-hydroxy-3'- tert -butyl-5'-[3'-methacryloyloxypropoxy]phenyl}-5-methoxy- 2H -benzotriazole (UV13), 2-{2'-hydroxy-3'- tert -butyl-5'-[3'-methacryloyloxypropoxy]phenyl}-5-chloro -2H -benzotriazole (UV28), 2-[2'-hydroxy-3'- tert -butyl-5'-(3'-acryloyloxypropoxy) phenyl]-5-trifluoromethyl -2H -benzotriazole (UV23) or combinations thereof.

64. An ophthalmic product or method according to any of Embodiments 1 and 3-63 or a method according to any of Embodiments 3-63, wherein the easy-to-use silicone hydrogel contact lens has a UV-B transmittance of approximately 10 % or less in the wavelength range of 280 to 315 nm, a UV-A transmittance of about 30% or less in the wavelength range of 315 to 380 nm, and a violet transmittance of about 70% or less, preferably about 60% or less, more preferably about 50% or less, even more preferably about 40% or less in the wavelength range from 380 nm to 440 nm.

65. The ophthalmic product or method of Embodiment 64, wherein the easy-to-use silicone hydrogel contact lens has a UV-B transmittance of about 5% or less in the wavelength range of 280 to 315 nm.

66. The ophthalmic product or method of Embodiment 63, wherein the easy-to-use silicone hydrogel contact lens has a UV-B transmittance of about 2.5% or less in the wavelength range of 280 to 315 nm.

67. The ophthalmic product or method of Embodiment 64, wherein the easy-to-use silicone hydrogel contact lens has a UV-B transmittance of about 1% or less in the wavelength range of 280 to 315 nm.

68. An ophthalmic product or method according to any one of embodiments 64-67, wherein the easy-to-use silicone hydrogel contact lens has a UV-A transmittance of about 20% or less in the wavelength range of 315 to 380 nm.

69. An ophthalmic product or method according to any one of embodiments 64-67, wherein the easy-to-use silicone hydrogel contact lens has a UV-A transmittance of about 10% or less in the wavelength range of 315 to 380 nm.

70. An ophthalmic product or method according to any one of embodiments 64-67, wherein the easy-to-use silicone hydrogel contact lens has a UV-A transmittance of about 5% or less in the wavelength range of 315 to 380 nm.

71. An ophthalmic product or method according to any one of embodiments 64-67, wherein the easy-to-use silicone hydrogel contact lens has a violet transmittance of about 60% or less in the wavelength range of 380 nm to 440 nm.

72. An ophthalmic product or method according to any of embodiments 64-67, wherein the easy-to-use silicone hydrogel contact lens has a violet transmittance of about 50% or less in the wavelength range of 380 nm to 440 nm.

73. An ophthalmic product or method according to any one of embodiments 64-67, wherein the easy-to-use silicone hydrogel contact lens has a violet transmittance of about 40% or less in the wavelength range of 380 nm to 440 nm.

74. An ophthalmic product according to any of Embodiments 1 and 3-73, or a method according to any of Embodiments 2-73, wherein the static water contact angle of an easy-to-use silicone hydrogel contact lens immediately after opening is sealed and sterilized in autoclaved packaging at least 10 degrees lower than the static water contact angle of a preformed silicone hydrogel contact lens.

75. An ophthalmic product according to any of Embodiments 1 and 3-73 or a method according to any of Embodiments 2-73, wherein the static water contact angle of an easy-to-use silicone hydrogel contact lens immediately after opening is sealed and sterilized in autoclaved packaging at least 15 degrees lower than the static water contact angle of a preformed silicone hydrogel contact lens.

76. An ophthalmic product according to any of Embodiments 1 and 3-73 or a method according to any of Embodiments 2-73, wherein the static water contact angle of an easy-to-use silicone hydrogel contact lens immediately after opening is sealed and sterilized in autoclaved packaging at least 20 degrees lower than the static water contact angle of a preformed silicone hydrogel contact lens.

77. An ophthalmic product according to any of Embodiments 1 and 3-76, or a method according to any of Embodiments 2-76, wherein the polymeric surfactant is present in the packaging solution prior to autoclaving in an amount selected to provide a difference less than about 0.20 mm in lens diameter between an easy-to-use SiHy contact lens and a control lens, which is a preformed SiHy contact lens autoclaved in PBS containing no polymeric surfactant, of less than about 0.20 mm.

78. The ophthalmic product according to any of embodiments 1 and 3-76 or the method according to any of embodiments 2-76, wherein the polymeric surfactant is present in the packaging solution prior to autoclaving in an amount selected to provide a difference less than about 0.17 mm in lens diameter between an easy-to-use SiHy contact lens and a control lens, which is a preformed SiHy contact lens autoclaved in PBS containing no polymeric surfactant, of less than about 0.17 mm.

79. An ophthalmic product according to any of Embodiments 1 and 3-76, or a method according to any of Embodiments 2-76, wherein the polymeric surfactant is present in the packaging solution prior to autoclaving in an amount selected to provide a difference less than about 0.15 mm in lens diameter between an easy-to-use SiHy contact lens and a control lens, which is a preformed SiHy contact lens autoclaved in PBS containing no polymeric surfactant, of less than about 0.15 mm.

80. An ophthalmic product according to any of Embodiments 1 and 3-76, or a method according to any of Embodiments 2-76, wherein the polymeric surfactant is present in the packaging solution prior to autoclaving in an amount selected to provide a difference less than about 0.12 mm in lens diameter between an easy-to-use SiHy contact lens and a control lens, which is a preformed SiHy contact lens autoclaved in PBS containing no polymeric surfactant, of less than about 0.12 mm.

81. The method according to any one of embodiments 2-80, or the ophthalmic product according to any one of embodiments 1 and 3-80, wherein the packaging solution prior to autoclaving contains from about 0.005% to about 0.038% by weight of the polymeric surfactant. active substance.

82. The method according to any one of embodiments 2-80, or the ophthalmic product according to any one of embodiments 1 and 3-80, wherein the packaging solution prior to autoclaving contains from about 0.007% to about 0.036% by weight of the polymeric surfactant. active substance.

83. The method according to any of embodiments 2-80 or the ophthalmic product according to any of embodiments 1 and 3-80, wherein the packaging solution prior to autoclaving contains from about 0.008% to 0.034% by weight of the polymeric surfactant substances.

84. The method according to any of embodiments 2-80 or the ophthalmic product according to any of embodiments 1 and 3-80, wherein the packaging solution prior to autoclaving contains from about 0.009% to 0.032% by weight of the polymeric surfactant substances.

85. The method according to any of embodiments 2-80, or the ophthalmic product according to any of embodiments 1 and 3-80, wherein the packaging solution prior to autoclaving contains from about 0.010% to 0.030% by weight of the polymeric surfactant substances.

86. The method according to any one of embodiments 2-85 or the ophthalmic product according to any one of embodiments 1 and 3-85, wherein the sealed package containing the preformed silicone hydrogel contact lens is autoclaved for at least about at least 45 minutes.

The above disclosure will make it easier for a person skilled in the art to practice the present invention. Various modifications, variations, and combinations may be made in the various embodiments described herein. To better ensure the reader's understanding of specific embodiments and their advantages, reference is made to the following examples. The description and examples are intended to be considered illustrative.

Example 1

Measurement of oxygen permeability

Unless otherwise specified, the oxygen transmission coefficient (Dk/t), intrinsic (or edge-corrected) oxygen permeability (Dk _i or Dk _c ) of the lens and lens material are determined according to the procedures described in ISO 18369-4.

Surface wettability test

The water contact angle (WCA) on a contact lens is a general measure of the wettability of a contact lens surface. In particular, a small contact angle with water corresponds to a more wettable surface. The average contact angle values (by the sessile drop method) of contact lenses are measured using a VCA 2500 XE contact angle measuring device from AST, Inc., located in Boston, Massachusetts. This equipment is capable of measuring advancing contact angles (θ _a ), or receding contact angles (θ _r) , or fixed (static) contact angles. Unless otherwise stated, the water contact angle is the fixed (static) contact angle on the front surface of the contact lens. Measurements are taken on fully hydrated contact lenses and immediately after drying by blotting. The wet-dried lens is then placed on the contact angle measurement stand with the front face up, and the contact angle of the sessile drop is automatically measured using software provided by the manufacturer. The deionized water (ultrapure) used to measure the angle of contact with water has a resistivity of more than 18 MΩcm, and the drop volume used is 2 μL. Before bringing into contact with contact lenses, the tweezers and the holder are rinsed well with isopropanol and rinsed with DI water. Each static water contact angle is the average of the left and right water contact angles. The static water contact angle with respect to a contact lens is the average water contact angle obtained by averaging the static water contact angles measured for at least 5 contact lenses.

Water Film Break Time Test (WBUT)

The hydrophilicity of the lens surface (after autoclaving) was assessed by determining the time that elapses before the onset of rupture of the aqueous film on the lens surface. Lenses with a WBUT ≥ 5 seconds are considered to have a hydrophilic surface and are expected to be sufficiently wetting (capable of supporting a tear film) on the eye.

Lenses are prepared for aqueous film break measurement by removing the lens from the blister (or container) using soft plastic tweezers (Menicon) and placing the lens in a beaker containing phosphate buffered saline. The beaker contains at least 20 ml of phosphate buffered saline per lens, with no more than 3 lenses per beaker. Lenses are soaked for a minimum of 30 minutes and no more than 24 hours, after which, using soft plastic tweezers, they are transferred to a 96-well plastic tray with fresh phosphate buffered saline.

The time to break of the aqueous film is measured at room temperature as follows: the lenses are taken with soft plastic tweezers as close as possible to the edge of the lens, with the back curved surface towards the measuring device, making sure that the lens does not touch the walls of the well after removal from the saline solution. As shown schematically in FIG. 1, the lens (101) is shaken once to remove excess saline and a timer is started. Ideally, the water film (120) on the rear curved surface of the lens will move away from the point of contact with the tips (111) of the tweezers, forming a uniform circular pattern (125). The timer is stopped when approximately 30% of the hydrated area (125) is removed from the point of contact, and this time is recorded as the time to break of the water film (WBUT). Lenses that do not show a perfect receding pattern can be placed back in the tray and re-measured after rehydration for at least 30 seconds.

Equilibrium moisture content

The equilibrium moisture content (EWC) of contact lenses is determined as follows.

The moisture content (expressed as a mass percentage) of a hydrated hydrogel contact lens fully equilibrated in saline is determined at room temperature. The lenses are quickly stacked and the stack of lenses is transferred to an aluminum pan on an analytical balance after blotting the lenses with a cloth. The number of lenses in each sample dish is typically five (5). The weight of the hydrated lens dish is recorded. The dish is covered with aluminum foil. The cups are placed in a laboratory oven at 100±2°C to dry for 16-18 hours. The cup with lenses is removed from the heating cabinet and cooled in a desiccator for at least 30 minutes. Remove the cups one at a time from the desiccator and remove the aluminum foil. The cup with dried lenses is weighed on an analytical balance. Repeat this operation with all cups. Wet and dry weights of lens samples can be calculated by subtracting the empty cup weights.

Elastic modulus

The modulus of elasticity of a contact lens is determined using the MTS insight instrument. The contact lens is first cut into a 3.12 mm wide strip using a Precision Concept two stage cutter. Five thicknesses are measured within a reference length of 6.5 mm. Attach the strip to the grips of the instrument and immerse in PBS (phosphate buffered saline) at a controlled temperature of 21 ± 2°C. Typically, a 5H strain gauge is used for testing. A constant load and a loading rate are applied to the sample until the sample fails. Force and strain are recorded using the TestWorks software. The value of the modulus of elasticity is calculated using the TestWorks software from the slope or tangent of the load-stress curve at a point with near-zero elongation in the region of elastic deformation.

Transmittance

Contact lenses are manually placed in a specially made sample holder or similar device that can retain the shape of the lens as it would be when placed on the eye. This holder is then immersed in a 1 cm path length quartz cuvette containing phosphate buffered saline (PBS, pH～7.0-7.4) as a reference. For this measurement, a UV/visible spectrophotometer such as a Varian Cary 3E UV/visible spectrophotometer equipped with a LabSphere DRA-CA-302 beam splitter or similar can be used. , while the %T values are recorded at intervals of 0.5 nm. This data is transferred to an Excel spreadsheet and used to determine the UV class 1 lens compliance. The transmittance is calculated using the following formulas:

Determining the Diameter of a Hydrated Contact Lens

In FIG. 2 schematically shows the general dimensions of the lens, which are usually determined by the manufacturer of contact lenses. General measurements include center thickness (CT) ( 210 ), anterior sagittal height (ASag) ( 220 ), posterior sagittal height (PSag) ( 240 ), posterior curved surface equivalent (BCE) ( 250 ), marginal thickness (ET ) ( 260 ) and diameter ( 280 ). Measurements of overall lens dimensions can be made on fully hydrated wet cell contact lenses using a low coherence interferometer similar to that described by Heidemana and Greivenkampin in their article (Optical Engineering 55(3), 034106 (March 2016)).

For measurements, a contact lens is placed on the flat bottom surface of a wet cell that is filled with phosphate buffered saline, and a low coherence interferometer is placed at the geometric center of the lens using a motion controller. The interferometer measures the thickness of a material based on reflections between different surfaces of the material. The center of the lens is determined by camera measurement.

Diameter is defined as the most protruding edge of a lens when viewed from above the lens. The edge points correspond to an ellipse, and the diameter is calculated as the average of the large and small diameters of the ellipse. Typically, contact lenses are characterized by very round diameters, and a round or elliptical fit results in similar values. However, if the shape of the lens is slightly out of round, the ellipse more accurately describes the shape of the contact lens diameter than the circle. Measure from 3 to 10 contact lenses from one lot of contact lenses and average their lens diameters to obtain the average lens diameter for this lot of contact lenses.

7 extraction cycles while simulating 1-day wear

Seven extraction cycles in simulated 1-day wear (S1DW extraction) were performed as follows. In the 1st S1DW extraction cycle, one to three easy-to-use SiHy contact lenses are removed from sealed packs and blotted; all soaked easy-to-use SiHy contact lenses are soaked together in 1.0 ml of fresh phosphate buffered saline (PBS) as extraction medium in one vial, which is kept with shaking in a water bath at 35ºC for 24 hours; and then all of the PBS used in the 1st S1DW extraction cycle is pipetted from the vial and stored for later analysis by UPLC (Ultra High Performance Liquid Chromatography). In S1DW extraction cycles from the 2nd on the 7th to a vial containing easy-to-use SiHy contact lenses that have been subjected to a previous S1DW extraction cycle, add 1.0 ml of fresh PBS as extraction medium; easy-to-use SiHy contact lenses are soaked together in the added 1.0 ml of fresh PBS in a vial kept with shaking in a water bath at 35^oC within 24 hours; and then all PBS used in the current S1DW extraction run is pipetted from the vial and stored for later analysis by UPLC.

Chemical substances

The following abbreviations are used in the following examples: TFA stands for trifluoroacetic acid; UPW means ultrapure water with a resistivity greater than 18 MΩcm; UPLC stands for Ultra High Performance Liquid Chromatography; NVP means N-vinylpyrrolidone; MMA means methyl methacrylate; TEGDMA means triethylene glycol dimethacrylate; VAZO 64 means 2,2'-dimethyl-2,2'-azodipropiononitrile; Norbloc is 2-[3-(2H-benzotriazol-2-yl)-4-hydroxyphenyl]ethyl methacrylate available from Aldrich; UV28 is 2-{2'-hydroxy-3'- tert -butyl-5'-[3'-methacryloyloxypropoxy]phenyl}-5-chloro- 2H -benzotriazole; RB247 is Reactive Blue 247; TAA means tert-amyl alcohol; PrOH means 1-propanol; IPA means isopropanol; PBS means phosphate-buffered saline solution, which is characterized by a pH of 7.2±0.2 at 25 ^o C and contains approximately 0.077 wt. % NaH ₂ PO ₄ ·H ₂ O, approximately 0.31 wt. % Na ₂ HPO ₄ ·2H ₂ O and approximately 0.77 wt. % NaCl, and; weight. % means weight percent; D9 is a monobutyl and monomethacryloxypropyl terminated polydimethylsiloxane (Mw ~ 984 g/mol, provided by Shin-Etsu); macromer "G4" is a dimethacryloyloxypropyl terminated polysiloxane (Mn ~ 13.5 thousand g/mol, OH content ~ 1.8 meq/g) of formula (A).

Example 2

Preparation of polymerizable compositions

Lens compositions (polymerizable compositions) I-IV are prepared to obtain compositions (in proportions) as shown in Table 1.

Table 1

Composition I Composition II Composition III Composition IV D9 33 33 33 33 G4 10 10 10 10 NVP 46 46 46 46 MMA 10 10 10 10 TEGDMA 0.2 0.2 0.2 0.65 Norbloc 1.5 1.5 1.8 1.5 UV28 0.26 0.26 0 0.4 VAZO 64 0.5 0.5 0.5 0.5 RB247 0.01 0.01 0.01 0.01 TAA 10 10 10 10 curing mode 55/80/100 ^o C 30 min./
2 hours/30 minutes 55/80/ ^100oC
40 min./
40 min./
40 min. 55/80/ ^100oC
30 min./
120 min./
30 min. 55/80/ ^100oC
30 min./
120 min./
30 min.

Formulations are prepared by adding the listed components in their intended amounts to a clean vessel with a stirrer at 600 rpm. for 30 minutes at room temperature. After all solids have dissolved, the composition is filtered using a glass microfiber filter with a pore size of 2.7 μm.

Cast SiHy contact lenses

The lens composition is purged with nitrogen at room temperature for 30-35 minutes. The N ₂ purged lens composition is injected into polypropylene molds and thermally cured in a heating cabinet under the following curing conditions: raising the temperature from room temperature to a first temperature and then holding at the first temperature for a first curing time period; smoothly changing the temperature from the first to the second temperature and keeping at the second temperature during the second curing time period; optionally raising the temperature from the second to the third temperature and holding at the third temperature for a third curing time period; and optionally raising the temperature from the third to the fourth temperature and holding at the fourth temperature for a fourth curing time period.

Lens molds are opened with a press pin mold opener. The lenses are pressed into the back curve molds with a push pin and then the molds are separated into back curve halves and front curve halves. The halves of the shape of the rear curved surface with the lens on it are placed in an ultrasonic device (eg Dukane single waveguide ultrasonicator). A dry lens is removed from the mold by applying a certain energy force. The dry lens is loaded into a tray specially designed for extraction. Alternatively, the lenses can be removed from the halves of the posterior curved surface mold by floating (i.e., soaking in an organic solvent, such as IPA, without ultrasonication).

After opening the molds, cast SiHy contact lenses are extracted with PrOH for 180 minutes to extract the lens, washed in water (55/45) for approximately 25 minutes, rinsed with PB (phosphate buffer containing approximately 0.077 wt.% NaH ₂ PO ₄ ·H ₂ O and approximately 0.31 wt.% Na ₂ HPO ₄ ·2H ₂ O) for approximately 50-60 minutes, and then packed/sealed in polypropylene (PP) packaging shells (blisters) for lenses with 0 .65 ml of packaging solution as described in the following examples. Sealed lens packages are autoclaved at approximately 121 ^° C. for approximately 45 minutes. The resulting SiHy contact lenses are characterized according to the procedures for the following properties: Dkc ~ 105 barrer - 118 barrer; EWC ~ 54% - 57%; modulus of elasticity ~ 0.45 MPa - 0.62 MPa; WBUT ~ 23 seconds to 40 seconds ; contact angle with water according to the sticking bubble method ~ 47 ^o - 52 ^o , friction coefficient of approximately 2.0.

The following examples use SiHy contact lenses prepared from Formulation IV unless otherwise noted.

Example 3

Preparation of packaging solutions

Copolymer 845 is a copolymer of N-vinylpyrrolidone and dimethylaminoethyl methacrylate (M _w ~ 700,000-1,200,000 g/mol according to GPC against polyethylene oxide standards, M _w /M _n ~ 5.7-8.5) and obtained from ISP.

PEO-PBO block copolymer ("EO ₄₅ BO ₁₀ ") of formula (S2), wherein R is methyl, m has an average value of 45; and n has an average value of 10, obtained in accordance with the procedures described in US8318144. This polymeric surfactant has an HLB of approximately 14.7 calculated from the formula is the molecular weight of the EO ₄₅ BO ₁₀ copolymer.

Prepare four packaging solutions by dissolving the various components in 1 liter of water as shown in Table 2. Concentrations are given in weight percent.

table 2

Packing Solution No. I II III IV NaCl (% by weight) 0.77 0.77 0.77 0.77 NaH ₂ PO ₄ •H ₂ O (% by weight) 0.076 0.076 0.076 0.076 Na ₂ HPO ₄ •7H ₂ O (% by weight) 0.47 0.47 0.47 0.47 Copolymer 845 (% by weight) 0 1.0 0 1.0 CH ₃ O(EO) ₄₅ (BO) ₁₀ 0 0 0.015 0.015

Lens packaging

The SiHy contact lenses prepared in Example 2 were individually packaged and sealed in PP blister packs each containing 0.65 ml of a packaging solution (one of the packaging solutions I-IV obtained above). Sealed lens packages are autoclaved at approximately 121 ^° C. for 45 minutes.

Wettability of easy-to-use SiHy contact lenses

Static water contact angles (WCA _OOP ) of easy-to-use SiHy contact lenses immediately after opening the packages after storage at room temperature for approximately 12 months are determined in accordance with the procedures described in example 1. The results are shown in table 3.

Table 3

Packing Solution No. I II III IV WCA _OOP (degrees) 75±5 67 ± 3 42±5 36±3

Table 3 shows that the wettability of easy-to-use SiHy lenses that were packaged and autoclaved in a packaging solution containing a polymeric surfactant (EO ₄₅ BO ₁₀ ) and stored at room temperature for approximately 12 months improved significantly. compared to easy-to-use SiHy lenses packed in a packaging solution containing no EO ₄₅ BO ₁₀ (packing solution I as control) (i.e. corresponding to the original preformed SiHy contact lens) and that the combination of EO ₄₅ BO ₁₀ with high molecular weight hydrophilic polymer (copolymer 845) may have some synergy, reducing water contact angles (i.e. increasing wettability) of easy-to-use SiHy lenses packaged in a packaging solution containing a mixture of EO ₄₅ BO ₁₀ and copolymer 845, even although Copolymer 845 alone may slightly increase the wettability of easy-to-use SiHy lenses packaged in a packaging solution containing Copolymer 845.

Example 4

The duration of availability of a polymeric surfactant in an easy-to-handle SiHy contact lens is evaluated using a fluorescently labeled polymeric surfactant (NBD-labeled EO ₄₅ BO ₁₀ , in which NBD is nitrobenzoxadiazole and EO ₄₅ BO ₁₀ is a block PEO-PBO copolymer of formula (S2) wherein R is methyl, m has an average value of 45, and n has an average value of 10 (denoted as EO ₄₅ BO ₁₀ ). polymeric surfactant in a contact lens and demonstrates that the polymeric surfactant is still present after 7 extraction cycles with simulated 1-day wear and cleaning (i.e., simulated 7 days of daily wear and standard cleaning).

Synthesis of NBD-EO ₄₅ BO ₁₀

NBD-EO ₄₅ BO ₁₀ receive in accordance with the following scheme.

100 mg of NBD-COCl (4-( N -chloroformylmethyl- N -methylamino)-7-nitro-2,1,3-benzoxadiazole) are dissolved in 0.5 ml of hexane and 2.5 ml of methylene chloride. Then add ~1 g of EO ₄₅ BO ₁₀ (Mn ~3000 g/mol) and 0.7 g of dry K ₂ CO ₃ . The reaction is carried out under N ₂ for more than 48 hours at room temperature. The K ₂ CO ₃ is centrifuged and the solvent is evaporated off. Purification of NBD-EO ₄₅ BO ₁₀ is carried out using dialysis or a SEC column. Further purification by collecting fractions on an HPLC column is carried out to obtain high purity NBD-EO ₄₅ BO ₁₀ (99.5 wt.%).

This NBD-labeled polymeric surfactant has an HLB of approximately 13.4 calculated from the formula

is the molecular weight of the NBD-labeled copolymer NBD-EO ₄₅ BO ₁₀ .

Getting the packaging solution

A packaging solution is prepared by dissolving the purified NBD-EO ₄₅ BO ₁₀ obtained above, copolymer 845 and other necessary components in water to obtain the following composition: 150 ppm NBD-EO ₄₅ BO ₁₀ , 1% by weight of copolymer 845, 0.77% by NaCl, 0.076% by weight NaH ₂ PO ₄ •H ₂ O and 0.47% by weight Na ₂ HPO ₄ •7H ₂ O.

Lens packaging

SiHy contact lenses prepared according to the procedures described in Example 2 are individually packaged and sealed in PP blister packs, each containing 0.65 ml of prepared packaging solution. Sealed lens packages are autoclaved at approximately 121 ^° C. for 45 minutes.

Absorption of NBD-EO ₄₅ BO ₁₀

The concentrations of NBD-EO ₄₅ BO ₁₀ in the packaging solution before and after autoclaving are measured using the HPLC method.

Analysis of NBD-EO ₄₅ BO ₁₀ in packaging solution is performed using a UPLC Waters reverse phase system equipped with a fluorescence detector and UPLC 150 mm X diameter 2.1 mm columns with a particle size of 1.9 µm (for example, ThermoScientific Hypersil GOLD or etc.). The mobile phase is prepared as a mixture of mobile phase: A - 50:30:19.8:0.2 (v/v) methanol/acetonitrile/water/formic acid, and mobile phase: B - 59.8:40: 0.2 (v/v) methanol/acetone/formic acid. The mobile phase is filtered through a 0.45 µm nylon filter. The flow rate is 0.3 ml per minute. The column temperature is set at 60° C. with an analysis time of 30 minutes. Fluorescent NBD-EO ₄₅ BO ₁₀ (λ excitation=460 nm; λ emission=510 nm) is detected in the retention time (RT) range from 4 min. to RT 12 min.

The amount of NBD-EO ₄₅ BO ₁₀ absorbed by an easy-to-use SiHy contact lens is calculated as (C _{before autoclaving} - C _{after autoclaving} )*0.65 ml. Five easy-to-use lenses are used to obtain an average amount of NBD-EO ₄₅ BO ₁₀ absorbed by an easy-to-use SiHy contact lens. The absorbed amount of NBD-EO ₄₅ BO ₁₀ was found to be approximately 100 μg/lens.

Also, the amount of NBD-EO ₄₅ BO ₁₀ absorbed by an easy-to-use SiHy contact lens can be determined by fully extracting it with acetone/hexane 1:1 as the extraction medium and determining the amount of NBD-EO ₄₅ BO ₁₀ in the extraction medium. Similarly, five easy-to-use lenses are used to obtain an average amount of NBD-EO ₄₅ BO ₁₀ absorbed by an easy-to-use SiHy contact lens.

Visualization of NBD-EO absorption ₄₅ BO ₁₀

NBD-EO ₄₅ BO ₁₀ absorbed by an easy-to-use SiHy contact lens is visualized using confocal microscopy. As a control, SiHy contact lenses immersed in the packaging solution without the autoclaving step were also examined by confocal microscopy. It is noted that when examining SiHy contact lenses autoclaved in PBS (not containing NBD-EO ₄₅ BO ₁₀ ), there is no fluorescence that serves as background fluorescence.

Easy-to-use SiHy contact lenses and control lenses are orthogonally cut to obtain transverse sections and visualized using a Nikon fluorescence microscope. For excitation of NBD-EO ₄₅ BO ₁₀ choose a laser with a wavelength of 488 nm. For this experiment, a magnification of 63x is used, and the scale bar is 50 µm. Fluorescence cross-sectional images of easy-to-use SiHy contact lenses show that NBD-EO ₄₅ BO ₁₀ is adsorbed on the lens surface and penetrates deeply into the bulk material of easy-to-use SiHy contact lenses (FIG. 3A). In comparison, cross-sectional fluorescence images of NBD-EO ₄₅ BO ₁₀ control contact lenses show that NBD-EO ₄₅ BO ₁₀ is mainly adsorbed on the lens surface and penetrates into the bulk material in the surface region of the contact lenses (FIG. 4A). Data obtained using line scan confocal microscopy (FIGS. 3B and 4B) confirm visual observations.

These experiments show that a significant amount of NBD-EO ₄₅ BO ₁₀ is located on the surface and near the surface, and that the autoclaving step is important to incorporate the polymeric surfactant deep into the SiHy contact lens.

7 extraction cycles while simulating 1-day wear and cleaning

7 cycles of extraction in simulated 1-day wear and cleaning (S1DWC extractions) were carried out as follows. In the first cycle, each lens is removed from the sealed package, blotted and then soaked in 1 ml of fresh PBS in a vial that is kept with shaking in a water bath at 35°C for 8 hours; and after 8 hours of soaking, the lens is gently blotted and soaked in 2 ml of fresh Opti-Free Replenish (OFR) solution in a vial for 16 hours at room temperature. In the second cycle, the lens is removed from the OFR solution used in the 1st cycle, again gently blot and soak in 1 ml of fresh PBS in a vial, which is kept with shaking in a water bath at 35°C for 8 hours; and after 8 hours of soaking, the lens is gently blotted and soaked in 2 ml of fresh OFR solution in a vial for 16 hours at room temperature. In cycles with 3rd to 6th extraction is carried out similarly to the 2nd cycle. In the 7th cycle, the lens is removed from the OFR solution used in the 6th cycle, again gently blot and soak in 1 ml of fresh PBS in a vial, which is kept with shaking in a water bath at 35°C for 8 hours. For the 7th cycle soaking in the OFR solution is not carried out.

All PBS and OFR solutions, after soaking, are stored in a freezer until introduced into the HPLC system.

It should be noted that the step of soaking one SiHy contact lens in 1 ml of fresh PBS at 35 ^° C for 8 hours is intended to simulate the patient's normal daily wearing of a contact lens on the eye (approximately 8 hours), while the step of soaking one SiHy contact lens in 2 ml OFR is intended to mimic the patient's standard practice in accordance with normal lens care regimens.

Autoclaved NBD-EO ₄₅ BO ₁₀ lenses were butterfly cut and visualized using a conventional Nikon microscope at time 0 and after 7 extraction cycles with simulated 1 day wear and cleaning. The amount of fluorescence was evaluated by integration using ImageJ image analysis software, and the results show that after 7 days, the contact lens still retains approximately at least 70% fluorescence.

Table 4 shows the results of the release of NBD-EO ₄₅ BO ₁₀ into each of the extraction media determined using the HPLC method as described above.

Table 4

Number of NBD-EOs ₄₅ BO ₁₀ released per lens (mcg) Lens 1 Lens 2 Lens 3 In PBS IN OFR In PBS IN OFR In PBS IN OFR 1st cycle 5.3 1.9 3.4 2.0 4.9 2.0 2nd cycle 4.6 1.2 4.7 1.3 5.2 1.2 3rd cycle 4.5 1.4 3.8 1.4 4.5 1.4 4th cycle 3.6 1.7 4.3 1.3 3.2 0.9 5th cycle 4.1 1.1 3.8 1.2 4.5 1.1 6th cycle 3.9 1.0 4.0 0.9 3.9 0.8 7th cycle 3.1 3.1 3.9 Total amount released 29.1 8.2 27.1 8.0 30.1 7.4 37.3 35.1 37.5

The results in Table 4 show that the easy-to-use SiHy contact lens of this example can release at least 3.1 μg/lens/8 hours of NBD-EO ₄₅ BO ₁₀ , namely 0.00646 μg/lens/minute. With a normal average tear fluid volume of 6.2 ± 2.0 μl (S. Mishima et al., Invest. Ophthalmol. Vis. Sci. 1966, 5: 264-276), the above release rate of the polymeric surfactant will provide a polymeric surfactant concentration of 0.00646 μg·minute ^-1 /6.2 μl=1.04 μg/ml in the lacrimal fluid of the eye.

Example 5

This example illustrates 7 extraction cycles while simulating 1-day wear.

Getting the packaging solution

The packaging solution is prepared by dissolving the purified EO ₄₅ BO ₁₀ that was prepared in Example 3 above and contains the PEO-PBO block copolymer of formula (S2), where R is methyl, m has an average value of 45; and n is characterized by an average value of 10 of copolymer 845 (M _w ~ 700000-1200000 g/mol according to GPC relative to polyethylene oxide standards, M _w /M _n ~ 5.7-8.5) provided by ISP, and other necessary components in water to give the following composition: 150 ppm EO ₄₅ BO ₁₀ , 1 wt % copolymer 845, 0.77 wt % NaCl, 0.076 wt % NaH ₂ PO ₄ ·H ₂ O and 0.47 wt % Na ₂ HPO ₄ •7H ₂ O.

Lens packaging

The SiHy contact lenses prepared in Example 2 were individually packaged and sealed in PP blister packs each containing 0.65 ml of the packaging solution prepared above. Sealed lens packages are autoclaved at approximately 121 ^° C. for approximately 45 minutes.

The amount of EO ₄₅ BO ₁₀ absorbed by an easy-to-use SiHy contact lens is calculated as (C _{before autoclaving} - C _{after autoclaving} )*0.65 ml. C _{before autoclaving} is the concentration of EO ₄₅ BO ₁₀ in the packaging solution before autoclaving and found to be 150 ppm; C _{after autoclaving} is the concentration of EO ₄₅ BO ₁₀ in the packaging solution after autoclaving, and found to be 84-91 ppm; and the calculated amount of EO ₄₅ BO ₁₀ absorbed by the easy-to-use SiHy lens is 38-43 µg/lens.

UPLC method

UPLC analysis is performed on a Waters H-Class system equipped with an ELSD (Evaporative Light Scattering Detector) and PDA (Photo Diode Array Detector) with column heater or equivalent. Column 5 µm C-4 300Å; 50 mm x 4.6 mm (eg Phenomenex Jupiter or equivalent) and Empower 3 software. The ELSD detector is designed to detect EO ₄₅ BO ₁₀ at the following settings: gas (50 psi); atomizer (mode - heating). The PDA detector is designed to detect copolymer 845 at a UV wavelength of 227 nm. The sample volume is 250.0 μl. The temperature in the sample compartment is set at 25°C. The conditions for the column are as follows: column temperature: 60°C; pressure: ~2000 psi inch. Mobile phase A is 0.5M ammonium formate; mobile phase B is 0.04% TFA (trifluoroacetic acid)/methanol. The analysis time is 30 minutes.

The suitability of the system is confirmed by calculating the % RSD (relative standard deviation) of the peak area for the first 5 injections of the target concentration of 1.0% for Co-845 and 150 ppm for EO ₄₅ BO ₁₀ . All %RSD values for each analyte are less than 1.0%, which is below the maximum validation rate of 10%. The position of the peaks is also within the normal range, which corresponds to 1 minute for a change in retention time.

Samples for UPLC analysis are prepared as follows. For analysis of each extraction medium used in each of the 7 cycles, the solvent (water) is evaporated and substances, including polymeric surfactant (EO ₄₅ BO ₁₀ ), are redissolved in 500 μl of UPW for analysis by UPLC.

One skilled in the art will appreciate that by using a smaller volume (eg, 0.25 ml) of UPW when preparing a UPLC sample, the concentration of the polymeric surfactant and thus the accuracy of the assay can be increased.

For the analysis of each extraction medium used in each of the 7 cycles, the solvent (PBS or OFR) is injected directly for analysis using UPLC.

7 cycles of 24-hour water extraction

Conduct seven cycles of 24-hour water extraction of SiHy contact lenses after storing sealed and autoclaved lens packages at room temperature for approximately 12 months, as follows. In the 1st cycle, each of the 10 lenses is removed from the sealed package and blotted; and then 10 soaked lenses are soaked together in 2 ml of fresh PBS (or water only for comparison in this example) in one vial, which is kept with shaking in a water bath at 35ºC for 24 hours. In the 2nd cycle all PBS (or water) used in 1st cycle, pipette from the vial and save for later analysis using UPLC; add 2 ml of fresh PBS (or water) to the vial, which in turn is kept with shaking in a water bath to soak 10 lenses at 35ºC for 24 hours. In cycles from the 3rd on the 7th extraction is carried out similarly to the 2nd cycle. All extract media (PBS or water) after soaking are stored in a freezer until analyzed by UPLC.

Quantity ( ) EO ₄₅ BO ₁₀ released per easy-to-use SiHy lens is calculated according to the following equation,

, in which

is the volume of UPW or PBS (0.5 ml for UPW and 1.0 ml for PBS) used in the preparation of the UPLC sample, and represents the number (10) lenses used in 7 cycles of 24-hour water extraction. The amounts of EO ₄₅ BO ₁₀ and copolymer 845 (Co-845) released per lens for 24 hours are shown in Table 5.

Table 5

Cycle No. Amount released in H ₂ O (µg/lens) Amount released in PBS (µg/lens) EO ₄₅ BO ₁₀ Co-845 EO ₄₅ BO ₁₀ Co-845 1 1.3 0 1.6 0 2 1.0 0 1.1 0 3 0.7 0 1.0 0 4 0.8 0 1.0 0 5 0.6 0 0.8 0 6 0.6 0 0.8 0 7 NM NM 0.8 0 Total amount released 5.0 0 7.2 0

* NM=not measured

In the case of 10 lenses placed in 2 ml PBS, after 7 cycles of 24-hour aqueous extraction, approximately 35.8-38 μg EO ₄₅ BO ₁₀ remained in each lens.

It has been found that no detectable amount of copolymer 845 can be released by easy-to-use SiHy contact lenses, indicating that copolymer 845 cannot penetrate SiHy lenses during autoclaving and probably cannot bind to the surface in an amount sufficient to release into the extractive medium in the 1st cycle.

It has also been found that easy-to-use SiHy contact lenses can release EO ₄₅ BO ₁₀ in PBS to a greater extent than in water at 35 ^° C. (S1DW).

In addition, the amount of EO ₄₅ BO ₁₀ released into the 1st cycle extraction media was found to be significantly higher than in the extraction media of other cycles, indicating the release of polymeric surfactant located on the surface and in the region immediately below the surface. , into the extracting medium of the 1st cycle.

7 extraction cycles while simulating 1-day wear

In this example, seven extraction cycles of S1DW SiHy contact lenses after storage of sealed and autoclaved lens packages at room temperature for approximately 12 months are performed according to the procedures described in Example 1, except that one lens and all PBS are used. as extraction media after each extraction run, store S1DW in a freezer until analysis by UPLC. Hermetic packaging for lenses

Quantity ( ) EO ₄₅ BO ₁₀ released per easy-to-use SiHy lens is calculated according to the following equation,

in which is the volume (1.0 ml) of PBS used in sample preparation for UPLC, and represents the number (1) lenses used in 7 cycles of extraction S1DW in this example. The amounts of EO ₄₅ BO ₁₀ and copolymer 845 (Co-845) released per lens for 24 hours are shown in Table 6.

Table 6

Cycle No. Amount released in PBS (µg/lens/24 hours) EO ₄₅ BO ₁₀ Co-845 1 3.9 0 2 2.4 0 3 2.7 0 4 2.3 0 5 1.4 0 6 1.3 0 7 1.2 0 Total amount released 15.2 0

Table 7 shows that after 7 cycles of S1DW extraction, approximately 27.8 μg of EO ₄₅ BO ₁₀ remained in each lens, that no detectable amount of copolymer 845 could be released by easy-to-use SiHy contact lenses, indicating that the copolymer 845 cannot penetrate SiHy lenses during autoclaving and probably cannot bind on the surface in sufficient quantity to be released into the extraction medium in the 1st cycle, and that the amount of EO ₄₅ BO ₁₀ released into the extraction medium is 1- th cycle, significantly higher than in the extraction media of other cycles, indicating the release of the polymeric surfactant, located on the surface and in the area immediately below the surface, in the extraction medium of the 1st cycle.

Example 6

Receipt of packaging solutions

Five packaging solutions are prepared by dissolving purified EO ₄₅ BO ₁₀ , which is obtained in example 3 above and contains a PEO-PBO block copolymer of formula (S2), while R is methyl, m is characterized by an average value of 45; and n is characterized by an average value of 10 of copolymer 845 (M _w ~ 700000-1200000 g/mol according to GPC relative to polyethylene oxide standards, M _w /M _n ~ 5.7-8.5) provided by ISP, and other necessary components in water to give the following composition: one of five different concentrations (50 ppm, 100 ppm, 150 ppm, 250 ppm and 400 ppm) EO ₄₅ BO ₁₀ , 1 wt% copolymer 845, 0.77 wt% NaCl, 0.076% by weight of NaH ₂ PO ₄ ⋅H ₂ O and 0.47% by weight of Na ₂ HPO ₄ ⋅7H ₂ O.

Lens packaging

Two types of SiHy lenses: SiHy contact lenses prepared in accordance with the procedures described in Example 2, and SiHy plasma treated contact lenses which have an equilibrium moisture content (EWC) of approximately 33% by weight and obtained in accordance with the procedures described in Example 3 in US9829723 are individually packaged and sealed in PP blister packs each containing 0.65 ml of one of the five packaging solutions prepared above. Sealed lens packages are autoclaved at approximately 121 ^° C. for approximately 45 minutes. The resulting lenses, autoclaved in sealed lens packs, are subjected to the testing and characterization described below. Sealed and autoclaved lens packages are stored at room temperature for less than 3 weeks prior to the tests described below.

7 extraction cycles while simulating 1-day wear

Seven S1DW extraction cycles of freshly made SiHy contact lenses (room temperature storage time less than about 3 weeks) were performed according to the procedures described in Example 5. As in Example 5, in this example one lens was used for 7 S1DW extraction cycles.

Changes in lens diameter after 7 extraction cycles S1DW

Lens diameters were determined according to the procedures described in Example 1. Control lenses, which were SiHy contact lenses prepared according to the procedures described in Example 2 and individually sealed and autoclaved in PBS in PP blister packs, were found to each containing 0.65 ml PBS had a mean lens diameter (DIA _control ) of 14.04±0.02 mm. The tested SiHy contact lenses, prepared according to the procedures described in Example 2, and sealed and autoclaved in one of the five packaging solutions obtained above, in lens packages, are characterized by the values (listed in Table 7) of the lens diameter immediately after opening the packages (DIA _OOP ) and lens diameter after 7 S1DW extraction cycles (DIA _{7 S1DW extraction} ).

Table 7

[EO ₄₅ BO ₁₀ ] (ppm) in packaging solution 50 100 150 250 400 DIA _OOP (mm) 14.14±
0.02 14.14±
0.03 14.15±
0.02 14.18±
0.01 14.23±
0.02 ∆DIA _absorption (mm)* 0.10 0.10 0.11 0.14 0.19 DIA _{7 S1DW extraction} (mm) 14.05±
0.01 14.06±
0.01 14.07±
0.01 14.09±
0.02 14.12±
0.01 ∆DIA _release (mm)* 0.09 0.08 0.08 0.09 0.11

* ∆DIA _absorption =DIA _OOP - DIA _control ; ∆DIA _release =DIA _{7 S1DW extraction} - DIA _OOP

The results show that lens diameters for SiHy contact lenses that have an EWC of approximately 54% by weight and do not contain any coating before autoclaving in a packaging solution including EO ₄₅ BO ₁₀ can increase after autoclaving, indicating that EO ₄₅ BO ₁₀ can penetrate SiHy contact lenses and be distributed in their polymer matrix during autoclaving in a packaging solution including EO ₄₅ BO ₁₀ .

The results also show that the lens diameter for the easy-to-use SiHy contact lens of the present invention can decrease after 7 S1DW extraction cycles (i.e. approximately corresponding to 7 days of continuous wear), indicating that EO ₄₅ BO ₁₀ is significantly is absorbed and distributed in the polymer matrix of the easy-to-use SiHy contact lens of the present invention and can be released with tears when the lens is worn on the eye.

Example 7

Preparation of packaging solutions

Copolymer 845 (M _w ~ 700,000-1,200,000 g/mol according to GPC against polyethylene oxide standards, M _w /M _n ~ 5.7-8.5) was obtained from ISP. Polymeric surfactant, EO ₄₅ BO ₁₀ copolymer containing a PEO-PBO block copolymer of formula (S2), wherein R is methyl, m has an average value of 45; and n has an average value of 10, obtained in accordance with the procedures described in US8318144.

Four packaging solutions (packaging solutions I-IV) are prepared by dissolving the various components in water, which are shown in Table 2, according to the procedures described in Example 3.

Lens packaging

The SiHy contact lenses prepared in Example 2 are individually packaged and sealed in PP blister packs each containing 0.65 ml of packaging solution III or IV (prepared above) or in vials each containing approximately 2 ml of packaging solution I or II (obtained above). Sealed lens packages are autoclaved at approximately 121 ^° C. for approximately 45 minutes. Sealed and autoclaved lens packages are stored at room temperature for less than 3 weeks prior to the tests described below.

7 extraction cycles while simulating 1-day wear

Seven S1DW extraction cycles of freshly made SiHy contact lenses (room temperature storage time less than about 3 weeks) were performed according to the procedures described in Example 5. As in Example 5, in this example one lens was used for 7 S1DW extraction cycles.

Wettability of easy-to-use SiHy contact lenses

The static water contact angles (WCA _OOP ) of easy-to-use SiHy contact lenses immediately after opening the packages and the static water contact angles (WCA _{7_S1DW} ) of easy-to-use SiHy contact lenses after 7 S1DW extraction cycles were determined according to the procedures described in Example 1 The results are shown in Table 8.

Table 8

Packing Solution No. I (control) II III IV WCA _OOP (degrees) 82±3 70±2 66±4 51±2 WCA _{7_S1DW extraction} (degrees) 87±1 86±1 81±2 72±1

All publications, patents and publications of patent applications that have been mentioned in this application above, are incorporated by reference in their entirety.

Claims (118)

1. An ophthalmic product containing a sealed and autoclaved package that includes an autoclaved packaging solution and an easy-to-use silicone hydrogel contact lens immersed in it, wherein the autoclaved packaging solution is a buffered saline solution having a pH of 6.0 to 8.0 and includes a polymeric surfactant that contains at least one hydrophilic poly(oxyethylene) segment and at least one hydrophobic a poly(oxybutylene) segment and is characterized by an HLB value of 11 to 16 and a number average molecular weight of 800 to 20,000 daltons, wherein the easy-to-use silicone hydrogel contact lens is obtained by packaging, sealing and autoclaving a preformed silicone hydrogel contact lens in a packaging solution prior to autoclaving containing a polymeric surfactant, where the preformed silicone hydrogel contact lens does not contain any coating on it and does not contain a polymeric surfactant, while the preformed silicone hydrogel contact lens is characterized by an equilibrium moisture content of 38 to 80% by weight, an elastic modulus of 0, 2 to 1.5 MPa and oxygen permeability of at least 50 barrer, while the easy-to-use silicone hydrogel contact lens has the ability to release a polymeric surfactant in an amount of at least 0.2 µg/lens/24 hours as measured in a water extraction process consisting of 7 extraction cycles at simulated 1 - daily wear where 7 extraction cycles in simulated 1-day wear is an aqueous extraction process consisting of: (a) 1 extraction cycle in simulated 1-day wear, which includes (i) extracting and blotting with one to three easy-to-use silicone - hydrogel contact lenses from sealed packages, (ii) soaking soaked lungs in use of silicone hydrogel contact lenses together in 1.0 ml of fresh phosphate-buffered saline (PBS), which is characterized by a pH of 7.2 ± 0.2 at 25 ° C and contains approximately 0.076 wt.% NaH ₂ PO ₄ ⋅H ₂ O, approximately 0.31 wt.% Na ₂ HPO ₄ ⋅2H ₂ O and approximately 0.77 wt.% NaCl, as extraction medium in one bottle in for 24 hours at 35°C with agitation, (iii) pipetting all of the PBS used in the 1st extraction cycle in simulated 1-day wear from the vial and (iv) analysis of the pipetting PBS used in the 1st cycle extractions while simulating 1-day wear; and (b) 2nd to 7th extraction cycles in simulated 1-day wear, each of which includes (i) adding 1.0 ml of fresh PBS as extraction medium to a vial containing easy-to-use silicone hydrogel contacts lenses that were subjected to a previous extraction cycle in simulated 1-day wear, (ii) soaking easy-to-use silicone hydrogel contact lenses in added 1 ml fresh PBS as extraction medium for 24 hours at 35°C with agitation, (iii ) pipetting all of the PBS used in the current extraction cycle in simulated 1-day wear from the vial and (iv) analysis of the pipetted PBS used in the current extraction cycle in simulated 1-day wear, where the polymeric surfactant releasing capacity is the amount of polymeric surfactant released per lens over 24 hours into the extraction medium that was used in the last cycle of 7 extraction cycles while simulating 1-day wear, wherein the easy-to-use silicone hydrogel contact lens is further characterized by a first static water contact angle, WCA _OOP , of 75° or less, as measured directly after opening the sealed package by the sessile drop method, a second static water contact angle, WCA _{7_S1DW} , of 85° or less as measured by sessile drop method immediately after 7 extraction cycles under simulated 1-day wear, oxygen permeability of at least 50 barrer, elastic modulus of 0.2 to 1.5 MPa, and equilibrium moisture content of 38 to 80% by weight wherein the polymeric surfactant is present in the packaging solution prior to autoclaving in an amount to provide a difference in lens diameter between an easy-to-use silicone hydrogel contact lens and a control lens that is pre-autoclaved in phosphate buffered saline, not containing a polymeric surfactant, less than 0.20 mm. 2. The ophthalmic product of claim 1, wherein the easy-to-use silicone hydrogel contact lens is characterized by the ability to release a polymeric surfactant in an amount of at least 0.4 µg/lens/24 hours as measured by an aqueous extraction process, consisting of 7 extraction cycles while simulating 1-day wear. 3. An ophthalmic product according to claim 1 or 2, wherein the polymeric surfactant is a diblock copolymer designated as PEO-PBO or a triblock copolymer designated as PEO-PBO-PEO or PBO-PEO-PBO, wherein PEO is a poly(oxyethylene) segment and PBO is a poly(oxybutylene) segment. 4. Ophthalmic product according to any one of paragraphs. 1-3, where the polymeric surfactant is a diblock copolymer of formula (S1) RO - (EO) _m (BO) _n - H (S1), where R is selected from the group consisting of hydrogen, methyl, ethyl, propyl and butyl; EO is ethylene oxide -C ₂ H ₄ O-; BO is butylene oxide -C ₄ H ₈ O-; m is an integer having an average value of 10 to 250; and n is an integer having an average value of from 5 to 125, provided that the value of m/n is from about 2:1 to about 10:1. 5. Ophthalmic product according to any one of paragraphs. 1-4, where the polymeric surfactant is a diblock copolymer of formula (S2) (S2) where R is selected from the group consisting of hydrogen, methyl, ethyl, propyl and butyl; m is an integer having an average value of 10 to 250; and n is an integer having an average value of from 5 to 125, provided that the value of m/n is from about 2:1 to about 10:1. 6. Ophthalmic product according to any one of paragraphs. 1-5, wherein the easy-to-use silicone hydrogel contact lens contains at least about 40 µg/lens of polymeric surfactant. 7. Ophthalmic product according to any one of paragraphs. 1-6, wherein the packaging solution prior to autoclaving further comprises from about 0.1% to about 2% by weight of a hydrophilic polymer having a number average molecular weight of at least 100,000 daltons. 8. An ophthalmic product according to claim 7, wherein the hydrophilic polymer is polyvinylpyrrolidone or a copolymer of N-vinylpyrrolidone and at least one amine-containing vinyl monomer, wherein the amine-containing vinyl monomer is selected from the group consisting of an alkylaminoalkyl methacrylate containing 8-15 carbon atoms, an alkylaminoalkyl acrylate containing 7-15 carbon atoms, dialkylaminoalkylmethacrylate containing 8-20 carbon atoms, dialkylaminoalkylacrylate containing 7-20 carbon atoms, and N-vinylalkylamide containing 3-10 carbon atoms. 9. Ophthalmic product according to any one of paragraphs. 1-8, wherein the preformed silicone hydrogel contact lens is a naturally wetted silicone hydrogel contact lens. 10. Ophthalmic product according to any one of paragraphs. 1-9, wherein the preformed silicone hydrogel contact lens is comprised of a silicone hydrogel material comprising (1) repeat units of at least one silicone-containing vinyl monomer and/or repeat units of at least one polysiloxane-vinyl crosslinker, and (2) repeating units of at least one hydrophilic vinyl monomer, where said at least one silicone-containing vinyl monomer is selected from the group consisting of a vinyl monomer containing a bis(trialkylsilyloxy)alkylsilyl group, a vinyl monomer containing a tris(trialkylsilyloxy)silyl group, a polysiloxane-vinyl monomer, 3-methacryloxypropylpentamethyldisiloxane, t-butyldimethylsiloxyethylvinylcarbonate, trimethylsilylethylvinylcarbonate and trimethylsilylmethylvinylcarbonate; and combinations thereof. 11. The ophthalmic product of claim 10, wherein the silicone hydrogel material contains repeating units of at least one polysiloxane-vinyl crosslinker, wherein said at least one polysiloxane-vinyl crosslinker comprises a vinyl crosslinker of formula (I) wherein υ1 is an integer from 30 to 500; and ω1 is an integer from 1 to 75, provided that ω1/υ1 is from about 0.035 to about 0.15; X ₀₁ represents O or NR _N in which _RN represents hydrogen or C ₁ -C ₁₀ alkyl; R _o is hydrogen or methyl; R _I1 and R _I2 independently of each other represent a substituted or unsubstituted C ₁ -C ₁₀ alkylene divalent radical or a divalent radical -R _I4 -OR _I5 -, in which R _I4 and R _I5 independently of each other represent a substituted or unsubstituted C ₁ -C ₁₀ alkylene divalent radical; R _I3 is a monovalent radical of any of the formulas (Ia)-(Ie): p1 is zero or 1; m1 is an integer from 2 to 4; m2 is an integer from 1 to 5; m3 is an integer from 3 to 6; m4 is an integer from 2 to 5; R _I6 is hydrogen or methyl; R _I7 is a C ₂ -C ₆ hydrocarbon radical having a valency (m2+1); R _I8 is a C ₂ -C ₆ hydrocarbon radical having a valency (m4+1); R _I9 is ethyl or hydroxymethyl; R _I10 is methyl or hydroxymethyl; R _I11 is hydroxyl or methoxy; X _I1 is a sulfur bridge -S- or a bridge based on a tertiary amine -NR _I12 -, in which R _I12 is C ₁ -C ₁ alkyl, hydroxyethyl, hydroxypropyl or 2,3-dihydroxypropyl; And X _I2 is an amide bridge or , in which R _I13 represents hydrogen or C ₁ -C ₁₀ alkyl. 12. The ophthalmic product of claim 10, wherein the silicone hydrogel material contains repeating units of at least one polysiloxane-vinyl crosslinker, wherein said at least one polysiloxane-vinyl crosslinker comprises a vinyl crosslinker of any of formulas (1)-( 7): in which υ1 is an integer from 30 to 500; υ2 is an integer from 5 to 50; υ3 is an integer from 5 to 100; ω2 and ω3 are independently an integer from 1 to 15; a1 and g1 are independently equal to zero or 1; h1 is an integer from 1 to 20; and h2 is an integer from 0 to 20; m1 and m3 are independently 0 or 1, m2 is an integer from 1 to 6, m4 is an integer from 1 to 5, m5 is 2 or 3; q1 is an integer from 1 to 20, q2 is an integer from 0 to 20, q3 is an integer from 0 to 2, q4 is an integer from 2 to 50, q5 and q6 independently of each other are a number from 0 to 35, provided that (q4+q5+q6) is an integer from 2 to 50; x+y is an integer from 10 to 30; e1 is an integer from 5 to 100, p1 and b1 independently of each other are an integer from 0 to 50, provided that (e1+p1+b1)≥10 and ≥2 if (p1+b1)≥1; R _o is H or methyl; R ₁ , R _1n , R _2n , R _3n and R _4n independently of each other represent H or C ₁ -C ₄ alkyl containing from 0 to 2 hydroxyl groups; R _n5 is H or C ₁ -C ₁₀ alkyl; R ₂ is a C ₄ -C ₁₄ hydrocarbon divalent radical; R ₃ is a C ₂ -C ₆ alkylene divalent radical; R ₄ and R ₅ independently of each other represent a C ₁ -C ₆ alkylene divalent radical or a C ₁ -C ₆ alkyleneoxy-C ₁ -C ₆ alkylene divalent radical; R ₆ and R ₇ independently of each other represent a C ₁ -C ₆ alkylene divalent radical or a C ₁ -C ₆ alkoxy-C ₁ -C ₆ alkylene divalent radical; R ₈ and R ₉ independently of each other represent a substituted or unsubstituted C ₁ -C ₁₂ alkylene divalent radical; X _o , X ₁ ', X _o1 , X ₀₂ and X ₀₃ are independently O or NR ₁ ; X ₁ is O, NR ₁ , NHCOO, OCONH, CONR ₁ or NR ₁ CO; X _o4 is -COO- or -CONR _n5 -; X _o5 and X _o7 independently represent a direct link, -COO- or -CONR _n5 -; X _o6 is a direct bond, C ₁ -C ₆ alkylene divalent radical, C ₁ -C ₆ alkyleneoxy divalent, -COO- or -CONR _n5 -; X _o8 is a direct link or -COO-; X _o9 is O or NR _n5 ; X ₁₀ is a direct bond, C ₁ -C ₆ alkylene divalent radical, -COO- or -CONR _n5 -; E ₁ ' is a monovalent radical ; E ₂ is a monovalent radical ; E ₃ is a monovalent radical ; E ₄ is a monovalent radical or ; L ₁ is a C ₂ -C ₈ alkylene divalent radical or divalent radical L ₁ ' is a C ₂ -C ₈ alkylene divalent radical which contains or does not contain one hydroxyl group; L ₁ "is a C ₃ -C ₈ alkylene divalent radical, which contains one hydroxyl group or does not contain it; L ₃ is a divalent radical , while PE is a divalent radical or ; L ₃ ' is a C ₃ -C ₈ alkylene divalent radical; L ₄ is a divalent radical hp L ₁ is a divalent radical ; hp L ₂ is a divalent radical ; hp L ₃ is a divalent radical ; hp L ₄ is a divalent radical or ; pOAlk is a divalent radical , while EO is an oxyethylene unit (-CH ₂ CH ₂ O-), PO is an oxypropylene unit ( ) and BO is an oxybutylene unit ( ); M ₀ is a C ₃ -C ₈ alkylene divalent radical; M ₁ is a C ₄ -C ₁₄ hydrocarbon divalent radical; M ₂ and M ₃ independently of each other represent a C ₁ -C ₆ alkylene divalent radical; J ₀ is a C ₁ -C ₁₂ hydrocarbon radical containing from 0 to 2 hydroxyl or carboxyl groups; G1 is a direct bond, C ₁ -C ₄ alkylene divalent radical or divalent radical , , , , in which M _o is associated with the Si atom, while X ₀₄ -X ₁₀ are associated with the -CH ₂ - group in formula (7), and at least one of J ₀ and G1 in formula (7) contains at least one a moiety selected from the group consisting of hydroxyl groups, urethane bridge -OCONH-, amino groups -NHR ₀ , amine bridges -NH-, amide bridges -CONH-, carboxyl groups and combinations thereof; G ₂ is a C ₁ -C ₄ alkylene divalent radical or divalent radical G ₃ is a divalent radical , where h3 and h4 are independently 1 or 0; G4 is a divalent radical representing any of (a) -NR ₃ '-, in which R ₃ ' represents hydrogen or C ₁ -C ₃ alkyl, (b) , (c) -NR ₀ -G ₅ -NR ₀ -, in which G ₅ represents a C ₁ -C ₆ alkylene divalent radical, 2-hydroxylpropylene divalent radical, 2-(phosphonyloxy)propylene divalent radical, 1,2-dihydroxyethylene divalent radical, 2,3-dihydroxybutylene divalent radical, and (d) -OG ₆ -O-, in which G ₆ represents C ₁ -C ₆ alkylene divalent radical, divalent radical , in which h4' equals 1 or 2, divalent radical , divalent radical , where h5 is an integer from 1 to 5, a divalent radical in which h6 is 2 or 3, or a substituted C ₃ -C ₈ alkylene divalent radical containing a hydroxyl group or a phosphonyloxy group; Y ₁ is a C ₁ -C ₆ alkylene divalent radical, 2-hydroxylpropylene divalent radical, 2-(phosphonyloxy)propylene divalent radical, 1,2-dihydroxyethylene divalent radical, divalent radical or divalent radical ; Y ₂ is a divalent radical ; Y ₃ is a divalent radical or ; Z ₀ is a direct bond or a C ₁ -C ₁₂ alkylene divalent radical; Z ₁ is a C ₁ -C ₆ alkylene divalent radical, a hydroxyl or methoxy substituted C ₁ -C ₆ alkylene divalent radical, or a substituted or unsubstituted phenylene divalent radical, Z ₂ is a C ₁ -C ₆ alkylene divalent radical, hydroxyl or methoxy substituted C ₁ -C ₆ alkylene divalent radical, dihydroxyl or dimethoxy substituted C ₂ -C ₆ alkylene divalent radical, divalent radical -C ₂ H ₄ -(OC ₂ H ₄ ) _m2 -, divalent radical -Z ₄ -SSZ ₄ -, hydroxyl- or methoxy-substituted C ₁ -C ₆ alkylene divalent radical or substituted or unsubstituted phenylene divalent radical, Z ₃ is a divalent radical representing any of (a) -NR _n3 -, (b) , (c) -NR ₀ -Z ₅ -NR ₀ - and (d) -OZ ₆ -O-, Z ₄ is a C ₁ -C ₆ alkylene divalent radical, Z ₅ is a C ₁ -C ₆ alkylene divalent radical, 2-hydroxylpropylene divalent radical, 2-(phosphonyloxy)propylene divalent radical, 1,2-dihydroxyethylene divalent radical, 2,3-dihydroxybutylene divalent radical, Z ₆ is (a) a C ₁ -C ₆ alkylene divalent radical, (b) a divalent radical , , , or (c) a substituted C ₃ -C ₈ alkylene divalent radical containing a hydroxyl group or a phosphonyloxy group, Z ₇ is a divalent radical . 13. The ophthalmic product of claim 10, wherein the silicone hydrogel material contains repeating units of at least one polysiloxane-vinyl crosslinker, wherein said at least one polysiloxane-vinyl crosslinker is an α,ω-bis[3] terminated polydimethylsiloxane -(meth)acrylamidopropyl] groups, polydimethylsiloxane with terminal α,ω-bis[3-(meth)acryloxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[3-(meth)acryloxy-2-hydroxypropyloxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[3-(meth)acryloxyethoxy-2-hydroxypropyloxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[3-(meth)acryloxypropyloxy-2-hydroxypropyloxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis [3-(meth)acryloxyisopropyloxy-2-hydroxypropyloxypropyl] groups, α,ω-bis[3-(meth)acryloxybutyloxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)terminal polydimethylsiloxane acrylamideethoxy-2-hydroxypropyloxypropyl] groups, α,ω-bis[3-(meth)acrylamidopropyloxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidoisopropyloxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane groups, α,ω-bis[3-(meth)acrylamidobutyloxy-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acryloxyethylamino-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α-terminated polydimethylsiloxane ,ω-bis[3-(meth)acryloxypropylamino-2-hydroxypropyloxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[3-(meth)acryloxybutylamino-2-hydroxypropyloxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[( meth)acrylamidoethylamino-2-hydroxypropyloxypropyl] groups, α,ω-bis[3-(meth)acrylamidopropylamino-2-hydroxypropyloxypropyl]-terminated polydimethylsiloxane, α,ω-bis[3-(meth)acrylamidobutylamino-2- hydroxypropyloxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[(meth)acryloxy-2-hydroxypropyloxyethoxypropyl] groups, polydimethylsiloxane with terminal α,ω-bis[(meth)acryloxy-2-hydroxypropyl-N-ethylaminopropyl] groups, α, ω-bis[(meth)acryloxy-2-hydroxypropylaminopropyl]polydimethylsiloxane, polydimethylsiloxane with terminal α,ω-bis[(meth)acryloxy-2-hydroxypropyloxy(polyethyleneoxy)propyl] groups, polydimethylsiloxane with terminal α,ω-bis[(meth )acryloxyethylaminocarbonyloxyethoxypropyl] groups, α,ω-bis[(meth)acryloxyethylaminocarbonyloxy(polyethyleneoxy)propyl]-terminated polydimethylsiloxane, or combinations thereof. 14. Ophthalmic product according to any one of paragraphs. 10-13, wherein said at least one hydrophilic vinyl monomer comprises: (1) an alkyl(meth)acrylamide selected from the group consisting of (meth)acrylamide, N,N-dimethyl(meth)acrylamide, N-ethyl(meth )acrylamide, N,N-diethyl(meth)acrylamide, N-propyl(meth)acrylamide, N-isopropyl(meth)acrylamide, N-3-methoxypropyl(meth)acrylamide and combinations thereof; (2) a hydroxyl-containing acrylic monomer selected from the group consisting of N-2-hydroxyethyl(meth)acrylamide, N,N-bis(hydroxyethyl)(meth)acrylamide, N-3-hydroxypropyl(meth)acrylamide, N-2- hydroxypropyl(meth)acrylamide, N-2,3-dihydroxypropyl(meth)acrylamide, N-tris(hydroxymethyl)methyl(meth)acrylamide, 2-hydroxyethyl(meth)acrylate, 3-hydroxypropyl(meth)acrylate, 2-hydroxypropyl( meth)acrylate, glycerol methacrylate (GMA), di(ethylene glycol)(meth)acrylate, tri(ethylene glycol)(meth)acrylate, tetra(ethylene glycol)(meth)acrylate, poly(ethylene glycol)(meth)acrylate having a number average molecular weight not more than 1500, poly(ethylene glycol)ethyl(meth)acrylamide having a number average molecular weight of not more than 1500, and combinations thereof; (3) a carboxyl-containing acrylic monomer selected from the group consisting of 2-(meth)acrylamidoglycolic acid, (meth)acrylic acid, ethylacrylic acid, 3-(meth)acrylamidopropionic acid, 5-(meth)acrylamidopentanoic acid, 4-(meth )acrylamidobutanoic acid, 3-(meth)acrylamido-2-methylbutanoic acid, 3-(meth)acrylamido-3-methylbutanoic acid, 2-(meth)acrylamido-2-methyl-3,3-dimethylbutanoic acid, 3-(meth )acrylamidohexanoic acid, 4-(meth)acrylamido-3,3-dimethylhexanoic acid and combinations thereof; (4) an amine-containing acrylic monomer selected from the group consisting of N-2-aminoethyl(meth)acrylamide, N-2-methylaminoethyl(meth)acrylamide, N-2-ethylaminoethyl(meth)acrylamide, N-2-dimethylaminoethyl(meth )acrylamide, N-3-aminopropyl(meth)acrylamide, N-3-methylaminopropyl(meth)acrylamide, N-3-dimethylaminopropyl(meth)acrylamide, 2-aminoethyl(meth)acrylate, 2-methylaminoethyl(meth)acrylate, 2 -ethylaminoethyl(meth)acrylate, 3-aminopropyl(meth)acrylate, 3-methylaminopropyl(meth)acrylate, 3-ethylaminopropyl(meth)acrylate, 3-amino-2-hydroxypropyl(meth)acrylate, trimethylammonium-2-hydroxypropyl( meth)acrylate, dimethylaminoethyl(meth)acrylate, and combinations thereof; (5) N-vinylamide monomer selected from the group consisting of N-vinylpyrrolidone (also known as N-vinyl-2 - pyrrolidone), N-vinyl-3-methyl-2-pyrrolidone, N-vinyl-4-methyl- 2-pyrrolidone, N-vinyl-5-methyl-2-pyrrolidone, N-vinyl-6-methyl-2-pyrrolidone, N-vinyl-3-ethyl-2-pyrrolidone, N-vinyl-4,5-dimethyl- 2-pyrrolidone, N-vinyl-5,5-dimethyl-2-pyrrolidone, N-vinyl-3,3,5-trimethyl-2-pyrrolidone, N-vinylpiperidone (also known as N-vinyl-2-piperidone), N-vinyl-3-methyl-2-piperidone, N-vinyl-4-methyl-2-piperidone, N-vinyl-5-methyl-2-piperidone, N-vinyl-6-methyl-2-piperidone, N- vinyl-6-ethyl-2-piperidone, N-vinyl-3,5-dimethyl-2-piperidone, N-vinyl-4,4-dimethyl-2-piperidone, N-vinyl caprolactam (also known as N-vinyl-2 -caprolactam), N-vinyl-3-methyl-2-caprolactam, N-vinyl-4-methyl-2-caprolactam, N-vinyl-7-methyl-2-caprolactam, N-vinyl-7-ethyl-2- caprolactam, N-vinyl-3,5-dimethyl-2-caprolactam, N-vinyl-4,6-dimethyl-2-caprolactam, N-vinyl-3,5,7-trimethyl-2-caprolactam, N-vinyl- N-methylacetamide, N-vinylformamide, N-vinylacetamide, N-vinylisopropylamide, N-vinyl-N-ethylacetamide, N-vinyl-N-ethylformamide and mixtures thereof; (6) a methylene-containing pyrrolidone monomer selected from the group consisting of 1-methyl-3-methylene-2-pyrrolidone, 1-ethyl-3-methylene-2-pyrrolidone, 1-methyl-5-methylene-2-pyrrolidone, 1 -ethyl-5-methylene-2-pyrrolidone, 5-methyl-3-methylene-2-pyrrolidone, 5-ethyl-3-methylene-2-pyrrolidone, 1-n-propyl-3-methylene-2-pyrrolidone, 1 -n-propyl-5-methylene-2-pyrrolidone, 1-isopropyl-3-methylene-2-pyrrolidone, 1-isopropyl-5-methylene-2-pyrrolidone, 1-n-butyl-3-methylene-2-pyrrolidone , 1-tert-butyl-3-methylene-2-pyrrolidone and combinations thereof; (7) an acrylic monomer containing a C ₁ -C ₄ alkoxyethoxy group and selected from the group consisting of ethylene glycol methyl ester (meth)acrylate, di(ethylene glycol methyl ester) (meth)acrylate, tri(ethylene glycol) methyl ester (meth)acrylate, (meth)acrylate of tetra(ethylene glycol) methyl ether, C ₁ -C ₄ alkoxypoly(ethylene glycol)(meth)acrylate, characterized by a number average molecular weight of not more than 1500, methoxypoly(ethylene glycol)ethyl(meth)acrylamide, characterized by a number average molecular weight of not more than 1500 , and their combinations; (8) a vinyl ether monomer selected from the group consisting of ethylene glycol monovinyl ether, di(ethylene glycol) monovinyl ether, tri(ethylene glycol) monovinyl ether, tetra(ethylene glycol) monovinyl ether, poly(ethylene glycol) monovinyl ether, ethylene glycol methyl vinyl ether, methyl vinyl ether di(ethylene glycol) ether, tri(ethylene glycol) methyl vinyl ether, tetra(ethylene glycol) methyl vinyl ether, poly(ethylene glycol) methyl vinyl ether, and combinations thereof; (9) an allyl ether monomer selected from the group consisting of ethylene glycol monoallyl ether, di(ethylene glycol) monoallyl ether, tri(ethylene glycol) monoallyl ether, tetra(ethylene glycol) monoallyl ether, poly(ethylene glycol) monoallyl ether, ethylene glycol methylallyl ether, methylallyl di(ethylene glycol) ether, tri(ethylene glycol) methyl allyl ether, tetra(ethylene glycol) methyl allyl ether, poly(ethylene glycol) methyl allyl ether, and combinations thereof; (10) a phosphorylcholine-containing vinyl monomer selected from the group consisting of (meth)acryloyloxyethylphosphorylcholine, (meth)acryloyloxypropylphosphorylcholine, 4-((meth)acryloyloxy)butyl-2'-(trimethylammonio)ethyl phosphate, 2-[(meth)acryloylamino]ethyl -2'-(trimethylammonio)ethyl phosphate, 3-[(meth)acryloylamino]propyl-2'-(trimethylammonio)ethylphosphate, 4-[(meth)acryloylamino]butyl-2'-(trimethylammonio)ethylphosphate, 5-((meth )acryloyloxy)pentyl-2'-(trimethylammonio)ethyl phosphate, 6-((meth)acryloyloxy)hexyl-2'-(trimethylammonio)ethylphosphate, 2-((meth)acryloyloxy)ethyl-2'-(triethylammonio)ethylphosphate, 2 -((meth)acryloyloxy)ethyl-2'-(tripropylammonio)ethyl phosphate, 2-((meth)acryloyloxy)ethyl-2'-(tributylammonio)ethylphosphate, 2-((meth)acryloyloxy)propyl-2'-(trimethylammonio )ethyl phosphate, 2-((meth)acryloyloxy)butyl-2'-(trimethylammonio)ethylphosphate, 2-((meth)acryloyloxy)pentyl-2'-(trimethylammonio)ethylphosphate, 2-((meth)acryloyloxy)hexyl-2 '-(trimethylammonio)ethyl phosphate, 2-(vinyloxy)ethyl-2'-(trimethylammonio)ethylphosphate, 2-(allyloxy)ethyl-2'-(trimethylammonio)ethylphosphate, 2-(vinyloxycarbonyl)ethyl-2'-(trimethylammonio) ethyl phosphate, 2-(allyloxycarbonyl)ethyl-2'-(trimethylammonio)ethylphosphate, 2-(vinylcarbonylamino)ethyl-2'-(trimethylammonio)ethylphosphate, 2-(allyloxycarbonylamino)ethyl-2'-(trimethylammonio)ethylphosphate, 2-( butenoyloxy)ethyl-2'-(trimethylammonio)ethyl phosphate and combinations thereof; (11) allyl alcohol; (12) N-2-hydroxyethyl vinyl carbamate; (13) N-carboxyvinyl-β-alanine (VINAL); (14) N-carboxyvinyl-α-alanine; (15) or combinations thereof. 15. Ophthalmic product according to any one of paragraphs. 11-14, wherein the silicone hydrogel material comprises (a) repeat units of at least one crosslinker other than siloxane-vinyl, (b) repeat units of at least one miscible vinyl monomer, and/or (c) repeat units of at least at least one UV absorbing vinyl monomer and/or at least one UV/HEVL absorbing vinyl monomer. 16. Ophthalmic product according to any one of paragraphs. 1-15, wherein the static water contact angle of the easy-to-use silicone hydrogel contact lens immediately after opening the sealed and autoclaved package is at least 10 degrees lower than the static water contact angle of the preformed silicone hydrogel contact lens. 17. Ophthalmic product according to any one of paragraphs. 1-16, wherein the polymeric surfactant is present in the packaging solution prior to autoclaving in an amount selected to provide a difference in lens diameter between an easy-to-use SiHy contact lens and a control lens, which is a preformed SiHy contact lens treated with autoclave in a phosphate-buffered saline solution containing no polymeric surfactant, less than 0.20 mm.