MXPA00005106A - Multi-purpose contact lens care compositions - Google Patents

Abstract

Multi-purpose solutions for contact lens care provide substantial lens wearer/user comfort and/or acceptability. Such solutions include an aqueous liquid medium;an antimicrobial component, preferably a biguanide polymer present in an amount of less than about 5 ppm;a surfactant component, preferably a poly(oxyethylene)-poly(oxypropylene) block copolymer surfactant, in an effective amount;a phosphate buffer component in an effective amount;a viscosity inducing component, preferably selected from cellulosic derivatives, in an effective amount;and a tonicity component in an effective amount. Such solutions have substantial performance, comfort and acceptability benefits, which, ultimately, lead to ocular health advantages and avoidance of problems caused by contact lens wear.

Description

COMPOSITIONS OF MULTIPLE PURPOSES FOR THE CARE OF CONTACT LENSES BACKGROUND OF THE INVENTION The present invention relates to compositions for treating, for example, disinfecting, cleaning, soaking or conditioning and wetting contact lenses. More particularly, the invention relates to multi-purpose solutions useful for treating contact lenses, for example, for disinfecting contact lenses, for removing contact lens reservoir material, for rinsing, conditioning and / or wetting contact lenses and similar, which provides comfort and benefit of substantial acceptability to the users of such solutions. Contact lenses need to be treated periodically, eg disinfected, cleaned, soaked and the like, on a regular basis due to the tendency of a variety of ocular and environmental contaminants, microbes and other materials that accumulate in the lenses and / or that They need to provide the lenses with adequate conditioning for safe and comfortable use. It is important a user compliance, that is, that users treat contact lenses on a regular and consistent basis, in order to promote eye health and avoid associated problems. REF .: 119957 with the use of contact lenses. User compliance is improved when the treatment solution that is used provides high degrees of lens usage capacity / user comfort and acceptability. Therefore, it would be advantageous to provide compositions for treating contact lenses which provide such comfort and / or which are accepted by contact lens wearers / users of such compositions. Fu patent U.S. 4,323,467 discloses an aqueous composition combining a substituted ethylenediamine surfactant with poly (oxyethylene) -poly (oxypropylene), a germicidal agent, a viscosity accumulator, a tonicity agent, a sequestering agent, and water to treat rigid contact lenses. This patent describes a germicide such as thimerosal and / or benzalkonium chloride, in a concentration of 0.0005% -0.05%. Fu's patent does not describe the use of any specific shock absorber. Although the Fu patent compositions have multiple utilities, there is potential for discomfort and / or eye irritation, for example, due to relatively high concentrations of germicide and the apparent lack of pH control. British Patent 1,432,345 discloses a contact lens disinfecting composition that includes an ophthalmically acceptable biguanide in a total amount of 0.0005% to 0.05% by weight. The British patent discloses that the solution preferably has a pH of 5 to 8 and uses a phosphate buffer, but also describes the use of additional bactericides, thickeners and nonionic surfactants as well as disodium EDTA in concentrations of at least 0.1. %. Although these compositions are effective as disinfectants for contact lenses, they have the risk of discomfort and / or irritation to the eyes, for example, due to the relatively high concentrations of biguanide and EDTA used. Ogunbiyi et al, U.S. Patent No. 4,758,595 discloses an aqueous solution of a biguanide in an amount of 0.000001 to 0.0003% by weight, in combination with a buffer system of borate, EDTA and one or more surfactants. This U.S. patent additionally states that conventional dampers can be used in addition to the borate buffer but only together with increased amounts of biguanide. Therefore, the general conclusion of this U.S. is that if you are going to use reduced amounts of biguanide, a borate buffer is essential. Although such compositions are useful, the potential for ocular discomfort and irritation still exists in a relatively large percentage of the total population, for example due to the requirement that borate cushion be used. There continues to be a need to improve contact lens treatment systems, for example, multi-purpose solutions, which carry out the desired treatment or treatments of the lenses and, at the same time, provide comfort and acceptability of the wearers. of lenses / substantial user, preferably increased.

BRIEF DESCRIPTION OF THE INVENTION New compositions have been discovered for treating contact lenses. The present compositions, which are multi-purpose aqueous solutions, include antimicrobial components, preferably reduced concentrations of antimicrobial components, in combination with phosphate buffers and viscosity inducing components to provide the desired antimicrobial activity and performance effectiveness and, importantly, , substantial and preferably increased benefits in the comfort and acceptable capacity of lens wearers / users. These compositions are surprising and unexpected in view of the prior art indicated above which uses relatively large concentrations of antimicrobial components and / or buffer systems in addition to the phosphate buffer systems and / or does not use viscosity-inducing components. In addition, the inclusion of one or more additional components in the present compositions is effective to provide additional beneficial properties to the compositions and preferably provides additional benefits of comfort and acceptability to lens wearers / users. The present compositions have many applications for example, as disinfectant, cleansing, soaking, wetting and conditioning compositions for the care of contact lenses, while providing comfort and substantial acceptance capacity for the lens wearer / user. The present compositions preferably increase user compliance, that is, promote regular and consistent care of contact lenses and, ultimately, carry or facilitate better eye health. In one embodiment of the present invention, multi-purpose solutions are provided for the care of contact lenses. Such solutions comprise an aqueous liquid medium; an antimicrobial component in an amount effective to disinfect a contact lens contacting the solution, a surfactant in an amount effective to clean a contact lens that was brought into contact with the solution, a shock absorber component phosphate in an amount "effective to maintain the pH of the solution within a physiologically acceptable range, a viscosity-inducing component present in an effective amount, and a tonicity component in an amount effective to provide the desired tonicity to the solution. The antimicrobial component can be any suitable material, preferably ophthalmically acceptable, effective to disinfect a contact lens that is contacted with the present solutions Preferably, the antimicrobial component is selected from biguanides, biguanide polymers, salts thereof and mixtures of them, and is present in a quantity in the interval or from about 0. 1 ppm to about 3 ppm or less than 5 ppm (w / v). The relatively low preferred concentration of the antimicrobial component has been found to be very effective, in the present compositions, in disinfecting contact lenses that come into contact with the compositions, while at the same time promoting the comfort and acceptability of the carrier. lenses / user. Any suitable surfactant component, preferably ophthalmically acceptable which is effective for cleaning contact lenses can be used. The surfactant component is preferably nonionic and, more preferably, is selected from poly (oxyethylene) -poly (oxypropylene) block copolymers and mixtures thereof. Any suitable viscosity inducing agent or thickener may be included in the present compositions, preferably ophthalmf acceptable. The viscosity-inducing component is preferably selected from derivatives and is present in an amount in the range of about 0.05% to about 0.5% (w / v). Without wishing to limit the invention to any particular theory of operation, it is considered that the presence of a viscosity-inducing component of the present invention at least helps in providing benefits of comfort and acceptability to the carrier. lens / user, which promotes a regular and consistent care of contact lenses and finally leads or facilitates better eye health. The present combinations of components, for example, include such components that induce viscosity, and are effective in providing the grade of comfort benefits and acceptance capacity of the lens wearer / user described herein. Although any suitable tonicity component, preferably ophthalmically acceptable, can be used, a very useful tonicity component is a combination of sodium chloride and potassium chloride. Preferably, the present compositions include an effective amount of a chelating component. Any suitable chelating component, preferably ophthalmically acceptable, can be included in the present compositions, although acid is particularly effective If ethylenediaminetetraacetic (EDTA), salts thereof and mixtures thereof. More preferably, the present compositions include chelating components in effective amounts less than about 0.05% (w / v) and most preferably 0.02% (w / v) or less. Such reduced amounts of chelating component in the present compositions remain effective in providing the desired chelating and / or sequestering functions while at the same time being better tolerated by the eye, whereby the risk of discomfort and / or eye irritation for the eye is reduced. user. Various combinations of two or more of the components indicated above may be used to provide at least one of the benefits described herein. Therefore, all such combinations are included within the scope of the present invention. These and other aspects of the present invention are apparent in the following detailed description, examples and claims.

DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to multi-purpose solutions useful for treating, for example, disinfecting, cleaning, soaking, rinsing, moistening, conditioning and the like, contact lenses. Any contact lens, for example, conventional hard contact lenses, rigid gas permeable contact lenses and soft, hydrophilic or hydrogel contact lenses can be treated in accordance with the present invention. In one embodiment, the present compositions comprise a liquid aqueous medium; an antimicrobial component in the aqueous liquid medium in an amount effective to disinfect a contact lens that comes into contact with the composition; a surfactant, preferably a non-ionic surfactant, a component in an amount effective to clean contact lenses that come into contact with the composition; a phosphate buffer component in an amount effective to maintain the pH of the composition within a physiologically acceptable range, an effective amount of a viscosity-inducing component; and an effective amount of a tonicity component. The present compositions preferably include an effective amount of a chelating or sequestering component, more preferably in a range of less than 0.05% (w / v). Each of the components, in the concentration used, included in the solutions and formulated solutions of the present invention are preferably ophthalmically acceptable. In addition, each of the components, in the used concentration included in the present solutions is preferably soluble in the liquid aqueous medium.

A SO1UCÍO | The component thereof is "ophthalmically acceptable" when it is compatible with the ocular tissue, that is, it does not cause significant or undue harmful effects when the eye is placed on the eye tissue, preferably, each component of the present compositions is also compatible with the eye tissue. The other components of the present compositions The present compositions are more preferably ophthalmically optimized substantially.Ophthalmically optimized composition is one which, within the restrictions of the chemistry of components, minimizes the ocular response or, conversely, provides an ophthalmic benefit to the eye of the wearer of the lenses. The currently useful antimicrobial components include chemicals which derive their antimicrobial activity through a chemical or physiochemical interaction with microbes or microorganisms, such as those that contaminate contact lenses. Suitable antimicrobial components are those generally used in ophthalmic applications and include, but are not limited to, quaternary ammonium salts used in ophthalmic applications such as poly [dimethylimino-2-butene-1,4-diyl] chloride, alpha-dichloride. [4-tris (2-hydroxyethyl) ammonium] (chemical registration number 75345-27-6, available under the trademark Polyquaternium 17 from Onyx Corporation), halides "'H-12-metal chlorites such as alkali metal chlorites and of alkaline earth metal, and the like, and mixtures thereof. Technical grade sodium chlorite is a very useful precursor of chlorine dioxide. Complexes containing chlorine dioxide such as complexes of chlorine dioxide with carbonate, chlorine dioxide with bicarbonate and mixtures thereof are also included as precursors of chlorine dioxide. The exact chemical composition of many chlorine dioxide precursors, eg, SCD and chlorine dioxide complexes, is not fully understood. The preparation or production of certain chlorine dioxide precursors is described in McNicholas U.S. Pat. 3,278,447, which is incorporated herein by reference in its entirety. Specific examples of useful SCD products include those sold under the trademark Dura Klor by Rio Linda Chemical Company, Inc., and those sold under the trade name Anthium Dioxide by International Dioxide, Inc. If a chlorine dioxide precursor is included. in the present compositions, it is preferably present in an effective disinfecting amount of contact lenses. Such effective disinfectant concentration is preferably in the range of about 0.002 to about 0.06% (w / v) of the present compositions. Such chlorine dioxide precursors can be used in combination with other SI-benzalkonium and biguanides, such as alexidine salts, alexidine free base, chlorhexidine salts, hexamethylene biguanides and their polymers, and salts thereof, antimicrobial polypeptides. , chlorine dioxide precursors and the like, and mixtures thereof. Generally, hexamethylene biguanide polymers (PHMB), also referred to as polyaminopropylbiguanide (PAPB), have molecular weights of up to about 100,000. Such compounds are known and described in Ogunbiyi et al, U.S. Pat. No. 4,758,595, the disclosure of which is incorporated herein by reference in its entirety. The antimicrobial components useful in the present invention are preferably present in the liquid aqueous medium in concentrations in the range of about 0.00001% to about 2% (w / v). More preferably, the antimicrobial component is present in the liquid aqueous medium at an ophthalmically acceptable or safe concentration so that the user can remove the disinfected lenses from the liquid aqueous medium and subsequently directly place the lens in the eye of the user, so that safe and comfortable. Suitable antimicrobial components for inclusion in the present invention include chlorine dioxide precursors. Specific examples of chlorine dioxide precursors include stabilized chlorine dioxide (SCD), antimicrobial components, such as biguanides, biguanide polymers, salts thereof and mixtures thereof. In the case where chlorine dioxide precursors are used as antimicrobial components, the compositions preferably have an osmolality of at least about 200 mOsmol / kg and are buffered to maintain the pH within an acceptable physiological range, for example, a range of from about 6 to about 10. In one embodiment, the antimicrobial component is non-oxidizing. It has been found that small amounts of non-oxidizing antimicrobial components, for example in a range of about 0.1 ppm to about 3 ppm or less than 5 ppm (w / v), in the present compositions are effective for disinfecting contact lenses and reducing contact lenses. risk of such antimicrobial components causing discomfort and / or eye irritation. Such a reduced concentration of antimicrobial component is very useful when the antimicrobial component that is used is selected from biguanides, biguanide polymers, salts thereof and mixtures thereof. When it is desired to disinfect a contact lens by the present compositions, an amount of the antimicrobial component effective to disinfect the lens is used. Preferably, such effective amount of component "Antimicrobial reduces the support or microbial load in contact lenses in a logarithmic order, in three hours. More preferably, an effective amount of the disinfectant reduces the microbial load in a logarithmic order in one hour. The phosphate buffer component is present in an amount effective to maintain the pH of the composition or solution in the desired range, for example, in a physiologically desirable range of about 4 or about 5 or about 6 to about 8 or about 9 or about 10. In particular, the solution preferably has a pH in the range of about 6 to about 8. The phosphate buffer component preferably includes one or more phosphate buffers, for example, combinations of monobasic phosphates, dibasic phosphates and Similar. Particularly useful phosphate buffers are those which are selected from alkali metal and / or alkaline earth metal phosphate salts. Examples of suitable phosphate buffers include one or more of sodium dibasic phosphate (Na2HP04), sodium monobasic phosphate (NaH2P04) and potassium monobasic phosphate (KH2P04). The present buffering components are often used in amounts ranging from about 0.01% or about 0.02% to about 0.5% (w / v), calculated as phosphate ion.

The present compositions preferably further comprise effective amounts of one or more additional components, such as a detergent or surfactant aldehyde; a viscosity or thickener inducing component, - a chelating or sequestering component; a tonicity component; and the like, and mixtures thereof. The additional component or components may be selected from materials which are known to be useful in contact lens care compositions and which are included in effective amounts. to provide the desired effect or benefit. When an additional component is included, it is preferably compatible under typical conditions of use and storage with the other components of the composition. For example, the additional component or components mentioned above Preferably they are substantially stable in the presence of the antimicrobial components and buffers described herein. A surfactant component is preferably present in an effective amount in the cleaner, so Which at least facilitates removal, and is preferably effective to remove debris or material deposited from a contact lens that contacts the surfactant-containing solution. Exemplary surfactant components include, but are not limited to, nonionic surfactants, example polysorbates (for example polysorbate 20 -brand "Js £££ kSé! SiB & ~~~ commercial Tween 20), polymers of 4- (l, 1, 3, 3-tetramethylbutyl) phenol / poly (oxyethylene) (such as the polymer sold under the trademark Tyloxapol ), block copolymers of poly (oxyethylene P * poly (oxypropylene), glycol esters of fatty acids and the like, and mixtures thereof The surfactant component is preferably nonionic, and is most preferably selected from block copolymers of poly (oxyethylene) -poly (oxypropylene) and mixtures thereof Such surfactant components can be obtained commercially from BASF Corporation under the tradename Pluronic 7. Such block copolymers can generally be described as finished polyoxyethylene / polyoxypropylene condensation polymers. in primary hydroxyl groups, these can be synthesized by first creating a hydrophobic of desired molecular weight by the controlled addition of propylene oxide to the two hydroxyl groups of In the second stage of the synthesis, ethylene oxide is added for the interposition of this hydrophobe between hydrophilic groups. According to a more preferred embodiment of the invention, such block copolymers having molecular weights in the range of about 2500 to 13,000 daltons are suitable, with a molecular weight range of about 6,000 to about 12,000 daltons being most preferred. Specific examples which are satisfactory include: poloxamer 108, poloxamer 188, poloxamer 237, poloxamer 238, poloxamer 288 and poloxamer 407. Particularly good results are obtained with polvaxer 237. The amount of surfactant component, if any, present, varies over a wide range depending on various factors, for example, the surfactant or specific surfactants that are used, the other components in the composition and the like. Frequently, the amount of surfactant is in the range of about 0.005% or about 0.01% to about 0.1% or about 0.5%, or about 0.8% (w / v). The viscosity-inducing components used in the present solutions are preferably effective at low or reduced concentrations, are compatible with the other components of the present solutions and are non-ionic. Such viscosity-inducing components are effective to improve and / or prolong the cleansing or wetting activity of the surfactant component and / or condition the surface of the lenses by rendering it more hydrophilic (less lipophilic) and / or to act as a demulsifier in the eye. An increase in the viscosity of the solution provides a film on the lens which can facilitate the comfortable use of the treated contact lenses. The viscosity-inducing component can also act to dampen the surface on the eye during insertion and serve as an "EGO"? to relieve eye irritation. Suitable viscosity-inducing components include, but are not limited to, natural water-soluble gums, cellulose-derived polymers and the like. Useful natural gums include guar gum, tragacanth gum and the like. Viscosity-inducing components, useful cellulose derivatives include cellulose-derived polymers, such as hydroxypropylcellulose, hydroxypropylmethylcellulose, carboxymethylcellulose, methylcellulose, hydroxyethylcellulose, and the like. More preferably, the viscosity inducing agent is selected from cellulose derivatives (polymers) and mixtures thereof. A very useful viscosity-inducing component is hydroxypropylmethylcellulose (HPMC). The viscosity-inducing component is used in an amount effective to increase the viscosity of the solution, preferably at a viscosity in the range of about 1.5 or about 30, or even as high as about 750 cps at 25 ° C, preferably determined by USP Test method No. 911 (USP 23, 1995). To obtain this range of viscosity increase, an amount of viscosity-inducing component of from about 0.01% to about 5% (w / v) is used, wherein amounts of about 0.05% to about 0.5% are more preferable. Preferably a chelating or sequestering component is included in an effective amount to improve the effectiveness of the antimicrobial component and / or to form complexes with metal ionics to provide more effective cleaning of contact lenses. A wide range of organic acids, amines or compounds which includes an acid group and an amine function, are capable of acting as chelating components in the present compositions. For example, nitrilotriacetic acid, diethylenetriaminepentaacetic acid, hydroxyethylethylenediamine triacetic acid, 1,2-diaminocyclohexane tetraacetic acid, hydroxyethylaminodiacetic acid, ethylenediaminetetraacetic acid and its salts, polyphosphates, citric acid and its salts, tartaric acid and its salts are useful as chelating components. similar, and mixtures thereof. Ethylenediaminetetraacetic acid (EDTA) and its alkali metal salts are preferred, with EDTA disodium salt, also known as disodium edetate, being particularly preferred. The chelating component is preferably present in an effective amount, for example, in a range of about 0.01% and about 1% (w / v) of the solution.

In a very useful moiety, particularly when the chelating component is EDTA, salts thereof and mixtures thereof, a reduced amount is used, for example, in the range of less than about 0.05% (w / v) or even about 0.02% (p / v) orders. Such reduced amounts of chelating component have been found to be effective in the present compositions while, at the same time, providing reduced discomfort and / or eye irritation. The liquid aqueous medium used is selected so as not to have a substantial harmful effect on the lenses being treated, or on the wearer of the treated lenses. The liquid medium is constituted to allow, and even facilitate the treatment or treatment of the lenses by the present compositions. Advantageously, the liquid aqueous medium has an osmolality in the range of at least about 200 mOsmol / kg for example, about 300 or about 350 to about 400 mOsmol / kg. The liquid aqueous medium is more preferably substantially isotonic or hypertonic (eg, slightly hypertonic) and / or ophthalmically acceptable. The liquid aqueous medium preferably includes an effective amount of a tonicity component to provide the liquid medium with the desired tonicity. Such tonicity components may be present in the liquid aqueous medium and / or may be introduced into the aqueous medium liquid. Among the suitable tonicity adjusting components that can be used are those conventionally used in contact lens care products, such as various inorganic salts. Sodium chloride and / or potassium chloride and the like are very useful tonicity components. The amount of tonicity component included is effective to provide the desired degree of tonicity to the solution. Such amount may be, for example, in the range of from about 0.4% to about 1.5% (w / v). If a combination of sodium chloride and potassium chloride is used, it is preferred that the weight ratio of sodium chloride to potassium chloride be in the range of from about 3 to about 6 or about 8. Methods for treating lenses of contact using the compositions described herein are included within the scope of the invention. Such methods comprise contacting a contact lens with such a composition under effective conditions to provide the desired treatment for the contact lens. The preferred contact temperature is in the range of about 0 ° C to about 100 ° C, and more preferably in the range of about 10 ° C to about 60 ° C and still much more preferably in the range from approximately 15 ° C to * ~ w approximately 30 ° C. The contact at room temperature or at approximately the same temperature is very convenient and useful. The contact preferably occurs at or approximately atmospheric pressure. The contact preferably occurs for a time in the range of about 5 minutes or about 1 hour to about 12 hours or more. Contact lenses can be brought into contact with the liquid aqueous medium by immersing the lenses in the medium. During at least a portion of the contact, the liquid medium containing the contact lenses can be agitated, for example, by stirring the container containing the liquid aqueous medium and the contact lenses, to at least facilitate the removal of the material. of deposit of the lenses. After such a contacting step, the contact lenses can be manually rubbed to further remove material deposited from the lenses. After such a contacting step, the contact lenses can be manually rubbed to remove additional deposit material from the lenses. The cleaning method may also include rinsing the lenses substantially free of the liquid aqueous medium before returning the lenses to the eye of the wearer. The following non-limiting examples illustrate certain aspects of the present invention.

EXAMPLE 1 A solution is prepared by combining the following components together: PHMB 1 ppm (w / v) (polyhexamethylene biguanide) Disodium EDTA 0.02% (w / v) Poloxamer 237 0.05% (w / v) Poly (oxyethylene) -poly (oxypropylene) block copolymer Sodium dibasic phosphate (heptahydrate) 0.12! (p / v) Sodium monobasic phosphate (monohydrate) 0.01% (w / v) HPMC (Hydroxypropylmethylcellulose) 0.15% (w / v) Sodium chloride 0.79% (w / v) Potassium chloride 0.14% (w / v) Water (USP) QS 100% Approximately three (3) ml of this solution is placed in a lens bottle containing a lipid lens, filled with an oily, hydrophilic deposit or soft contact lens. Contact lenses are kept in this solution at room temperature for at least about four (4) hours. This treatment is effective to be found that briefly present in the lenses has been removed. This shows that this solution has substantial passive cleaning capability of contact lenses. Passive cleaning refers to cleaning which occurs during the soaking of contact lenses without mechanical or enzymatic improvement. After this time, the lenses are removed from the solution and placed in the user's eye of the lenses for safe and comfortable use. Alternatively, after the lenses are removed from the solution, they are rinsed with another quantity of this solution and the rinsed lenses are then placed in the eye of the lens holder for safe and comfortable use.

EXAMPLE 2 Example 1 is repeated, except that the lenses are rubbed and rinsed with a different amount of solution before being placed in a lens bottle. After at least approximately four (4) hours, the lenses are removed from the solution. The lenses are then placed in the eyes of the lens holder for safe and comfortable use.

EXAMPLE 3 The one of Example 1 is used as a long term soaking medium for hydrophilic contact lenses. Therefore, approximately three (3) ml of this solution is placed in a bottle and contact lenses are kept at room temperature for approximately sixty (60) hours. After this period of soaking, the lenses are removed from the solution and placed in the eyes of the lens holder for safe and comfortable use. Alternatively, after the lenses are removed from the solution, they are rinsed with another quantity of this solution and the rinsed lenses are then placed in the eyes of the lens holder for safe and comfortable use.

EXAMPLE 4 Hydrophilic contact lenses ready for use. In order to facilitate such use, one or two drops of the solution of Example 1 are placed on the lenses immediately before their placement of the lenses in the eyes of the lens wearer. The holder of these lenses is comfortable and safe.

An illiza ported contact lens applies one or two drops of a solution of Example 1 to the eye where the lens is located. This effects a rewet of the lenses and provides a comfortable and safe use of the lenses.

EXAMPLE 6 A series of tests are carried out to evaluate the comfort, safety and acceptability of the solution prepared according to Example 1 in comparison with the other two solutions. The first of these other additional solutions, referred to below as composition A, is sold under the trade name ReNu7 by Bausch & Lomb and includes 0.5 ppm of PHMB, ethylenediamine surfactant substituted with poly (oxyethylene) -poly (oxypropylene), a borate buffer system, 0.1% disodium EDTA, and sodium chloride as a tonicity agent. The second of these other solutions, referred to below as composition B, is similar to the composition of Example 1, except that composition B includes 0.6% (w / v) tromethamine and none of the phosphates.

Each of these compositions is tested for less a commercially available multi-purpose solution. The study is a randomized study, double three-way masking. The study is broken down into a series of treatment periods of three (3) one (1) months. Each of the compositions is used on a daily basis for cleaning, rinsing after cleaning, disinfecting and rinsing before application of the lenses, as needed. Because each treatment period is only one (1) month in duration, an enzymatic cleanser is not used in this study. The subjects are evaluated on day zero (baseline) on day seven (7) and on day thirty (30) for each of the three (3) treatment periods. The primary variables of comfort and acceptability are the ease of use of the lenses and the preference of the product at the end of the study. The primary safety variable is the findings of the examination as a slot lamp. 123 subjects are enrolled. An amount of 116 (94.3%) complete the preference questionnaires for period 2 33S * í of treatment. An amount of 118 (95.9%) complete the questionnaires. The slotted lamp examination indicates that each of the tested compositions is acceptably safe. The comfort and acceptability results included in this summary are based on subjective responses to selected questions (at the end of periods 2 and 3 of treatment). Additional tabulations are made based on subjective responses to the selected questions indicated above, as well as other questions included in the preference questionnaires. These tabulations are made using answers from the questionnaires of preference for period 3 of treatment. The results of these additional tabulations are as follows: Presumed reference Answers where is Answered where is No preference Value P prefers composition prefers composition A of Example 1 5? % General pretense 65 28 7 0 02 Preference in the hand 56 27 17 0 02 Preference in the eye 63 27 1 1 0 02 Comfort in the eye 60 25 15 0 02 Amount of time for the lenses to settle in the eye 47 21 32 0 02 Maintenance of wet lenses in the eyes 55 28 17 0.02 Maintenance of lubricated lenses in the eyes 57 28 15 0.02 Stitches in the eyes 57 27 16 0.02 • BASED ON A P VALUE OF 0.02, THESE RESULTS ARE SIGNIFICANT AT A LEVEL OF 95% CONFIDENCE Reference question Answers where answers Preferred answers No preference Value P prefers composition B Composition A of Composition% General preference 55 40 5 0.18 Preference in the hand 51 31 18 0.08 Preference in the eye 60 34 6 0.02 Comfort in the eye 36 34 10 0.06 Amount of time for the lenses to settle in the eye 44 31 25 0.26 Maintenance of the wet lenses in the eyes 47 34 19 0.26 Maintenance of the lubricated lenses in the eyes 47 32 21 0.18 Stitches in the eyes 57 32 10 0.02 These results indicate a clear preference for the composition of Example 1 over composition A; and a general preference for the composition of Example 1 over composition B.

These results themselves are surprising since composition A is a commercially available multiple purpose solution. Possible reasons for the preference of the composition of Example 1 in relation to composition A include one or more of the presence of HPMC, the presence of a poly (oxyethylene) -poly (oxypropylene) block copolymer surfactant, the presence of phosphate buffer, and / or the presence of a reduced amount of EDTA.

EXAMPLE 7 A solution containing 1 ppm (0.0001% (w / v)) of polyhexamethylene biguanide (PH B), 0.02% (w / v) of EDTA, 0.05% is distributed in a set of tubes, of 8 ml per tube (w / v) of poloxamer 237, 0.15% (w / v) of hydroxypropylmethylcellulose (HPMC), 0.12% (w / v) of sodium dibasic phosphate, 0.01% (w / v) of monobasic sodium phosphate, 0. 79% (w / v) of sodium chloride and 0.14% (w / v) of potassium chloride. Each tube is supplied with an initial inoculation of one of the organisms included in the Table below. The tubes are allowed to incubate for 24 hours at 32 ° C, taking aliquots of each tube at 1, 2, 3, 4 and 24 hours. A negative control contains a physiological saline solution inoculated with each test organism. In each aliquot, PHMB is neutralized by adding 1 ml of the test solution to 9 ml of Le h ^ n broth. Letheen broth contains lecithin and TWEEN "R 80, a non-ionic surfactant, - these ingredients form micelles around PHMB which renders it inactive without having a harmful effect on the test bacteria and fungi Serial dilutions of the aliquot are made neutralized and the dilutions plated in Petri dishes containing either tryptic soy agar (bacteria) or Sabouraud dextrose agar (fungi), allowing 0 plates to incubate for 48 hours, and then counting the number of colonies. The number of viable cells in each aliquot after incubation with the test solution is determined by multiplying the number of colonies obtained in the culture plates between the dilution factor.The comparison of the number of colonies (viable cells) in each tube and the time point with the negative control provides the data contained in the Table below. Étíí ^ iÉí As the data demonstrate, substantial microbicidal activity is provided by the solutions of the present invention. These compositions provide a very beneficial and advantageous combination of operating efficiency and comfort and acceptability of the lens wearer / user. In the context of contact lens care solutions, the comfort and acceptability of the lens wearer / user is very important. For example, to promote a regular and effective treatment of contact lenses. Such treatment of contact lenses ultimately promotes eye health and reduces the frequency of problems caused by the use of contact lenses. Therefore, the comfort and acceptability of the lens wearer / wearer are of substantial importance and benefit in a contact lens care product, particularly in the present compositions which show substantial comfort and acceptability, and even improved , of the lens holder / user. Although this invention has been described with respect to various specific examples and embodiments, it should be understood that the invention is not limited thereto and that it may be practiced in various ways within the scope of the following claims. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is the conventional one for the manufacture of the objects or products to which it refers.

Claims (20)

1. Having described the invention as above, the content of the following claims is claimed as property: l. A multi-purpose solution for the care of contact lenses, characterized in that it comprises: an aqueous liquid medium, - an antimicrobial component in an amount effective to disinfect contact lenses that come into contact with the solution, the non-oxidative antimicrobial component is selects from the group consisting of biguanides, biguanide polymers, salts thereof and mixtures thereof, and is present in an amount in a range of about 0.1 ppm to about 3 ppm, - a poly block copolymer surfactant. oxyethylene) -poly (oxypropylene) in an amount effective to clean contact lenses that come in contact with such a solution; a phosphate buffer component in an amount effective to maintain the pH of the solution within a physiologically acceptable range, - a viscosity-inducing component that is selected from the group consisting of cellulose derivatives and mixtures thereof in an effective amount in a range from about 0.05% to about 0.5% (w / v); a chelating component in an effective amount of less than 0.05% (w / v); and a tonicity component in an amount effective to provide the desired tonicity to the solution.
2. 2. The multi-purpose solution, according to claim 1, characterized in that the antimicrobial component is selected from the group consisting of polyhexamethylene biguanide, salts thereof and mixtures thereof.
3. 3. The multi-purpose solution, according to claim 1, characterized in that the surfactant is present in an amount ranging from about 0.01% to about 0.8% (w / v).
4. 4. The multi-purpose solution according to claim 1, characterized in that the phosphate buffer component includes a combination of sodium acid phosphate and sodium diacid phosphate.
5. 5. The multi-purpose solution, according to claim 1, characterized in that the * S £. The phosphate buffer component is present in an amount ranging from about 0.01% to about 0.5% (w / v).
6. 6. The multi-purpose solution, according to claim 1, characterized in that the viscosity-inducing component is hydroxypropylmethylcellulose.
7. 7. The multi-purpose solution according to claim 1, characterized in that the tonicity component includes a combination of sodium chloride and potassium chloride and is present in a range from about 0.4% to about 1.5% (w / v).
8. 8. The multiple purpose solution, according to claim 1, characterized in that the chelating component is EDTA.
9. 9. A multi-purpose solution for the care of contact lenses, characterized in that it comprises: an aqueous liquid medium, - an antimicrobial component that is selected from the group consisting of biguanides, biguanide polymers, salts thereof and mixtures thereof , and that is present in an amount in a range from about 0.1 ppm to less than 5 ppm; a surfactant component in an amount effective to clean contact lenses that come into contact with the solution; a phosphate buffer component in an amount effective to maintain the pH of the solution within a physiologically acceptable range, - a viscosity-inducing component in an amount effective to increase the viscosity of the solution, - and a tonicity component in a effective amount to provide the desired tonicity to the solution.
10. 10. The multi-purpose solution, according to claim 9, characterized in that the antimicrobial component is selected from the group consisting of polyhexamethylene biguanide, salts thereof and mixtures thereof.
11. 11. The multiple purpose solution according to claim 9, characterized in that the viscosity inducing component is hydroxypropylmethylcellulose.
12. 12. The multi-purpose solution, according to claim 9, characterized in that the surfactant is selected from the group consng of poly (oxyethylene) -poly (oxypropylene) block copolymers and mixtures thereof, and is present in an amount in a range of about 0.01% to about 0.8% (w / v).
13. 13. The multi-purpose solution, according to claim 9, characterized in that the tonicity component includes a combination of sodium chloride and potassium chloride, and is present in a range from about 0.4% to about 1.5% (w / v) .
14. 14. The multi-purpose solution, according to claim 9, characterized in that it also comprises an effective amount of EDTA in a range of less than 0.05% (w / v).
15. 15. A multi-purpose solution for the care of contact lenses, characterized in that it comprises: an aqueous liquid medium, - an antimicrobial component in an amount effective to disinfect contact lenses that come into contact with the solution; a surfactant component in an amount effective to clean contact lenses that come in contact with the solution, - a phosphate buffer component in an amount effective to maintain the pH of the solution within a physiologically acceptable range; a viscosity-inducing component which is selected from the group consng of cellulose derivatives and mixtures thereof and which is present in an effective amount in a range from about 0.05% to about 0.05% (w / v); a chelating component in an effective amount of less than 0.05% (w / v); and a tonicity component in an amount effective to provide the desired tonicity to the solution.
16. 16. The multi-purpose solution, according to claim 15, characterized in that the viscosity-inducing component is hydroxypropimethylcellulose.
17. 17. The multi-purpose solution, according to claim 15, characterized in that the chelating agent is EDTA. ? »'" §É ~ 2 *
18. 18. The multi-purpose solution, according to claim 15, characterized in that the antimicrobial component is selected from the group consng of biguanides, biguanide polymers, salts thereof and mixtures thereof, and is present in an amount in a range from about 0.1 ppm to less than 5 ppm.
19. 19. The multi-purpose solution, according to claim 18, characterized in that the antimicrobial component is selected from the group consng of polyhexamethylene biguanide, salts thereof and mixtures thereof.
20. 20. The multi-purpose solution, according to claim 15, characterized in that the surfactant is present in an amount ranging from about 0.1% to about 0.8% (w / v).