JP2019020730A - Multifocal soft contact lens - Google Patents

Abstract

To achieve a multifocal soft contact lens that is effective for progress prevention or treatment of a near sight or a posterior ocular disease.SOLUTION: A multifocal soft contact lens, which is used for progress prevention or treatment of a near sight or a posterior ocular disease, is provided that comprises an optical part that has a center area with a far vision-purpose first lens diopter, and a peripheral area to be arranged outside the center area and with a second lens diopter, in which light ray transmittance ranging from 360nm to 400nm of a wavelength in the optical part stands 70% to 100%.SELECTED DRAWING: Figure 3

Description

  The present invention relates to a multifocal soft contact lens used for preventing or treating the progression of myopia or posterior eye diseases.

  There is a racial difference in the frequency of myopia. In particular, there are many Asians, especially Japanese people who have a lot of myopia, and a high rate of myopia of -6D (diopter) or higher. In recent years, myopia has been increasing worldwide, and the percentage of children with naked eyesight less than 1.0 is increasing year by year in Japan. It is also known that myopia rapidly progresses from 7 to 12 years of school age (Non-Patent Document 1).

  Myopia is classified into refractive myopia, regulatory myopia (pseudomyopia), and axial myopia depending on the onset mechanism, but myopia in schoolchildhood is mainly axial myopia. The human eye is hyperopic immediately after birth, and the degree of hyperopia is reduced by the extension of the eye axis during the growth period, and becomes normal when entering the school age. The extension of the eye axis after this normalization phenomenon leads to myopia as it is, and the length of the eye axis once extended cannot be restored. Therefore, it is considered that the suppression of the extension of the eye axis during the period from the growth period to the schoolchildhood is effective for the prevention or treatment of myopia (Non-Patent Document 2). Also, the eye axis extends not only in the growth period but also in adults. Adult eye extension is said to be a risk factor for various eye diseases.Intense myopia resulting from excessive eye extension is a complication of cataract, glaucoma, retinal detachment, retinopathy, macular disease, Increases the risk of ocular diseases such as choroidal neovascularization, posterior staphyloma, or optic neuropathy (Non-Patent Document 2). Therefore, suppression of axial extension can not only lead to QOL improvement by preventing myopia, but can also lead to prevention of serious eye diseases that lead to blindness.

  Various methods have been studied for suppression of this myopia progression (excessive eye extension). A meta-analysis of the results of past clinical studies on the suppression of the axial extension of the eye, statistically significant in the axial length in the order of atropine eye drops, pirenzepine ointment, orthokeratology, peripheral defocused glasses, progressive multifocal glasses The inhibitory effect was shown. However, there are still problems to be solved such as side effects seen in instillation of atropine, cost burden in orthokeratology, complexity of means, and limited effect on wearing glasses (non-patent) Reference 3).

  In addition, research on the risk factors of this myopia progression (axial extension) is progressing, and it is said that age, sex, heredity, society and living environment, etc. are correlated with axial extension (see Non-Patent Document 4). reference). In particular, the increase in near-term work (reading and writing, VDT (Visual Display Terminals) work), the accompanying generation of adjustment lag, and insufficient exposure to sunlight (particularly 360-400 nm violet light) are attracting attention as risk factors for eye extension. (See Non-Patent Document 5). In addition, when myopia is completely corrected with a single focus lens, focal shift (peripheral defocus) occurs in the peripheral part of the retina, and it is said that the peripheral defocus is a signal of eye axis extension. It will progress further. In modern Japanese society, it is difficult to change the main lifestyle indoors such as studying, reading, VDT work, etc., a method of suppressing myopia progression even in a living environment where there are many such near work tasks and violet light exposure is poor Is required.

  In recent years, methods for suppressing the progression of myopia using contact lenses have been studied, and it has been reported that the adjustment lag and peripheral defocus are removed by a multifocal soft contact lens, and axial extension is suppressed. However, the existing multifocal soft contact lens does not have a sufficient effect of suppressing myopia progression, and the quality of vision (QOV) is inevitably deteriorated due to high-order aberration due to multifocal (non-patent literature). 6). There is a need for a multifocal soft contact lens for preventing myopia that improves the quality of view and optical stability, which are the problems of conventional multifocal soft contact lenses.

  Further, in recent years, eye damage due to ultraviolet exposure has been regarded as a problem, and many contact lenses contain UV absorbers (Non-patent Document 7). Although UV absorbers are beneficial in terms of cutting harmful ultraviolet rays, they also cut excessively to visible light (violet light) in the vicinity of ultraviolet rays (near 380 nm), which promotes the progression of myopia. It is also said. Sufficient exposure to violet light is important for the prevention of myopia, and it is necessary to appropriately adjust the type and content of the UV absorber.

Ryo Kawasaki, Kyoko Ohno, “Increasing Myopia / Intensity Myopia”, History of Medicine, 2015, Vol. 253, no. 2, p. 159-161 Hidenori Torii, “Intensity myopia from the viewpoint of aging”, 2016, Ophthalmology, Vol. 58, no. 6, p. 635-641 Satoshi Hasebe, “Strategy for suppressing myopia progression and suppression of eye extension in schoolchildren”, Ayumi Medicine, 2013, Vol. 245, no. 10, p. 880-884 Tai Liang Lu et al., “Axial Length and Associated Factors in Children: The Shandong Children Eye Study” Ophthalmologica, 2016, Vol.235, p.78-86 By Tsubota Kazuo, “Your child will be myopic if it is as it is”, Discover Twentyone Publishing, February 2017 Sayuri Ninomiya, “Prevention of myopia progression by CL”, MB OCULL, 2013, No. 4, p. 67-74 Linda Moore et al., “Ultraviolet (UV) transmittance characteristics of daily disposable and silicone hydrogel contact lenses.” Contact Lens & Anterior Eye, 2006, Vol.29, p.115-122

  An object of the present invention is to provide a multifocal contact lens effective for preventing or treating myopia or posterior segment disease.

  It is well known that environmental factors and genetic factors are related to the onset of myopia. Recently, outdoor life and activities have decreased, and indoor life and activities have increased, and smartphones, game consoles, personal computers, LCD TVs, etc. have become popular in a wide range of ages from children to the elderly. It has become a living environment for long-term use, and the increase in short-term work that causes nearsightedness and the shortage of exposure to violet light due to indoor work are getting worse. From such a background, a method that leads to myopia prevention is strongly demanded.

  An object of the present invention is to provide a multifocal contact lens effective for the prevention or treatment of myopia or eye diseases. In particular, there is an increased risk of eye diseases such as cataracts, glaucoma, retinal detachment, retinopathy, macular disease, choroidal neovascularization, posterior staphylococci or optic neuropathy, as well as growing children and young people who develop and progress myopia The object is to provide a multifocal contact lens that is effective for middle-aged and older people.

  As a result of various studies conducted by the present inventors in order to solve the above-mentioned problems, myopia is suppressed by suppressing the extension of the eye axis by wearing a multi-focal soft contact lens that is sufficiently transmitted through the violet light and whose central region is far away. It has been found that the progress of can be suppressed, and the present invention has been completed.

That is, the present invention provides the following soft contact lenses.
[1] A multifocal soft contact lens used for preventing or treating the progression of myopia or posterior eye diseases,
A central region having a first lens power for distance vision;
An optical unit having a second lens power and a peripheral region disposed outside the central region;
The multifocal soft contact lens whose light transmittance from wavelength 360nm to 400nm in this optical part is 70%-100%.
[2] The multifocal soft contact lens according to [1], wherein the dynamic friction coefficient of the lens is 0.1 to 2.4.
[3] The multifocal soft contact lens according to [1] or [2], wherein the maximum compression strength from the front surface of the lens in the optical axis direction is 3 to 5 g.
[4] The multifocal soft contact lens according to any one of [1] to [3], wherein a material of the lens is a silicone hydrogel or a non-silicone hydrogel.
[5] The silicone hydrogel is a comfilcon, an enfilcon, an asmofilcon, a delefilcon, an efrofilcon, a samfilcon, a fanfilcon. Multifocal according to [4], which is at least one selected from the group consisting of stenfilcon, stenfilcon, somofilcon, narafilcon, galyfilcon, and senofilcon Soft contact lens.
[6] The non-silicone hydrogel comprises metafilcon, omafilcon, tetrafilcon, ocufilcon, nelfilcon, nefilcon, femfilcon The multifocal soft contact lens according to [4], which is at least one selected from the group consisting of polymacon, polymacon, hilafilcon, nesofilcon, and etafilcon.

  The present invention provides a multifocal soft contact lens that is effective for preventing or treating myopia or posterior eye disease progression.

FIG. 1 is a diagram showing a configuration of a multifocal soft contact lens according to an embodiment of the present invention. FIG. 2 is a diagram showing a configuration of a multifocal soft contact lens according to another embodiment of the present invention. FIG. 3 is a graph showing the results of a dynamic friction coefficient evaluation test in an example according to the present invention and a comparative example. FIG. 4 is a graph showing the results of compressive strength evaluation tests in Examples and Comparative Examples according to the present invention. FIG. 5 is a graph showing the results of the light transmittance evaluation test in Examples and Comparative Examples according to the present invention. FIG. 6 is a graph showing an evaluation test of near-field side adjustment fine movement in an example according to the present invention and a comparative example.

  Hereinafter, an example of a multifocal contact lens according to an embodiment of the present invention will be described with reference to the drawings. In addition, this invention is not limited to the following examples. 1 to 2, the dimensional ratios of the drawings do not necessarily match the actual dimensional ratios, and the dimensional ratios between the drawings do not necessarily match.

  FIG. 1 shows a schematic configuration of a multifocal soft contact lens according to an embodiment of the present invention. A multifocal soft contact lens 1 according to an embodiment of the present invention includes an optical part 2 and an edge part 5. The optical unit 2 is configured to have a predetermined refractive power. The edge part 5 is related to the contact property to the eyeball when the multifocal soft contact lens is worn.

  The multifocal soft contact lens 1 according to the present embodiment is formed to have a diameter of 7 to 18 mm, preferably has a diameter of 10 to 16 mm, more preferably has a diameter of 12 to 15 mm, and particularly preferably has a diameter of 13 to 13 mm. It is formed to be 14.5 mm. The optical unit 2 is formed to have a diameter of φ5 to 16 mm, preferably a diameter of φ8 to 14 mm, more preferably a diameter of φ10 to 13 mm, and particularly preferably a diameter of φ11 to 13 mm. Has been.

  In addition, the multifocal soft contact lens 1 according to the present embodiment is formed of a disk-shaped member, and the wearing surface on the eyeball is formed in a concave shape. In another embodiment, the multifocal soft contact lens 1 may be configured by an elliptical member.

  In the multifocal soft contact lens 1 according to the present embodiment, the optical unit 2 has a central region 3 and a peripheral region 4 formed concentrically in order from the center.

  The central region 3 has a first lens power that is for far vision. In the multifocal soft contact lens 1 according to the present embodiment, a light beam from a distance that enters the eye through the central region 3 forms a focal point on the retina by the first lens power.

  The central region 3 is a region used for viewing from a distance, and is formed on a circle at the center of the multifocal soft contact lens 1. The diameter of the central region 3 is formed to have a radius of 0.5 to 3.5 mm from the viewpoint of appropriately preventing or treating the progression of myopia or posterior eye diseases.

  In the central region 3, a desired refractive power (distance diopter, minus diopter) is used from the viewpoint that a light ray incident from a distance can appropriately form a focal point on the retina. This refractive power is set in the same manner as the distance power used in ordinary soft contact lenses.

  The refractive power in the central region 3 is such that the amount of change in spherical aberration (difference between the maximum value and the minimum value) in the range where the light incident height is 0 to 1.5 mm is 0. It is preferably set to be within 3 mm.

  The peripheral area 4 has a second lens power and is arranged outside the central area 3. In the multifocal soft contact lens 1 according to the present embodiment, light rays that enter the eye through the peripheral region 4 form a focal point on the retina by the second lens power.

  In the peripheral region 4, a desired addition power is used with respect to the first lens power from the viewpoint of exerting an effect of suppressing the adjustment lag and peripheral defocus due to the multifocal structure. The addition power is preferably 0.5 to 3.0D (diopter), more preferably 0.5 to 2.5D, still more preferably 0.5 to 2.0D, and particularly preferably 0.5 to 1.5D. The addition power used for the second lens power is appropriately set depending on the peripheral defocus symptom of the wearer.

  The peripheral region 4 is set to have a predetermined width from the viewpoint that incident light rays can appropriately form a focal point on the retina. The width of the peripheral region 4 is not limited, but is formed to be 0.2 to 3 mm, and preferably 0.5 to 2 mm.

  The second lens power in the peripheral region 4 is the amount of change in spherical aberration in the range of the incident light height of 2.5 to 3.5 mm from the viewpoint of exhibiting the effect of suppressing the adjustment lag and peripheral defocus due to the multifocal structure. The difference between the maximum value and the minimum value is preferably set to be within 0.5 mm.

  In the multifocal soft contact lens 1 according to the present embodiment, the light transmittance in the optical unit 2 ranging from a wavelength of 360 nm to 400 nm is 70% to 100%. Although not limited, the multifocal soft contact lens 1 according to the present embodiment preferably has a light transmittance of 80% to 100%, and 90% to 100% in the optical section 2 over a wavelength range of 360 nm to 400 nm. Is more preferably 95% to 100%, and particularly preferably 96.5% to 100%. In this specification, “ranging from a wavelength of 360 nm to 400 nm” is synonymous with “in the entire wavelength region of a wavelength of 360 nm to 400 nm”.

  Since the multifocal soft contact lens 1 according to the present embodiment is designed to have a high light transmittance in the optical unit 2 from a wavelength of 360 nm to 400 nm, the violet light can be sufficiently exposed to the eyeball. For this reason, the multifocal soft contact lens 1 which concerns on this embodiment can suppress ocular extension, and can be used for the progress prevention or treatment of myopia. In addition, the multifocal soft contact lens 1 according to the present embodiment suppresses the intensity of myopia resulting from excessive extension of the axial axis by suppressing the extension of the axial axis, resulting in glaucoma, retinal detachment, and retinopathy as complications. It can be used for the prevention or treatment of progression of posterior ocular diseases such as macular disease, choroidal neovascularization, posterior staphyloma or optic neuropathy.

  In this specification, the light transmittance of the soft contact lens over the wavelength range from 360 nm to 400 nm is determined by taking ISO soft saline (sodium chloride: 0.83 w / v%, phosphoric acid) after removing the soft contact lens from the package and draining it. Sodium hydride dodecahydrate: 0.5993 w / v%, sodium dihydrogen phosphate dihydrate: 0.0528 w / v%), and a 12-well plate dispensed with 5 ml of ISO physiological saline. Store the lens in at room temperature for 1-3 days. Excess moisture from the contact lens is wiped, the cell is held in the contact lens holder, and measurement is performed using a TM-1 spectral transmittance meter manufactured by TOPCON. Next, the transmittance at intervals of 5 nm is output to the PC, and the average value of each transmittance is calculated as the light transmittance ranging from 360 nm to 400 nm, and the exposure amount of violet light that is known to bring about the progression prevention of myopia As an indicator of

  In addition, as long as the light transmittance from wavelength 360nm to 400nm becomes 70% or more, you may contain the component in connection with the transmittance | permeability of violet lights, such as a ultraviolet absorber. From the viewpoint of remarkably exhibiting the effects of the present invention, the multifocal soft contact lens 1 according to the present embodiment preferably does not contain an ultraviolet absorber.

  The multifocal soft contact lens 1 is preferably colorless in order to increase the light transmittance from the wavelength 360 nm to 400 nm in the optical part 2, but the light transmittance from the wavelength 360 nm to 400 nm in the optical part 2 is 70% or more. As long as it is necessary, it may contain a colorant necessary as a contact lens. Examples of such a colorant include phthalocyanine colorants.

  The multifocal soft contact lens 1 according to the present embodiment is preferably formed so that the coefficient of dynamic friction is 0.1 to 2.4, more preferably 0.1 to 2.0, and 1-1.5 are more preferable, 0.1-1.0 are still more preferable, 0.1-0.8 are especially preferable, and 0.1-0.7 are the most preferable. In order to sufficiently expose the violet light to the eyeball and to exhibit the effect of suppressing the adjustment lag and peripheral defocus due to the multifocal structure, the multifocal soft contact lens 1 according to the present embodiment appropriately It is required that the optical axis is stabilized by moving in accordance with the blinking movement.

  When wearing a soft contact lens, it is optimal that the lens and cornea be concentric (centering), but the allowable movement of the lens depends on the lens physical properties, and if it is a soft lens, the movement may be small. On the contrary, if it is a hard lens, a certain degree of movement will cause keratoconjunctival disorder.

  In the case of a multifocal soft contact lens for removing defocusing at the periphery of the retina, the stability of the optical axis is critically important, and this centering and adjustment of the movement of the lens are required more strictly.

  When the material forming the multifocal soft contact lens 1 according to the present embodiment is a silicone hydrogel, although it is suitable as a multifocal soft contact lens for the purpose of preventing the progression of myopia requiring long-term wearing, In the first generation of silicone hydrogel soft contact lenses, due to their physical properties (hardness, high friction), there is no choice but to allow some movement to avoid keratoconjunctival damage. The stability of the optical axis may be insufficient. Although it is possible to stabilize the optical axis by using such a hard and high-friction soft contact lens as a tight fitting, a hard and non-slip (high friction) soft contact lens adheres to the keratoconjunctiva. When using a silicone hydrogel soft contact lens as a multifocal CL for preventing myopia, the softness (compressive strength from the front of the lens in the direction of the optical axis) and the coefficient of dynamic friction are particularly important. It is preferable to ensure a low value.

  In the present embodiment, the dynamic friction coefficient of the soft contact lens is measured according to the following protocol.

  After removing the soft contact lens from the package and draining it, the ISO physiological saline (sodium chloride: 0.83 w / v%, sodium hydrogenphosphate 12 hydrate: 0.5993 w / v%, sodium dihydrogen phosphate) 2 hydrate: 0.0528 w / v%) and store the lenses in 12-well plates dispensed with 5 ml of ISO saline for 1-3 days at room temperature. Thereafter, a soft contact lens is adhered to the contact of a friction tester (Tribomaster TL201Ts, manufactured by Trinity Lab). On the other hand, artificial leather is affixed to a moving table of a friction tester, and 15 mL of physiological saline is spread on the artificial leather so that the contactor can be sufficiently distributed over the entire surface. Next, a 50 g weight is attached to the measurement unit. A contact to which a soft contact lens is bonded is attached to a measurement unit and moved on the artificial leather at a speed of 2.0 mm / second. Measurement is performed 100 times per second for 20 seconds. The value obtained by subtracting the dynamic friction coefficient before measurement from the dynamic friction coefficient 10 seconds after the start of movement is calculated as the dynamic friction coefficient (μk) of the contact lens. It is used as an index of optical stability of contact lenses.

  In the multifocal soft contact lens 1 according to the present embodiment, the multifocal soft contact lens 1 according to the present embodiment is moderately soft (compression strength in the optical axis direction from the lens front surface) from the viewpoint of optical axis stabilization. It is necessary to have If the maximum compression strength from the front of the lens in the direction of the optical axis is too low, the soft contact lens will be displaced due to blinking or eyeball movement, causing the optical axis to become unstable, and if the maximum value is too high, the soft contact lens Since it can damage the keratoconjunctiva by adhering to the keratoconjunctiva, it is preferably 3 to 5 g, more preferably 3 to 4.5 g, and even more preferably 3 to 4 g.

  In this specification, the maximum value of the compressive strength in the optical axis direction from the front surface of the contact lens is measured by a measuring instrument: texture analyzer (manufactured by Eiko Seiki Co., Ltd.) TA. XT. Using plus TEXTURE ANALYSER, it is measured according to the procedure attached to the measuring instrument. Specifically, the maximum value of compressive strength in the optical axis direction from the front surface of the lens is measured by the following procedure.

  After removing the soft contact lens from the package and draining it, the ISO physiological saline (sodium chloride: 0.83 w / v%, sodium hydrogenphosphate 12 hydrate: 0.5993 w / v%, sodium dihydrogen phosphate) 2 hydrate: 0.0528 w / v%) and store the lenses in 12-well plates dispensed with 5 ml of ISO saline for 1-3 days at room temperature. This contact lens is placed with the lens front facing upward on the bottom of a plastic petri dish filled with physiological saline. Adjust so that the center of the probe of the measuring instrument matches the center of the contact lens, and start the measurement.

Texture analyzer TA. XT. The setting of plus TEXTURE ANALYSER is as follows.
Test mode: Compression measurement Probe type: φ10mm cylinder probe Target Mode: Distance
Distance: 2.5mm
Trigger Type: Auto
Trigger Force: 0.1g
Test Speed: 1.0mm / sec

  After the probe starts to push down the apex of the contact lens from the front surface in the optical axis direction, the compressive strength when crushing the lens of 2.5 mm (2.5 seconds) is measured, and the maximum value is recorded as the maximum compressive strength value.

  As a material constituting the multifocal soft contact lens 1 according to the present embodiment, various polymerizable lens forming preparations are used. As such a material, a hydrous material is preferable, and hydrogel is suitably used. In view of remarkably exhibiting the effects of the present invention, the material is particularly preferably a silicone hydrogel. Silicone hydrogels are based on polymerizable lens-forming formulations containing siloxane monomers, oligomers or macromers.

  Non-silicone hydrogels include, for example, hydrated materials having etafilcon, nelfilcon, ocufilcon, and omafilcon under the US adopted name (USAN). These materials may be A type in USAN, B, C, D type or the like. In some embodiments, it may be a hydrogel contact lens based on a hydrous material comprising 2,3-dihydroxypropyl methacrylate (GMA) alone or in combination with HEMA.

  The non-silicone hydrogel is preferably a material having a high water content, more preferably a material having a water content of 50% or more, and is classified into Group 2 or Group 4 in the US Food and Drug Administration (FDA) soft lens classification. More preferred are materials, such as methafilcon, omafilcon, tetrafilcon, ocufilcon, nelfilcon, nefilcon, femfilcon, polymacon , At least one selected from the group consisting of hilafilcon, nesofilcon, and etafilcon is particularly preferred, methafilcon A, omafilcon A, tetrafilcon A) and Ocufilcon (Ocufilcon) At least one selected from the group consisting of B is most preferred.

Examples of silicone hydrogels include aquafilcon, balafilcon, comfilcon, enfilcon, galyfilcon, lenefilcon, and lenefilcon according to the US adopted name (USAN). ), Lotorafilcon, lotorafilcon, senofilcon, delefilcon, efrofilcon, samfilcon, fanfilcon, stenfilcon, Examples thereof include a water-containing material having somofilcon. These materials may be A type in USAN, B, C, D type or the like. In order to fully expose violet light to the eyeball and to suppress the effect of adjustment lag and peripheral defocus due to the multifocal structure, silicone hydrogel is used in comfilcon, enfilcon, asmo Filcon (asmofilcon), delefilcon (efelefilcon), efrofilcon, samfilcon, fanfilcon, stenfilcon, somofilcon, narafilcon, narafilcon, galyfilcon And at least one selected from the group consisting of senofilcon, comfilcon A, enfilcon A, efrofilcon A, delefilcon A Narafirkon (naraf More preferably, it is at least one selected from the group consisting of ilcon B, galyfilcon A, and senofilcon A.

  When silicone hydrogel is used as a material constituting the multifocal soft contact lens 1 according to this embodiment, from the viewpoint of optical axis stabilization, a low dynamic friction coefficient and a certain softness (in the direction of the optical axis from the lens front surface). Balance with the maximum compression strength). In this case, the appropriate balance is such that the dynamic friction coefficient is 0.1 to 2 and the maximum value of the compressive strength in the optical axis direction from the front surface of the lens is 3 to 5 g. 1.0, and the maximum value of the compressive strength in the optical axis direction from the lens front surface is 3 to 4.5 g, more preferably, the dynamic friction coefficient is 0.1 to 0.7, and The maximum value of compressive strength in the optical axis direction is 3 to 4 g.

  In order to achieve such a balance between a low coefficient of dynamic friction and a certain degree of softness, the material of the multifocal soft contact lens 1 is preferably a silicone hydrogel. Comfilcon, enfilcon, asmofilcon, delefilcon, efrofilcon, samfilcon, fanfilcon, stenfilcon, somofilcon ), Narafilcon, galyfilcon, and senofilcon, preferably at least one selected from the group consisting of comfilcon A, enfilcon A, asmo Asmofilcon A, It is more preferable to use at least one selected from the group consisting of efrofilcon A, delefilcon A, narafilcon B, galyfilcon A, and senofilcon A. .

  In the present embodiment, the material constituting the multifocal soft contact lens 1 preferably has a moisture content of 35 to 70% by mass, and 38 to 60% by mass from the viewpoint of significantly achieving the effects of the present invention. Is more preferable, and it is still more preferable that it is 45-55 mass%. The multifocal soft contact lens 1 according to the present embodiment is formed so as to have an appropriate water content, so that the multifocal soft contact lens 1 appropriately moves in accordance with the movement of the eyeball or the movement of the blink, and the optical axis Can be stable.

  In the present specification, the moisture content indicates the ratio of water in the soft contact lens, and is specifically obtained by the following calculation formula 1.

[Formula 1]
Moisture content (%) = (weight of hydrated water / weight of hydrated soft contact lens) × 100
Such moisture content is measured by a gravimetric method according to the description of ISO18369-4: 2006 and / or medicinal diet No. 0428008 “Revision of contact lens approval standards”.

  In the present embodiment, the material constituting the multifocal soft contact lens 1 preferably has an oxygen transmission coefficient (Dk value) of 115 or more, preferably 120 or more, from the viewpoint of remarkably achieving the effects of the present invention. More preferably, it is more preferably 125 or more. Since the multifocal soft contact lens 1 according to the present embodiment is used for preventing or treating the progression of myopia or posterior eye diseases, it is required to be worn for a long time. The multifocal soft contact lens 1 according to the present embodiment is suitable for long-term wearing by being formed to have a high oxygen transmission coefficient.

In this specification, the unit of measurement of the oxygen permeability coefficient (Dk value) is (cm ² / sec) · (mLO ₂ / (mL · mmHg)). The oxygen permeability coefficient (Dk value) is measured by the electrode method according to the description of ISO18369-4: 2006 and / or Yakushoku No. 0428008 “Revision of contact lens approval standards”.

  When wearing a soft contact lens, high-order aberrations (slight irregular astigmatism) occur not only due to the corneal shape but also due to the contact lens anterior tear film and the movement (centering) of the soft contact lens. May occur. Because of poor water wettability (high static contact angle), the stability of the soft contact lens anterior tear layer is poor, and the soft contact lens anterior tear layer, which should form a uniform layer, is likely to be disturbed. A high-order aberration will be caused over the ring. The multifocal soft contact lens 1 according to the present embodiment is formed to have a low static contact angle, thereby suppressing the occurrence of high-order aberrations.

  In the present embodiment, the material constituting the multifocal soft contact lens 1 has a static contact angle of preferably 1 to 50 °, and preferably 2 to 30 °, from the viewpoint of significantly achieving the effects of the present invention. Is more preferably 3 to 20 °, particularly preferably 4 to 17 °, and most preferably 5 to 15 °.

  In this specification, the static contact angle is measured using a contact angle meter DM-501 (manufactured by Kyowa Interface Science Co., Ltd.) according to the measurement method of the contact angle meter using the droplet method. Specifically, the static contact angle is measured by the following procedure.

  After removing the soft contact lens from the package and draining it, the ISO physiological saline (sodium chloride: 0.83 w / v%, sodium hydrogenphosphate 12 hydrate: 0.5993 w / v%, sodium dihydrogen phosphate) 2 hydrate: 0.0528 w / v%) and store the lenses in 12-well plates dispensed with 5 ml of ISO saline for 1-3 days at room temperature. Wipe away excess moisture from the contact lens, and place the front of the lens upward on the measurement table. Using the attached syringe of the contact angle meter, physiological saline is deposited on the 1 μL lens surface, and the static contact angle of the contact lens is measured.

The measurement conditions for the static contact angle are as follows.
Equipment used: Contact angle meter Drop Master 500 (Kyowa Interface Science)
Drop volume: 1 μl / lens Measurement time: 1 second after landing Contact angle calculation method: θ / 2 method

  The center thickness of the multifocal soft contact lens 1 according to the present embodiment is preferably 0.01 to 0.20 mm, and preferably 0.50 to 1.15 mm, from the viewpoint of significantly achieving the effects of the present invention. Is more preferable. In this specification, the center thickness of the lens means the thickness of the central portion (optical center) of the optical portion 2 of the lens.

  The multifocal soft contact lens 1 according to this embodiment may be a daily wear lens, a long-time wear lens, or a daily disposable lens.

  In another embodiment, a transition region 6 may be provided in the optical part 2 of the multifocal soft contact lens 1 as shown in FIG.

  The transition area 6 is an area in which the first lens power and the second lens power for far vision are smoothly changed. The transition area 6 is arranged outside the central area 3 and inside the peripheral area 4. Although not limited, the transition region 6 may be disposed on the outer periphery of the central region 3 and on the inner periphery of the peripheral region 4.

  The transition region 6 has a predetermined width from the viewpoint that the first lens power and the second lens power do not change abruptly and a good field of view is obtained. The width of the transition region 6 is not limited, but is formed to be 0.2 to 3 mm, and preferably 0.5 to 2 mm.

[Usage]
In the present specification, the “treatment for preventing the progression of myopia or posterior segment disease” refers to suppressing further extension of the axial axis in the myopic eye in which the axial axis is extending. In the multifocal soft contact lens according to the present invention, the central region of the optical part is for far vision, and the focal point is imaged without blur at the central retinal of the patient whose myopia (axial extension) has started to progress, The central area of the optical part is a minus diopter. However, since the eyeball with the eye axis extended has a long rugby ball shape in the front and rear, focusing on the fovea will cause the focus to shift behind the retina in the periphery. Therefore, the multifocal soft contact lens according to the present invention includes a positive addition power in addition to the lens power in the central region of the optical unit in order to shift the focal point forward in the peripheral region of the optical unit. Has a similar optical characteristic to the multifocal soft contact lens for far vision and the peripheral region for near vision.

  This allows the focal point to be imaged on the retina in both the central and peripheral retinas of the myopic eye in which the axial axis is extended (being), and the defocusing of the peripheral part of the retina that promotes the extension of the axial axis is suppressed. It can be used for preventing or treating myopia progression. In addition, the multifocal soft contact lens according to the present invention suppresses the intensity of myopia resulting from excessive extension of the axial axis by suppressing the extension of the axial axis, glaucoma, retinal detachment, retinopathy, macular as complications. It can be used for the prevention or treatment of the progression of posterior ocular diseases such as symptom, choroidal neovascularization, posterior staphyloma or optic neuropathy.

  Since the multifocal soft contact lens according to the present invention is designed to have a high light transmittance in the optical part from a wavelength of 360 nm to 400 nm, the violet light can be sufficiently exposed to the eyeball. For this reason, the multifocal soft contact lens according to the present invention can suppress the extension of the axial axis and can be used for preventing or treating myopia. In addition, the multifocal soft contact lens according to the present invention suppresses the intensity of myopia resulting from excessive extension of the axial axis by suppressing the extension of the axial axis, glaucoma, retinal detachment, retinopathy, macular as complications. It can be used for the prevention or treatment of the progression of posterior ocular diseases such as symptom, choroidal neovascularization, posterior staphyloma or optic neuropathy.

  In addition, “treatment for preventing the progression of myopia or posterior eye disease” includes the ability to see indoors with less sunlight exposure (violet light exposure) and lifestyles with more reading and writing and VDT (Visual Display Terminals) work (sight) And maintaining a high quality QOV (Quality of Vision) even in a lifestyle that promotes myopia in modern society.

  In addition, “treatment for preventing the progression of myopia or posterior ocular disease” occurs in myopia and concomitant symptoms in multifocal soft contact lens package appeal, product appeal, leaflet, instruction manual, conference presentation, etc. Prevention and treatment of complications, “normalization of refraction change or corneal curvature radius change due to axial extension”, “healthy eye growth support”, “growth eye support”, “maintaining visual function It includes describing and referring to words similar to “or“ anti-aging of the eye ”.

  As used herein, “myopia” is axial myopia and refers to myopia caused by axial extension. Axial extension can be detected using an adjustment paralytic agent or a mydriatic agent. That is, myopia mentioned here is caused by a shift in the focus of the naked eye excluding the amount of focus adjustment by the crystalline lens or ciliary body, and temporary eyesight such as accommodative myopia (pseudomyopia). It is different from myopia that returns when fatigue (ciliary muscle fatigue) is removed. Therefore, myopia here refers to “decreased visual function”, “decreased ability to see”, “decreased ability to see far away”, “decreased ability to see far away”, “decreased basic eye performance” , Can also be defined as "original visual loss" or "focus shift".

  “Back-eye disease” refers to diseases in the vitreous, retina, choroid, sclera or optic nerve, specifically glaucoma, retinal detachment, macular hole, foveal sequestration, retinal edema, diabetic retinopathy Retinitis pigmentosa, macular edema, diabetic macular degeneration, myopic macular degeneration, age-related macular degeneration, myopic neuropathy. However, the present embodiment is not limited to these definitions, and can be widely applied to symptoms, diseases, and the like related to eye axis extension.

[Production method]
As the multifocal soft contact lens according to the present invention, a mold having a molding cavity so as to have a desired shape is prepared. A monomer composition of a predetermined water-containing material is accommodated in the molding cavity of this mold, and the monomer composition is polymerized in the mold to obtain a molded product (molding method). Further, mechanical finishing may be performed as necessary (cutting method). As a manufacturing method of the multifocal soft contact lens, various methods conventionally known to those skilled in the art can be adopted, but the molding method is preferable from the viewpoint of production cost.

  The formed water-containing polymer is further immersed in water after forming (hydration treatment). Thereby, it has a predetermined moisture content. Furthermore, the molded water-containing polymer is subjected to sterilization treatment as necessary so that it can be used as a multifocal soft contact lens in a living body.

  The formed water-containing polymer can be surface treated with plasma gas, ultraviolet light, corona discharge, excimer laser, electron beam, etc., 2-hydroxyethyl (meth) acrylate, (meth) acrylic acid, methoxytriethylene as necessary. Surface coating (hydrophilization) with a hydrophilic agent such as glycol (meth) acrylate, dimethylacrylamide, etc. is performed, and properties such as water wettability can be imparted.

  EXAMPLES Next, the present invention will be specifically described with reference to examples, but the present invention is not limited to the following examples.

  The contact lenses used in each test example are as follows.

Example 1
Product name: Biofinity (registered trademark) multi-focal, manufactured by Cooper Vision Japan
(Characteristic)
Soft contact lens classification: Group 1
USAN: comfilcon A
Colorant: Phthalocyanine colorant Water-containing material: Silicone hydrogel Water content: 48%
Static contact angle: 15 °
Oxygen transmission coefficient (Dk value): 128 (cm ² / sec) · (mLO ₂ / (mL · mmHg))
Lens diameter: 14.0 mm
Base curve: 8.6
-3.00 Center thickness at diopter: 0.100 mm
UV absorber: not contained Central region characteristics: for far vision

(Comparative Example 1)
Product Name: One Day Accuview Moist (registered trademark), (manufactured by Johnson & Johnson)
(Characteristic)
Soft contact lens classification: Group 4
USAN: etaficon A
Colorant: Anthraquinone colorant Water-containing material: 2-HEMA (hydroxyethyl methacrylate)
Moisture content: 58%
Static contact angle: 15 °
Oxygen transmission coefficient (Dk value): 28 (cm ² / sec) · (mLO ₂ / (mL · mmHg))
Lens diameter: 14.3 mm
Base curve: 8.4
−3.00 Center thickness at diopter: 0.084 mm
UV absorber: Benzotriazole-based UV absorber Central region characteristics: For near vision

(Comparative Example 2)
Product Name: Medalist Multifocal (registered trademark), (manufactured by Bochrom Japan)
(Characteristic)
Soft contact lens classification: Group 1
USA: polymacon
Colorant: Anthraquinone colorant Water-containing material: 2-HEMA
Moisture content: 38.6%
Static contact angle: 20 °
Oxygen permeability coefficient (Dk value): 9 (cm ² / sec) · (mLO ₂ / (mL · mmHg))
Lens diameter: 14.5mm
Base curve: 8.7
-3.00 Center thickness at diopter: 0.100 mm
UV absorber: not contained Central area characteristics: for near vision

(Comparative Example 3)
Product Name: Medalist (registered trademark) Premier Multi-Focal (manufactured by Bochrom Japan)
(Characteristic)
Soft contact lens classification: Group 3
USAN: balafilcon A
Colorant: Anthraquinone colorant Water-containing material: Silicone hydrogel Water content: 36%
Static contact angle: 73 °
Oxygen permeability coefficient (Dk value): 99 (cm ² / sec) · (mLO ₂ / (mL · mmHg))
Lens diameter: 14.0 mm
Base curve: 8.6
-3.00 center thickness at diopter: 0.090 mm
UV absorber: not contained Central area characteristics: for near vision

(Comparative Example 4)
Product Name: Air Optics (registered trademark) Aqua, (manufactured by Nippon Alcon Co., Ltd.)
(Characteristic)
Soft contact lens classification: Group 1
USAN: lotrafilcon B
Colorant: Phthalocyanine colorant Water-containing material: Silicone hydrogel Water content: 33%
Static contact angle: 18 °
Oxygen transmission coefficient (Dk value): 110 (cm ² / sec) · (mLO ₂ / (mL · mmHg))
Lens diameter: 14.2 mm
Base curve: 8.6
-3.00 center thickness at diopter: 0.070 mm
UV absorber: not contained Central area characteristics: for near vision

(Comparative Example 5)
Product Name: One Day Accuview True Eye (Registered Trademark), (Johnson & Johnson Co., Ltd.)
(Characteristic)
Soft contact lens classification: Group 1
USANarafilcon A
Colorant: Anthraquinone colorant Water-containing material: Silicone hydrogel Water content: 46%
Oxygen transmission coefficient (Dk value): 100 (cm ² / sec) · (mLO ₂ / (mL · mmHg))
Lens diameter: 14.2 mm
Base curve: 9.0
-3.00 center thickness at diopter: 0.085 mm
UV absorber: Benzotriazole-based UV absorber Central region characteristics: For near vision

(Comparative Example 6)
Product Name: Accuview Advance (registered trademark) (made by Johnson & Johnson)
(Characteristic)
Soft contact lens classification: Group 1
USAN: gayfilcon A
Colorant: Benzotriazole-based colorant Water-containing material: Silicone hydrogel Water content: 47%
Static contact angle: 88 °
Oxygen transmission coefficient (Dk value): 60 (cm ² / sec) · (mLO ₂ / (mL · mmHg))
Lens diameter: 14.0 mm
Base curve: 8.7
-3.00 center thickness at diopter: 0.070 mm
UV absorber: Benzotriazole-based UV absorber Central region characteristics: For near vision

[Test Example 1. Dynamic friction coefficient evaluation test]
Each soft contact lens according to Example 1 and Comparative Examples 1 and 3 to 6 was taken out of the package, and after draining, an ISO physiological saline (sodium chloride: 0.83 w / v%, sodium hydrogen phosphate 12 hydrate) 1) in a 12-well plate that was washed twice with 0.5993 w / v%, sodium dihydrogen phosphate dihydrate: 0.0528 w / v%), and further dispensed 5 ml of ISO saline. Stored at room temperature for ~ 3 days. Thereafter, a soft contact lens was bonded to a contact of a friction tester (Tribomaster TL201Ts, manufactured by Trinity Lab). On the other hand, artificial leather was affixed to a moving table of a friction tester, and 15 mL of physiological saline was spread on the artificial leather so that the contactor could be sufficiently distributed over the entire surface. Next, a 50 g weight was attached to the measurement unit. A contact having a soft contact lens adhered thereto was attached to the measurement unit and moved on the artificial leather at a speed of 2.0 mm / second. The measurement was performed 100 times per second for 20 seconds. The dynamic friction coefficient after 10 seconds from the start of movement was measured, and the value obtained by subtracting the dynamic friction coefficient before measurement from the dynamic friction coefficient after 10 seconds was defined as the friction coefficient (μk) of the contact lens. The results are shown in FIG.

  As shown in FIG. 3, Example 1 according to the present invention was confirmed to be a multifocal soft contact lens having a dynamic friction coefficient of less than 0.7 and good slip. Since Example 1 according to the present invention has a low coefficient of kinetic friction, it is unlikely to cause keratoconjunctival damage due to close contact with the keratoconjunctiva, and is expected to move in accordance with the movement or blink of the eyeball and stabilize the optical axis. By stabilizing the optical axis, the effect of the multifocal soft contact lens of the present invention can be sufficiently obtained by sufficiently exposing the violet light to the eyeball and suppressing the adjustment lag and peripheral defocus due to the multifocal structure. It is expected that

[Test Example 2. Compressive strength evaluation test]
Each soft contact lens according to Example 1 and Comparative Examples 1 to 4 and 6 was taken out of the package, and after draining, an ISO physiological saline (sodium chloride: 0.83 w / v%, sodium hydrogen phosphate 12 hydrate) 1) in a 12-well plate that was washed twice with 0.5993 w / v%, sodium dihydrogen phosphate dihydrate: 0.0528 w / v%), and further dispensed 5 ml of ISO saline. Stored at room temperature for ~ 3 days. The contact lens was placed on the bottom of a plastic petri dish filled with physiological saline with the front surface of the spherical lens facing upward. The measurement was started by adjusting the contact lens so that the center of the contact lens was directly below the probe center of the following measuring instrument.
Measuring instrument: Texture analyzer TA. XT. plus TEXTURE ANALYSER

The instrument settings are as follows.
Test mode: Compression measurement Probe type: φ10mm cylinder probe Target Mode: Distance
Distance: 2.5mm
Trigger Type: Auto
Trigger Force: 0.1g
Test Speed: 1.0mm / sec

  After the probe started to push the apex of the contact lens in the optical axis direction from the front surface, the compressive strength when crushing the lens of 2.5 mm (2.5 seconds) was measured, and the maximum value was recorded as the maximum compressive strength value. The results are shown in FIG.

  As shown in FIG. 4, in Example 1 according to the present invention, the maximum value of the compressive strength in the optical axis direction from the front surface of the contact lens was 3 g or more and less than 4 g. If the maximum compression strength from the front of the lens in the direction of the optical axis is too low, the soft contact lens will be displaced due to blinking or eyeball movement, causing the optical axis to become unstable, and if the maximum value is too high, the soft contact lens Since adhesion to the keratoconjunctiva can cause damage to the keratoconjunctiva, it was confirmed that Example 1 according to the present invention has moderate softness. By stabilizing the optical axis, the effect of the multifocal soft contact lens of the present invention can be sufficiently obtained by sufficiently exposing the violet light to the eyeball and suppressing the adjustment lag and peripheral defocus due to the multifocal structure. It is expected that

[Test Example 3. Light transmittance evaluation test]
After each soft contact lens according to Example 1 and Comparative Examples 1 to 4 was taken out of the package and drained, the ISO physiological saline (sodium chloride: 0.83 w / v%, sodium hydrogenphosphate dodecahydrate: 0.5993 w / v%, sodium dihydrogen phosphate dihydrate: 0.0528 w / v%), and the lens was placed in a 12-well plate dispensed with 5 ml of ISO physiological saline. Stored at room temperature for days. Excess moisture of the contact lens was wiped, the cell was held in a contact lens holder, and measurement was performed using a TM-1 spectral transmittance meter manufactured by TOPCON. Next, the transmittance at intervals of 5 nm is output to the PC, and the average value of each transmittance is calculated as the light transmittance ranging from 360 nm to 400 nm, and the exposure amount of violet light that is known to bring about the progression prevention of myopia It was used as an index. The comparison result between Example 1 and Comparative Example 1 is shown in FIG.

  As shown in FIG. 5, it was confirmed that Example 1 according to the present invention has a light transmittance of 90% or more over a wavelength range of 360 nm to 400 nm in the optical part. Since Example 1 according to the present invention can sufficiently expose the eyeball to violet light, which is known to cause the progression prevention of myopia, it suppresses the extension of the axial axis, and prevents or treats the progression of myopia. Expected to have an effect.

[Test Example 4. Evaluation test of near-side adjustment tremor]
When the load on the ciliary body is large, mechanical tension in the direction perpendicular to the optical axis of the eyeball is generated, which leads to extension of the axial length and contributes to the progression of myopia. It is explained by. The tension state of the ciliary muscle due to a long gaze operation or the like can be measured by using an appearance frequency (HFC: High Frequency Component) value of the adjustment fine tremor high frequency component as an index. The HFC value is a value indicating the frequency of appearance of a high frequency component when a fixed distance is observed with respect to the fine adjustment that occurs when the refractive value of the eye is recorded over time. The high frequency component indicates the vibration of the crystalline lens, that is, the tremor of the ciliary muscle. The higher the frequency of appearance of the high frequency component, the stronger the stress is generated in the ciliary muscle. The body muscles are tense and the eyes are tired.

Evaluation was performed with five eyes by three subjects. Each subject is a person engaged in VDT work for 4 hours or more per day, complaining of subjective symptoms, and having confirmed eye fatigue by a doctor (age 30 to 40 years).
A contact lens tailored to the subject's visual acuity and base curve was worn on the morning of the measurement day. As a control, a single-focus contact lens having no addition power (Comparative Example 7) is worn, and a multifocal contact lens (Example 1) having an addition power (+1.0 D) is worn on another day, and the value of each adjustment fine movement. Compared. In the morning, normal VDT work (character input work while looking at a personal computer screen) was performed for 2 hours to accumulate eye strain. Thereafter, the HFC value was measured according to the attached instruction manual using the following apparatus and conditions.
Device name: Eye adjustment function measurement software AA-1 (made by Nidec Corporation)
For the control fine movement average value in the control eye wearing a single focus contact lens having no addition power, the suppression rate of the adjustment fine movement average value when the contact lens having the same power and addition power +1.0 was worn was calculated.

[Formula 2]
Inhibition rate in near-field accommodation fine movement = (average adjustment fine movement in control eyes without addition-addition power + 1.0 adjustment fine movement average value) / adjustment fine movement average in control eyes without addition x 100

Comparative Example 7 has the same contact lens characteristics as Example 1, but the following was used instead of multifocal and single focal.
(Comparative Example 7)
Product name: Biofinity (registered trademark), Cooper Vision Japan Co., Ltd.
(Characteristic)
Soft contact lens classification: Group 1
USAN: comfilcon A
Colorant: Phthalocyanine colorant Water-containing material: Silicone hydrogel Water content: 48%
Static contact angle: 15 °
Oxygen transmission coefficient (Dk value): 128 (cm ² / sec) · (mLO ₂ / (mL · mmHg))
Lens diameter: 14.0 mm
Base curve: 8.6
-3.00 Center thickness at diopter: 0.100 mm
UV absorber: not contained Central region characteristics: for far vision

  The result is shown in FIG. In FIG. 6, the vertical axis represents the suppression rate (%) in near-field accommodation fine movement calculated by the above-described formula 2, and the horizontal axis represents the central power of the contact lens of the subject eye.

  As shown in FIG. 6, in all measurements, it was recognized that the adjustment fine movement can be suppressed by 7.5% to 17.2% by wearing a contact lens having an addition power of +1.0. By wearing the multifocal soft contact lens according to the present invention, it is possible to reduce the adjustment load of the ciliary body, thereby suppressing the occurrence of mechanical tension in the direction perpendicular to the optical axis of the eyeball. It is possible to suppress the extension of the axial length, which is a cause of myopia progression.

  DESCRIPTION OF SYMBOLS 1 ... Multifocal contact lens, 2 ... Optical part, 3 ... Center area | region, 4 ... Peripheral area | region, 5 ... Edge part, 6 ... Transition area | region

Claims (6)

A multifocal soft contact lens used for preventing or treating myopia or posterior eye disease progression,
A central region having a first lens power for distance vision;
An optical unit having a second lens power and a peripheral region disposed outside the central region;
The multifocal soft contact lens whose light transmittance from wavelength 360nm to 400nm in this optical part is 70%-100%.   The multifocal soft contact lens according to claim 1, wherein a dynamic friction coefficient of the lens is 0.1 to 2.4.   The multifocal soft contact lens according to claim 1 or 2, wherein a maximum value of compressive strength in the optical axis direction from the lens front surface is 3 to 5 g.   The multifocal soft contact lens according to any one of claims 1 to 3, wherein a material of the lens is a silicone hydrogel or a non-silicone hydrogel. The silicone hydrogel is composed of a comfilcon, an enfilcon, an asmofilcon, a delefilcon, an efrofilcon, a samfilcon, a fanfilcon, a stainless filcon. 5. The multifocal soft contact lens according to claim 4, which is at least one selected from the group consisting of (stenfilcon), somofilcon, narafilcon, galyfilcon, and senofilcon. .   The non-silicone hydrogel comprises metafilcon, omafilcon, tetrafilcon, ocufilcon, nelfilcon, nefilcon, femfilcon, polymercon ( The multifocal soft contact lens according to claim 4, which is at least one selected from the group consisting of polymacon, hilafilcon, nesofilcon, and etafilcon.

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