Ophthalmologic composition for soft contact lenses

Abstract

To provide an ophthalmologic composition that suppresses a change in the diameter of a soft contact lens while containing at least one selected from the group consisting of cromoglycate and salts thereof.SOLUTION: An ophthalmologic composition for soft contact lenses contains (A) at least one selected from the group consisting of cromoglycate and salts thereof and (B) at least one selected from the group consisting of chlorpheniramine and salts thereof, inorganic antioxidants, and water-soluble polymer compounds.SELECTED DRAWING: None

Description

[Technical field]

[0001] The present invention relates to an ophthalmic composition for soft contact lenses. [Background technology]

[0002] Sodium cromoglycate is sometimes incorporated into ophthalmic compositions for the purpose of exerting an antiallergic effect (for example, Patent Document 1). [Prior art documents] [Patent documents]

[0003] [Patent Document 1] JP 2005-187407 A Summary of the Invention [Problem to be solved by the invention]

[0004] However, when soft contact lenses come into contact with an ophthalmic composition, their shape and physical properties may change depending on the composition of the ophthalmic composition. If an ophthalmic composition that causes a large change in the diameter of the soft contact lens is used, there is a problem that discomfort such as a rough or stiff feeling and poor wearing comfort may occur when wearing and / or mounting the soft contact lenses.

[0005] The present invention has been made in consideration of the above circumstances, and aims to provide an ophthalmic composition that contains at least one selected from the group consisting of cromoglycic acid and its salts and is capable of suppressing changes in the diameter of a soft contact lens. [Means for solving the problem]

[0006] The present inventors have unexpectedly found that by blending at least one selected from the group consisting of chlorpheniramine and its salts, water-soluble antioxidants, and water-soluble polymer compounds with an ophthalmic composition containing at least one selected from the group consisting of cromoglycic acid and its salts, the change in diameter of a soft contact lens can be suppressed. The present invention is based on these findings and provides the following inventions.

[0007] [1] An ophthalmic composition for soft contact lenses comprising (A) at least one member selected from the group consisting of cromoglycic acid and its salts, and (B) at least one member selected from the group consisting of chlorpheniramine and its salts, inorganic antioxidants, and water-soluble polymer compounds. [2] The ophthalmic composition for soft contact lenses according to [1], wherein the content of component (A) is 1 to 2 w / v % based on the total amount of the ophthalmic composition. [3] The ophthalmic composition for soft contact lenses according to [1] or [2], wherein the inorganic antioxidant is at least one selected from the group consisting of sulfurous acid and its salts, pyrosulfite and its salts, hydrogen sulfite and its salts, thiosulfuric acid and its salts, and alkali metal iodides. [4] The ophthalmic composition for soft contact lenses according to any one of [1] to [3], wherein the water-soluble polymer compound is at least one selected from the group consisting of vinyl polymer compounds, cellulose polymer compounds, and mucopolysaccharides. [5] The ophthalmic composition for soft contact lenses according to any one of [1] to [4], further comprising a chelating agent. [6] The ophthalmic composition for soft contact lenses according to any one of [1] to [5], further comprising a buffering agent. [7] The ophthalmic composition for soft contact lenses according to any one of [1] to [6], which has a pH of 5 to 9. [8] The ophthalmic composition for soft contact lenses according to any one of [1] to [7], which has an osmotic pressure ratio of 0.5 to 2. [9] 9. An ophthalmic composition for soft contact lenses according to any one of [1] to [8], wherein when the soft contact lens is immersed in the composition, the change in diameter of the lens is 0.2 mm or less.

[11] The ophthalmic composition for soft contact lenses according to any one of [1] to [9], which is a nonionic ophthalmic composition for soft contact lenses.

[12] An ophthalmic composition for soft contact lenses according to any of [1] to [9], which is classified as Group 2 in the Notification of the Director of the Pharmaceutical Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 0330-6 and the Notification of the Director of the Medical Device Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 0330-4, entitled "Handling of documents to be attached when applying for approval to manufacture (import) soft contact lenses and soft contact lens disinfectants" (March 30, 2021).

[13] An ophthalmic composition for soft contact lenses according to any of [1] to [9], which is an ophthalmic composition for silicone hydrogel contact lenses classified as Group 2 in the Notification of the Director of the Pharmaceutical Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 0330-6 and the Notification of the Director of the Medical Device Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 0330-4, "Regarding the handling of documents to be attached when applying for approval to manufacture (import) soft contact lenses and soft contact lens disinfectants" (March 30, 2021).

[14] The ophthalmic composition for soft contact lenses according to any one of [1] to

[13] , wherein the total content of dibutylhydroxyanisole and dibutylhydroxytoluene is less than 0.005 w / v % based on the total amount of the ophthalmic composition.

[15] The ophthalmic composition for soft contact lenses according to any one of [1] to

[14] , which does not contain benzalkonium or a salt thereof.

[16] The ophthalmic composition for soft contact lenses according to any one of [1] to

[15] , which does not contain sorbic acid or a salt thereof.

[17] The ophthalmic composition for soft contact lenses according to any one of [1] to

[16] , which does not contain at least one selected from the group consisting of chlorhexidine, alexidine, polyhexamethylene biguanide, polyaminopropyl biguanide, and salts thereof.

[18] The ophthalmic composition for soft contact lenses according to any one of [1] to

[17] , which does not contain a calcium salt and / or a zinc salt.

[19] The ophthalmic composition for soft contact lenses according to any one of [1] to

[18] , which does not contain pranoprofen.

[20] The ophthalmic composition for soft contact lenses according to any one of [1] to

[19] , which does not contain tetrahydrozoline or a salt thereof. [twenty one] A method for suppressing change in diameter of a soft contact lens when the soft contact lens is immersed in an ophthalmic composition for soft contact lenses, the method comprising the steps of: (A) an ophthalmic composition for soft contact lenses containing at least one member selected from the group consisting of cromoglycic acid and its salts; and (B) at least one member selected from the group consisting of chlorpheniramine and its salts, water-soluble antioxidants, and water-soluble polymer compounds. [twenty two] (B) an ophthalmic composition containing at least one selected from the group consisting of chlorpheniramine and its salts, inorganic antioxidants, and water-soluble polymer compounds, which suppresses change in diameter of a soft contact lens when immersed in a composition containing (A) at least one selected from the group consisting of cromoglycic acid and its salts. Effect of the Invention

[0008] According to the present invention, an ophthalmic composition capable of suppressing changes in diameter of a soft contact lens can be provided. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] Hereinafter, an embodiment of the present invention will be described in detail. However, the present invention is not limited to the following embodiment.

[0010] In this specification, unless otherwise specified, the unit of content "%" means "w / v%" and is synonymous with "g / 100 mL".

[0011] The ophthalmic composition for soft contact lenses according to this embodiment (hereinafter also referred to as "the ophthalmic composition according to this embodiment") contains (A) at least one selected from the group consisting of cromoglycic acid and its salts (also referred to simply as "component (A)") and (B) at least one selected from the group consisting of chlorpheniramine and its salts, inorganic antioxidants, and water-soluble polymer compounds (also referred to simply as "component (B)").

[0012] [Component (A)] Cromolyn and its salts are not particularly limited, so long as they are medicamentously, pharmacologically (pharmaceutical) or physiologically acceptable.

[0013] Examples of the salt of cromoglycic acid include alkali metal salts such as sodium salt, potassium salt, etc. As cromoglycic acid and its salts, from the viewpoint of further enhancing the effect of the present invention, alkali metal salts of cromoglycic acid are preferred, and sodium cromoglycate is more preferred.

[0014] Cromolyn and its salts may be commercially available. Cromolyn and its salts may be used alone or in combination of two or more.

[0015] The content of cromoglycic acid and its salts in the ophthalmic composition according to this embodiment is not particularly limited, and is appropriately set depending on the type of cromoglycic acid and its salts, the type and content of other blended components, the use and formulation form of the ophthalmic composition, etc. From the viewpoint of more significantly exhibiting the effects of the present invention, the content of cromoglycic acid and its salts is, for example, preferably 0.1 to 4 w / v%, more preferably 0.5 to 3 w / v%, even more preferably 0.8 to 2.5 w / v%, and particularly preferably 1 to 2 w / v%, based on the total amount of the ophthalmic composition according to this embodiment.

[0016] [Component (B): Chlorpheniramine and its salts] There are no particular limitations on chlorpheniramine and its salts, so long as they are medicamentally, pharmacologically (pharmaceutical) or physiologically acceptable.

[0017] Examples of salts of chlorpheniramine include chlorpheniramine maleate, etc. As chlorpheniramine and its salts, chlorpheniramine maleate is preferred from the viewpoint of further enhancing the effect of the present invention.

[0018] Chlorpheniramine and its salts may be commercially available. Chlorpheniramine and its salts may be used alone or in combination of two or more.

[0019] When component (B) contains chlorpheniramine and its salt, the content of chlorpheniramine and its salt in the ophthalmic composition according to the present embodiment is not particularly limited and is appropriately set depending on the type of chlorpheniramine and its salt, the type and content of other blended components, the formulation form of the ophthalmic composition, etc. From the viewpoint of more significantly exhibiting the effects of the present invention, the content of chlorpheniramine and its salt is, for example, preferably 0.001 to 0.1 w / v%, more preferably 0.003 to 0.08 w / v%, further preferably 0.005 to 0.05 w / v%, and particularly preferably 0.015 to 0.03 w / v%, based on the total amount of the ophthalmic composition.

[0020] When the (B) component contains chlorpheniramine and its salt, the content ratio of chlorpheniramine and its salt to the (A) component in the ophthalmic composition according to the present embodiment is not particularly limited, but from the viewpoint of more significantly exhibiting the effects of the present invention, for example, the total content of chlorpheniramine and its salt is preferably 0.0005 to 0.1 parts by mass, more preferably 0.0015 to 0.08 parts by mass, even more preferably 0.0025 to 0.05 parts by mass, and particularly preferably 0.0075 to 0.03 parts by mass, per part by mass of the total content of the (A) component contained in the ophthalmic composition. In addition, the total content of chlorpheniramine and its salt may be 0.015 parts by mass or 0.03 parts by mass per part by mass of the total content of the (A) component.

[0021] [Component (B): inorganic antioxidant] Examples of inorganic antioxidants include sulfurous acid and its salts, pyrosulfurous acid and its salts, hydrogen sulfite and its salts, thiosulfuric acid and its salts, and alkali metal iodides. There are no particular limitations on the inorganic antioxidants, so long as they are medicamentally, pharmacologically (pharmaceutical) or physiologically acceptable.

[0022] Examples of sulfurous acid and its salts include alkali metal salts such as sodium salts and potassium salts. From the viewpoint of further enhancing the effects of the present invention, sulfurous acid and its salts are preferably alkali metal salts of sulfurous acid, and more preferably sodium sulfite.

[0023] Examples of pyrosulfurous acid and its salts include alkali metal salts such as sodium salts and potassium salts. From the viewpoint of further enhancing the effects of the present invention, pyrosulfurous acid and its salts are preferably alkali metal salts of pyrosulfurous acid, and more preferably sodium pyrosulfite.

[0024] Examples of hydrogen sulfite and its salts include alkali metal salts such as sodium salts and potassium salts. From the viewpoint of further enhancing the effects of the present invention, hydrogen sulfite and its salts are preferably alkali metal salts of hydrogen sulfite, and more preferably sodium hydrogen sulfite.

[0025] Examples of thiosulfuric acid and salts thereof include alkali metal salts such as sodium salts and potassium salts. From the viewpoint of further enhancing the effects of the present invention, thiosulfuric acid and salts thereof are preferably alkali metal salts of thiosulfuric acid, and more preferably sodium thiosulfate.

[0026] Examples of the alkali metal iodide salt include sodium iodide and potassium iodide. As thiosulfuric acid and its salts, potassium iodide is preferred from the viewpoint of further enhancing the effects of the present invention.

[0027] When component (B) contains an inorganic antioxidant, the content of the inorganic antioxidant in the ophthalmic composition according to this embodiment is not particularly limited and is appropriately set depending on the type of inorganic antioxidant, the type and content of other blended components, the formulation form of the ophthalmic composition, etc. From the viewpoint of more significantly exhibiting the effects of the present invention, the content of the inorganic antioxidant is, for example, preferably 0.0005 to 3 w / v%, more preferably 0.001 to 2 w / v%, even more preferably 0.003 to 1 w / v%, and particularly preferably 0.005 to 0.5 w / v%, based on the total amount of the ophthalmic composition.

[0028] When component (B) contains an inorganic antioxidant, the content ratio of the inorganic antioxidant relative to component (A) in the ophthalmic composition of this embodiment is not particularly limited; however, from the viewpoint of more significantly achieving the effects of the present invention, for example, the total content of the inorganic antioxidant relative to 1 part by mass of the total content of component (A) contained in the ophthalmic composition is preferably 0.00025 to 3 parts by mass, more preferably 0.0005 to 2 parts by mass, even more preferably 0.0015 to 1 part by mass, and particularly preferably 0.0025 to 0.5 parts by mass.

[0029] [Component (B): Water-soluble polymer compound] Examples of the water-soluble polymeric compound include vinyl polymeric compounds, cellulose polymeric compounds, and mucopolysaccharides.

[0030] Examples of the vinyl polymer compound include polyvinylpyrrolidone, polyvinyl alcohol, carboxyvinyl polymer, etc. As the vinyl polymer compound, polyvinylpyrrolidone is preferable from the viewpoint of further enhancing the effect of the present invention.

[0031] The K value of polyvinylpyrrolidone is not particularly limited, but from the viewpoint of achieving the effects of the present invention remarkably, it is preferably 10 to 200, more preferably 30 to 150, and even more preferably 60 to 120. Among them, polyvinylpyrrolidone K25, polyvinylpyrrolidone K30, polyvinylpyrrolidone K60, and polyvinylpyrrolidone K90 are preferable, polyvinylpyrrolidone K25, polyvinylpyrrolidone K30, and polyvinylpyrrolidone K90 are more preferable, and polyvinylpyrrolidone K90 is even more preferable. The K value (viscosity characteristic value) of polyvinylpyrrolidone is calculated according to the method described in the 17th revised Japanese Pharmacopoeia "Povidone". Since the K value is 90 to 108% of the indicated K value, for example, "K90" refers to a K value (viscosity characteristic value) in the range of 81.0 to 97.2.

[0032] Examples of cellulose-based polymer compounds include methyl cellulose, ethyl cellulose, hydroxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose (hypromellose), carboxymethyl cellulose, carboxyethyl cellulose, and salts thereof. Examples of such salts include salts with organic bases (amine salts, basic ammonium salts such as arginine, etc.), salts with inorganic bases (alkali metal salts such as ammonium salts, sodium salts, potassium salts, etc., alkaline earth metal salts such as calcium salts, magnesium salts, aluminum salts, etc.), and the like. Among these, sodium salts, potassium salts, and calcium salts are more preferred, and sodium salts are particularly preferred. As cellulose-based polymer compounds, from the viewpoint of further enhancing the effects of the present invention, hydroxypropyl methyl cellulose (hypromellose), hydroxyethyl cellulose, and sodium carboxymethyl cellulose are preferred, and hydroxypropyl methyl cellulose (hypromellose) is more preferred.

[0033] Examples of mucopolysaccharides include chondroitin sulfate and its salts, hyaluronic acid and its salts, etc. Examples of the salts of hyaluronic acid and chondroitin sulfate include salts with organic bases (amine salts, basic ammonium salts such as arginine, etc.), salts with inorganic bases (alkali metal salts such as ammonium salts, sodium salts, potassium salts, etc., alkaline earth metal salts such as calcium salts, magnesium salts, aluminum salts, etc.), etc., among which sodium salts, potassium salts, and calcium salts are more preferred, and sodium salts are particularly preferred.As mucopolysaccharides, from the viewpoint of further enhancing the effect of the present invention, chondroitin sulfate and its salts, hyaluronic acid and its salts are preferred, and chondroitin sulfate and its salts are more preferred.

[0034] The weight-average molecular weight of chondroitin sulfate or a salt thereof is not particularly limited, but from the viewpoint of achieving the effects of the present invention remarkably, it is preferably 1,000 to 100,000, more preferably 5,000 to 90,000, even more preferably 10,000 to 80,000, particularly preferably 20,000 to 70,000, and most preferably 20,000 to 40,000. The weight-average molecular weight of chondroitin sulfate or a salt thereof can be determined by using gel permeation chromatography in which a multi-angle light scattering detector (MALS detector) and a differential refractive index detector (RI detector) are connected online. Specifically, the following conditions are presented. <Standard sample preparation> 5 mg of chondroitin sulfate or its salt is added to 10 mL of 0.1 M sodium nitrate aqueous solution and stirred gently at room temperature until completely dissolved. <Conditions for measuring weight average molecular weight> Equipment: Gel permeation chromatograph - Multi-angle light scattering meter Detector: Differential refractive index detector (Wyatt Technology Optilab rEX) Multi-angle light scattering detector (DAWN HELEOS, Wyatt Technology) Column: Shodex OHpak SB-806M HQ x 2 (φ7.8mm x 30cm, Showa Denko) Solvent: 0.1M sodium nitrate solution Flow rate: 0.7mL / min Column temperature: 23℃ Detector temperature: 23℃ Injection volume: 0.2mL Data processing: Wyatt Technology data processing system (ASTRA)

[0035] When the (B) component contains a water-soluble polymer compound, the content of the water-soluble polymer compound in the ophthalmic composition according to this embodiment is not particularly limited and is appropriately set depending on the type of water-soluble polymer compound, the type and content of other blended components, the use and formulation form of the ophthalmic composition, etc. From the viewpoint of more significantly exhibiting the effects of the present invention, the content of the water-soluble polymer compound is, for example, preferably 0.00001 to 10 w / v%, more preferably 0.0001 to 8 w / v%, even more preferably 0.0005 to 5 w / v%, and particularly preferably 0.001 to 3 w / v%, based on the total amount of the ophthalmic composition according to this embodiment.

[0036] When the water-soluble polymer compound is polyvinylpyrrolidone, from the viewpoint of more prominently exhibiting the effects of the present invention, the content thereof is, for example, based on the total amount of the ophthalmic composition according to this embodiment, preferably 0.0001 to 10 w / v%, more preferably 0.0005 to 8 w / v%, even more preferably 0.001 to 5 w / v%, even more preferably 0.005 to 3 w / v%, particularly preferably 0.01 to 3 w / v%, and most preferably 0.01 to 1 w / v%.

[0037] When the water-soluble polymer compound is hydroxypropyl methylcellulose (hypromellose), from the viewpoint of more prominently exhibiting the effects of the present invention, the content thereof is, for example, based on the total amount of the ophthalmic composition of this embodiment, preferably 0.0001 to 10 w / v%, more preferably 0.0005 to 8 w / v%, even more preferably 0.001 to 5 w / v%, even more preferably 0.005 to 3 w / v%, particularly preferably 0.01 to 1 w / v%, and most preferably 0.01 to 0.5 w / v%.

[0038] When the water-soluble polymer compound is hydroxyethyl cellulose, from the viewpoint of more prominently exhibiting the effects of the present invention, the content thereof is, for example, based on the total amount of the ophthalmic composition according to this embodiment, preferably the total content of hydroxyethyl cellulose is 0.0001 to 10 w / v%, more preferably 0.0005 to 8 w / v%, even more preferably 0.001 to 5 w / v%, even more preferably 0.005 to 3 w / v%, particularly preferably 0.01 to 1 w / v%, and most preferably 0.01 to 0.5 w / v%, in terms of the total amount of the ophthalmic composition according to this embodiment.

[0039] When the water-soluble polymer compound is methylcellulose, from the viewpoint of more prominently exhibiting the effects of the present invention, for example, based on the total amount of the agent according to this embodiment, the total content of methylcellulose is preferably 0.0001 to 10 w / v%, more preferably 0.0005 to 8 w / v%, even more preferably 0.001 to 5 w / v%, even more preferably 0.005 to 3 w / v%, particularly preferably 0.01 to 1 w / v%, and most preferably 0.01 to 0.5 w / v%.

[0040] When the water-soluble polymer compound is carboxymethylcellulose and its salt, from the viewpoint of more significantly exhibiting the effects of the present invention, for example, based on the total amount of the ophthalmic composition according to the present embodiment, the total content of carboxymethylcellulose is preferably 0.0001 to 10 w / v%, more preferably 0.0005 to 8 w / v%, even more preferably 0.001 to 5 w / v%, even more preferably 0.005 to 3 w / v%, particularly preferably 0.005 to 1 w / v%, and most preferably 0.005 to 0.5 w / v%. Furthermore, as carboxymethylcellulose and its salt, sodium carboxymethylcellulose is preferred.

[0041] When the water-soluble polymer compound is chondroitin sulfate and its salts, from the viewpoint of more significantly achieving the effects of the present invention, the content thereof is, for example, based on the total amount of the ophthalmic composition of this embodiment, preferably 0.00001 to 5 w / v%, more preferably 0.0001 to 3 w / v%, even more preferably 0.0005 to 2 w / v%, even more preferably 0.001 to 1 w / v%, and particularly preferably 0.005 to 0.5 w / v%.

[0042] When the water-soluble polymer compound is hyaluronic acid and its salts, from the viewpoint of more prominently exhibiting the effects of the present invention, the content thereof is, for example, based on the total amount of the ophthalmic composition according to this embodiment, preferably 0.00001 to 1 w / v%, more preferably 0.0001 to 0.5 w / v%, even more preferably 0.0005 to 0.3 w / v%, even more preferably 0.001 to 0.1 w / v%, and particularly preferably 0.001 to 0.05 w / v%, in terms of the total content of hyaluronic acid and its salts.

[0043] When the (B) component contains a water-soluble polymer compound, the content ratio of the water-soluble polymer compound relative to the (A) component in the ophthalmic composition of this embodiment is not particularly limited. However, from the viewpoint of more significantly achieving the effects of the present invention, for example, the total content of the water-soluble polymer compound per 1 part by mass of the total content of the (A) component contained in the ophthalmic composition is preferably 0.000005 to 10 parts by mass, more preferably 0.00005 to 8 parts by mass, even more preferably 0.00025 to 5 parts by mass, and particularly preferably 0.0005 to 3 parts by mass.

[0044] [Chelating Agent] The ophthalmic composition according to the present embodiment preferably further contains a chelating agent. When the ophthalmic composition according to the present embodiment further contains a chelating agent, the effect of the present invention is more pronounced. The chelating agent is not particularly limited as long as it is medicamentarily, pharmacologically (pharmaceutical) or physiologically acceptable.

[0045] Examples of chelating agents include ethylenediaminetetraacetic acid (edetic acid) (EDTA), ethylenediaminetriacetic acid, ethylenediaminediacetic acid (EDDA), N-(2-hydroxyethyl)ethylenediaminetriacetic acid (HEDTA), diethylenetriaminepentaacetic acid (DTPA), citric acid, gluconic acid, and salts thereof, etc. Examples of these salts include metal salts such as sodium salts, potassium salts, calcium salts, and magnesium salts.

[0046] As the chelating agent, from the viewpoint of further enhancing the effects of the present invention, edetic acid or a salt thereof is preferred, sodium salt of edetic acid is more preferred, disodium edetate (sodium edetate in the Japanese Pharmacopoeia) and tetrasodium edetate are further preferred, and disodium edetate is particularly preferred. In another embodiment, as the chelating agent, from the viewpoint of further enhancing the effects of the present invention, citric acid or a salt thereof is preferred, and citric acid is more preferred.

[0047] The chelating agent may be a commercially available one. The chelating agent may be used alone or in combination of two or more kinds.

[0048] The content of the chelating agent in the ophthalmic composition according to the present embodiment is not particularly limited, and is appropriately set depending on the type of chelating agent, the type and content of other blended components, the application and formulation form of the ophthalmic composition, etc. From the viewpoint of more significantly exhibiting the effects of the present invention, the content of the chelating agent is, for example, preferably 0.001 to 3 w / v%, more preferably 0.005 to 2 w / v%, even more preferably 0.008 to 1 w / v%, and particularly preferably 0.01 to 0.5 w / v%, based on the total amount of the ophthalmic composition according to the present embodiment.

[0049] When the ophthalmic composition according to this embodiment contains a chelating agent, the content ratio of the chelating agent and a salt thereof relative to the component (A) in the ophthalmic composition according to this embodiment is not particularly limited. From the viewpoint of more significantly exhibiting the effects of the present invention, for example, the total content of the chelating agent relative to 1 part by mass of the total content of the component (A) contained in the ophthalmic composition is preferably 0.001 to 3 parts by mass, more preferably 0.005 to 2 parts by mass, even more preferably 0.008 to 1 part by mass, and particularly preferably 0.01 to 0.5 parts by mass.

[0050] [Buffer] The ophthalmic composition according to the present embodiment preferably further contains a buffering agent. When the ophthalmic composition according to the present embodiment further contains a buffering agent, the effect of the present invention is more pronounced. The buffering agent is not particularly limited as long as it is medicamentarily, pharmacologically (pharmaceutical) or physiologically acceptable.

[0051] Examples of the buffer include inorganic buffers derived from inorganic acids, and organic buffers derived from organic acids or organic bases.

[0052] Examples of inorganic buffers include boric acid buffers, phosphate buffers, and carbonate buffers. Examples of boric acid buffers include boric acid or its salts (alkali metal borates, alkaline earth metal borates, etc.). Examples of phosphate buffers include phosphoric acid or its salts (alkali metal phosphates, alkaline earth metal phosphates, etc.). Examples of carbonate buffers include carbonic acid or its salts (alkali metal carbonates, alkaline earth metal carbonates, etc.). In addition, hydrates of borates, phosphates, or carbonates may be used as boric acid buffers, phosphate buffers, or carbonate buffers. More specific examples include borate buffers such as boric acid or salts thereof (sodium borate, potassium tetraborate, potassium metaborate, ammonium borate, borax, etc.); phosphate buffers such as phosphoric acid or salts thereof (disodium hydrogen phosphate, sodium dihydrogen phosphate, potassium dihydrogen phosphate, trisodium phosphate, tripotassium phosphate, calcium monohydrogen phosphate, calcium dihydrogen phosphate, etc.); and carbonate buffers such as carbonic acid or salts thereof (sodium bicarbonate, sodium carbonate, ammonium carbonate, potassium carbonate, calcium carbonate, potassium bicarbonate, magnesium carbonate, etc.).

[0053] Examples of organic buffers include citrate buffers, acetate buffers, lactate buffers, succinate buffers, tris buffers, and AMPD buffers. Examples of citrate buffers include citric acid or its salts (alkali metal citrate, alkaline earth metal citrate, etc.). Examples of acetate buffers include acetic acid or its salts (alkali metal acetate, alkaline earth metal acetate, etc.). Examples of lactate buffers include lactic acid or its salts (alkali metal lactate, alkaline earth metal lactate, etc.). Examples of succinate buffers include succinic acid or its salts (alkali metal succinate, etc.). In addition, hydrates of citrate, acetate, lactate, or succinate may be used as citrate buffers, acetate buffers, lactate buffers, or succinate buffers. More specific examples of the citrate buffer include citric acid or its salts (sodium citrate, potassium citrate, calcium citrate, sodium dihydrogen citrate, disodium citrate, etc.); acetic acid buffer includes acetic acid or its salts (ammonium acetate, sodium acetate, potassium acetate, calcium acetate, etc.); lactic acid buffer includes lactic acid or its salts (sodium lactate, potassium lactate, calcium lactate, etc.); succinic acid buffer includes succinic acid or its salts (monosodium succinate, disodium succinate, etc.). Examples of the tris buffer include trometamol or its salts (trometamol hydrochloride, etc.). Examples of the AMPD buffer include 2-amino-2-methyl-1,3-propanediol or its salts.

[0054] As the buffer, from the viewpoint of further enhancing the effect of the present invention, an inorganic buffer is preferable, a borate buffer (e.g., a combination of boric acid and borax, etc.) or a phosphate buffer (e.g., a combination of disodium hydrogen phosphate (sodium hydrogen phosphate hydrate in the Japanese Pharmacopoeia) and sodium dihydrogen phosphate, etc.) is more preferable, and a combination of boric acid and borax is even more preferable.

[0055] The buffering agent may be a commercially available one. The buffering agent may be used alone or in combination of two or more kinds.

[0056] The content of the buffering agent in the ophthalmic composition according to the present embodiment is not particularly limited, and is appropriately set depending on the type of the buffering agent, the type and content of other blended components, the use of the ophthalmic composition, the formulation form, etc. From the viewpoint of more significantly exhibiting the effects of the present invention, the content of the buffering agent is, for example, preferably 0.01 to 10 w / v%, more preferably 0.05 to 8 w / v%, further preferably 0.08 to 5 w / v%, and particularly preferably 0.1 to 3 w / v%, based on the total amount of the ophthalmic composition according to the present embodiment.

[0057] [Inorganic salts] The ophthalmic composition according to the present embodiment preferably further contains an inorganic salt. When the ophthalmic composition according to the present embodiment further contains an inorganic salt, the effect of the present invention is more pronounced. In this specification, "inorganic salts" does not include (B) inorganic antioxidants. There are no particular limitations on the inorganic salts, so long as they are medicamentally, pharmacologically (pharmaceutical) or physiologically acceptable.

[0058] Examples of inorganic salts include metal chlorides such as calcium chloride, magnesium chloride, sodium chloride, and potassium chloride; metal sulfates such as calcium sulfate, magnesium sulfate, sodium sulfate, and potassium sulfate; and ammonium salts such as ammonium chloride and ammonium sulfate.

[0059] As the inorganic salt, sodium chloride is preferred from the viewpoint of further enhancing the effects of the present invention.

[0060] The inorganic salts may be commercially available. The inorganic salts may be used alone or in combination of two or more.

[0061] The content of inorganic salts in the ophthalmic composition according to the present embodiment is not particularly limited, and is appropriately set depending on the type of inorganic salts, the type and content of other blended components, the use and formulation form of the ophthalmic composition, etc. From the viewpoint of more significantly exhibiting the effects of the present invention, the content of inorganic salts is, for example, preferably 0.01 to 10 w / v%, more preferably 0.05 to 8 w / v%, even more preferably 0.08 to 5 w / v%, and particularly preferably 0.1 to 3 w / v%, based on the total amount of the ophthalmic composition according to the present embodiment.

[0062] The pH of the ophthalmic composition according to the present embodiment is not particularly limited as long as it is within a medicamentously, pharmacologically (pharmaceutical) or physiologically acceptable range. From the viewpoint of further enhancing the effect of the present invention, the pH of the ophthalmic composition according to the present embodiment is, for example, preferably 5 to 9, more preferably 5.5 to 8.5, and even more preferably 6 to 8.

[0063] The ophthalmic composition according to the present embodiment can be adjusted to an osmotic pressure ratio within a range acceptable to the living body, if necessary. The appropriate osmotic pressure ratio can be appropriately set depending on the formulation form, method of use, etc. of the ophthalmic composition, but from the viewpoint of further enhancing the effect of the present invention, it is preferably 0.5 to 2, more preferably 0.7 to 1.8, and even more preferably 0.9 to 1.6. The osmotic pressure ratio is the ratio of the osmotic pressure of the sample to 286 mOsm (the osmotic pressure of a 0.9 w / v% sodium chloride aqueous solution) based on the 17th revised Japanese Pharmacopoeia, and the osmotic pressure is measured with reference to the osmometric method (freezing point depression method) described in the Japanese Pharmacopoeia. The standard solution for measuring osmolality ratios (0.9 w / v% sodium chloride aqueous solution) can be prepared by drying sodium chloride (Japanese Pharmacopoeia standard reagent) at 500-650°C for 40-50 minutes, allowing it to cool in a desiccator (silica gel), accurately measuring 0.900 g of it, and dissolving it in purified water to make exactly 100 mL; alternatively, a commercially available standard solution for measuring osmolality ratios (0.9 w / v% sodium chloride aqueous solution) can be used.

[0064] The viscosity of the ophthalmic composition according to the present embodiment is not particularly limited as long as it is within a medicamentarily, pharmacologically (pharmaceutical) or physiologically acceptable range. The viscosity of the ophthalmic composition according to the present embodiment is preferably 1 to 20 mPa·s, more preferably 1 to 15 mPa·s, and even more preferably 1 to 10 mPa·s, as measured at 20°C using a rotational viscometer (TV-20 type viscometer, manufactured by Toki Sangyo Co., Ltd., rotor: 1°34'×R24).

[0065] The ophthalmic composition according to the present embodiment may contain an appropriate amount of a combination of various pharmacologically active ingredients and physiologically active ingredients in addition to the above-mentioned ingredients, as long as the effects of the present invention are not impaired. The ingredients are not particularly limited, and examples thereof include active ingredients in ophthalmic drugs listed in the 2017 edition of the General Drug Manufacturing and Sales Approval Standards (supervised by the Japan Society of Regulatory Science). Specific examples of ingredients used in ophthalmic drugs include the following ingredients. Antiallergic agents other than cromoglycic acid or its salts: for example, tranilast, pemirolast potassium, ashitazanolast, amlexanox, ibudilast, etc. Antihistamines other than chlorpheniramine and its salts: for example, diphenhydramine or a salt thereof (e.g., diphenhydramine hydrochloride), iproheptine or a salt thereof (e.g., iproheptine hydrochloride), levocabastine or a salt thereof (e.g., levocabastine hydrochloride), ketotifen or a salt thereof (e.g., ketotifen fumarate), pemirolast potassium, olopatadine or a salt thereof (e.g., olopatadine hydrochloride), epinastine or a salt thereof (e.g., epinastine hydrochloride), etc. Steroids: for example, fluticasone propionate, fluticasone furoate, mometasone furoate, beclomethasone propionate, flunisolide, etc. Decongestants: for example, tetrahydrozoline hydrochloride, naphazoline hydrochloride, epinephrine, epinephrine hydrochloride, ephedrine hydrochloride, phenylephrine hydrochloride, dl-methylephedrine hydrochloride, and the like. Ocular muscle regulating drugs: For example, cholinesterase inhibitors having an active center similar to that of acetylcholine, specifically, neostigmine methylsulfate, tropicamide, helenien, atropine sulfate, pilocarpine hydrochloride, etc. Anti-inflammatory agents: for example, methyl salicylate, glycol salicylate, tranexamic acid, lysozyme, lysozyme chloride, indomethacin, pranoprofen, ibuprofen, ibuprofen piconol, ketoprofen, felbinac, bendazac, piroxicam, bufexamac, butyl flufenamate, allantoin, epsilon-aminocaproic acid, berberine chloride, berberine sulfate, azulene sulfonic acid or a salt thereof (e.g., sodium azulene sulfonate), glycyrrhizic acid or a salt thereof (e.g., dipotassium glycyrrhizinate, monoammonium glycyrrhizinate), and the like. Vitamins: For example, retinol acetate, retinol palmitate, tocopherol acetate, flavin adenine dinucleotide sodium, pyridoxine hydrochloride, calcium pantothenate, cyanocobalamin, etc. Others: For example, sulfamethoxazole, sulfisoxazole, sulfisomidine and their salts.

[0066] In the ophthalmic composition according to this embodiment, various additives may be appropriately selected according to the formulation form, and one or more types may be used in combination in an appropriate amount, as long as the effect of the present invention is not impaired. Examples of such additives include, for example, various additives listed in the Pharmaceutical Additives Encyclopedia 2021 (edited by the Japan Pharmaceutical Additives Association). Representative components include the following additives. Carrier: For example, an aqueous solvent such as water or aqueous ethanol. Bases: For example, octyldodecanol, titanium oxide, potassium bromide, plastibase, etc. pH adjusters: for example, hydrochloric acid, acetic acid, sodium hydroxide, potassium hydroxide, calcium hydroxide, magnesium hydroxide, triethanolamine, monoethanolamine, diisopropanolamine, etc. Surfactants: for example, nonionic surfactants such as polyoxyethylene hydrogenated castor oil, polyoxyethylene castor oil, polyoxyl stearate, poloxamers, polyoxyethylene sorbitan fatty acid esters, tyloxapol, etc.; anionic surfactants such as polyoxyethylene alkyl ether phosphates, polyoxyethylene alkyl ether sulfates, alkylbenzene sulfonates, alkyl sulfates, N-acyltaurine salts, etc.; zwitterionic surfactants such as lauryl dimethylaminoacetate betaine, etc. Fragrances or freshening agents: for example, menthol, menthone, camphor, borneol, geraniol, cineole, citronellol, carvone, anethole, eugenol, limonene, linalool, linalyl acetate, thymol, cymene, terpineol, pinene, camphene, isoborneol, fenchene, nerol, myrcene, myrcenol, linalool acetate, lavandulol, eucalyptus oil, bergamot oil, fennel oil, cinnamon oil, rose oil, camphor oil, etc. These may be in the d-, l- or dl-form. Stabilizers: for example, sodium formaldehyde sulfoxylate (Rongalit), aluminum monostearate, glycerin monostearate, cyclodextrin, monoethanolamine, dibutylhydroxytoluene, etc. Preservatives: for example, alkyl polyaminoethyl glycine quaternary ammonium salts (e.g., benzalkonium chloride, benzethonium chloride, etc.), chlorhexidine gluconate, polydonium chloride, sodium benzoate, ethanol, chlorobutanol, sorbic acid, potassium sorbate, sodium dehydroacetate, methyl parahydroxybenzoate, ethyl parahydroxybenzoate, propyl parahydroxybenzoate, butyl parahydroxybenzoate, oxyquinoline sulfate, phenethyl alcohol, benzyl alcohol, biguanide compounds (specifically, polyhexanide hydrochloride (polyhexamethylene biguanide), alexidine, etc.), Glokill (trade name, manufactured by Rhodia), etc. Oils: For example, vegetable oils such as sesame oil, castor oil, soybean oil, olive oil, etc.; animal oils such as squalane, etc.; mineral oils such as liquid paraffin, Vaseline, etc.

[0067] Since the ophthalmic composition according to this embodiment can exhibit the effects of the present invention more significantly, it is preferable that the total content of dibutylhydroxyanisole and dibutylhydroxytoluene is less than 0.005 w / v% based on the total amount of the ophthalmic composition.

[0068] The ophthalmic composition according to this embodiment preferably does not contain benzalkonium or a salt thereof (for example, benzalkonium chloride), since the effects of the present invention can be more significantly exhibited.

[0069] The ophthalmic composition according to this embodiment preferably does not contain sorbic acid or a salt thereof (for example, sodium sorbate, potassium sorbate) since the effects of the present invention can be more significantly exhibited.

[0070] From the viewpoint of further enhancing the effects of the present invention, the ophthalmic composition of this embodiment preferably does not contain at least one selected from the group consisting of chlorhexidine and its salts (e.g., chlorhexidine hydrochloride, chlorhexidine acetate, chlorhexidine gluconate), alexidine and its salts (e.g., alexidine dihydrochloride), polyhexamethylene biguanide and its salts (e.g., polyhexamethylene biguanide hydrochloride), and polyaminopropyl biguanide and its salts (e.g., polyaminopropyl biguanide hydrochloride), and it is more preferable that the ophthalmic composition does not contain chlorhexidine and its salts, alexidine and its salts, polyhexamethylene biguanide and its salts, and polyaminopropyl biguanide and its salts.

[0071] It is preferable that the ophthalmic composition of this embodiment does not contain a calcium salt (e.g., calcium chloride, calcium sulfate) and / or a zinc salt (e.g., zinc chloride, zinc sulfate), since this allows the effects of the present invention to be more pronounced.

[0072] It is preferable that the ophthalmic composition according to this embodiment does not contain pranoprofen, since this allows the effects of the present invention to be more significantly exhibited.

[0073] The ophthalmic composition according to this embodiment preferably does not contain tetrahydrozoline or a salt thereof (for example, tetrahydrozoline chloride), since this allows the effects of the present invention to be more significantly exhibited.

[0074] When the ophthalmic composition of this embodiment contains water, from the viewpoint of more significantly achieving the effects of the present invention, the water content is, for example, based on the total amount of the ophthalmic composition of this embodiment, preferably 80 w / v% or more and less than 100 w / v%, more preferably 85 w / v% or more and 99.5 w / v% or less, and even more preferably 90 w / v% or more and 99.2 w / v% or less.

[0075] The water used in the ophthalmic composition according to the present embodiment may be any water that is medicamentally, pharmacologically (pharmaceutical) or physiologically acceptable. Examples of such water include distilled water, tap water, purified water, sterile purified water, water for injection, and distilled water for injection. The definitions of these are based on the 17th edition of the Japanese Pharmacopoeia.

[0076] The ophthalmic composition according to the present embodiment can be prepared by adding and mixing desired amounts of component (A), component (B), and other components as necessary to obtain desired concentrations. For example, the composition can be prepared by dissolving or dispersing those components in purified water, adjusting the pH and osmotic pressure ratio to a predetermined value, and sterilizing the composition by filtration sterilization or the like.

[0077] The ophthalmic composition according to the present embodiment is not limited in its formulation form as long as it is used in the ophthalmic field to contact with soft contact lenses. For example, it can be used as contact lens eye drops (including eye drops that can be applied while wearing soft contact lenses, and artificial tears that can be used while wearing soft contact lenses), soft contact lens eye wash (eye wash that can be used while wearing soft contact lenses), and contact lens compositions [contact lens wearing solution, contact lens care composition (contact lens disinfectant, contact lens preservative, contact lens cleaner, contact lens cleaning preservative), contact lens packaging solution, etc.]. Note that "contact lenses" includes hard contact lenses and soft contact lenses (including both ionic and non-ionic, including both silicone hydrogel contact lenses and non-silicone hydrogel contact lenses).

[0078] The method of using the ophthalmic composition according to the present embodiment is not particularly limited as long as it is a known method having a step of contacting the ophthalmic composition with a soft contact lens. For example, in the case of eye drops for soft contact lenses, an appropriate amount of the eye drops may be instilled before or during the wearing of the soft contact lens. In addition, in the case of an eyewash for soft contact lenses, an appropriate amount of the eyewash may be used for eyewash before or during the wearing of the soft contact lens. Note that eye drops for soft contact lenses or eyewash for soft contact lenses can be used for the purpose of instillation or eyewash not only when the soft contact lens is worn, but also when it is not worn. In addition, in the case of a soft contact lens wetting solution, the soft contact lens is used by contacting an appropriate amount of the wetting solution with the soft contact lens when the soft contact lens is worn. Furthermore, in the case of a soft contact lens care solution, the soft contact lens is used by immersing the soft contact lens in an appropriate amount of the care solution, or by contacting the soft contact lens with the care solution and scrubbing it.

[0079] Here, "ionic" soft contact lenses refer to those in which the molar percentage of monomers containing anions is 0.5% or more among the constituent monomers of the raw material polymer, in accordance with PSEHB / PED Notification No. 0330-6 by the Director of the Drug Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare and PSEHB / MDEL Notification No. 0330-4 by the Director of the Medical Device Evaluation and Licensing Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare "Regarding the handling of documents to be attached when applying for approval to manufacture (import) soft contact lenses and soft contact lens disinfectants" (March 30, 2021).

[0080] The "water content" of a soft contact lens refers to the proportion of water in the soft contact lens, and is specifically calculated by the following formula. Water content (%) = (weight of water / weight of soft contact lens in hydrated state) x 100 The moisture content can be measured by gravimetric methods as described in ISO 18369-4:2017.

[0081] In the ophthalmic composition according to the present embodiment, the type of soft contact lens to be applied is not particularly limited, and either silicone hydrogel contact lenses or (non-silicone) hydrogel contact lenses can be used. In another aspect, the ophthalmic composition according to the present embodiment can be applied to soft contact lenses classified into groups 1 to 4 in the Notice of the Director of the Pharmaceutical and Medical Devices Examination Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 0330-6 and the Notice of the Director of the Medical Device Examination Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labour and Welfare, No. 0330-4, "Handling of documents to be attached when applying for approval to manufacture (import) soft contact lenses and disinfectants for soft contact lenses" (March 30, 2021). Here, soft contact lenses classified into group 1 are nonionic and have a water content of less than 50%, soft contact lenses classified into group 2 are nonionic and have a water content of 50% or more, soft contact lenses classified into group 3 are ionic and have a water content of less than 50%, and soft contact lenses classified into group 4 are ionic and have a water content of 50% or more. In the ophthalmic composition of this embodiment, the type of soft contact lens to which it is applied is preferably a non-ionic contact lens, more preferably a non-ionic silicone hydrogel contact lens, and even more preferably a silicone hydrogel contact lens classified as Group 2, from the viewpoint of further enhancing the effects of the present invention.

[0082] When the ophthalmic composition according to this embodiment is an eye drop, the dosage and administration method are not particularly limited as long as they are effective and have few side effects. For example, in the case of adults (15 years of age or older) and children 7 years of age or older, 1 to 3 drops, 1 to 2 drops, or 2 to 3 drops at a time, 2 to 4 times a day or 5 to 6 times a day can be exemplified, with 1 to 2 drops or 1 to 3 drops at a time, 4 times a day or 5 to 6 times a day being preferred, and 1 to 2 drops at a time, 4 times a day being more preferred.

[0083] The ophthalmic composition according to the present embodiment is provided in an arbitrary container. The container for containing the ophthalmic composition according to the present embodiment may be a multi-dose type container for containing an amount for multiple uses, or a unit-dose type container for containing an amount for single use.

[0084] The material of the container for containing the ophthalmic composition according to the present embodiment is not particularly limited, and may be made of glass or plastic, for example. It is preferably made of plastic. Examples of plastic include polyesters such as polyethylene terephthalate, polybutylene terephthalate, and polyethylene naphthalate; polyolefins such as low-density polyethylene, high-density polyethylene, low-density polypropylene, high-density polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, polymethylpentene, cyclic olefin polymer, and cyclic olefin copolymer; polyarylate, polycarbonate, polyimide, and copolymers of monomers constituting these, and mixtures of two or more of these. When the container for containing the ophthalmic composition according to the present embodiment is a multi-dose type, the plastic is preferably polyethylene terephthalate. When the container for containing the ophthalmic composition according to the present embodiment is a unit-dose type, the plastic is preferably low-density polyethylene, high-density polyethylene, cyclic olefin polymer, cyclic olefin copolymer, and copolymers of monomers constituting these, and mixtures of two or more of these. In addition, when the plastic contains a cyclic olefin copolymer and polyethylene, the content ratio of the cyclic olefin copolymer to the polyethylene may be, for example, 50:50 to 95:5, 55:45 to 90:10, or 60:40 to 85:15. In addition, the container for storing the ophthalmic composition according to the present embodiment may be a transparent container that allows the inside of the container to be visually confirmed, or may be an opaque container that makes it difficult to visually confirm the inside of the container. A transparent container is preferable. Here, the "transparent container" includes both a colorless transparent container and a colored transparent container.

[0085] A nozzle may be attached to the container that contains the ophthalmic composition according to this embodiment. The material of the nozzle is not particularly limited, and may be made of glass or plastic, for example. It is preferably made of plastic. Examples of plastic include polyesters such as polyethylene terephthalate, polybutylene terephthalate, and polyethylene naphthalate; polyolefins such as low-density polyethylene, high-density polyethylene, low-density polypropylene, high-density polypropylene, cyclic olefin polymers, and cyclic olefin copolymers; polyarylate, polycarbonate, polyimide, and copolymers of monomers that constitute these, and mixtures of two or more of these. As the material of the nozzle, polyethylene terephthalate, polybutylene terephthalate, and polyethylene naphthalate are preferred, and polyethylene terephthalate is more preferred.

[0086] The shape and capacity of the container for containing the ophthalmic composition according to the present embodiment are not particularly limited, and may be appropriately set according to the application. For example, when the container for containing the ophthalmic composition according to the present embodiment is a unit dose type container and contains an eye drop, an eyewash used by dropping, or a contact lens wearing solution, the capacity may be, for example, 1 mL or more and 50 mL or less, preferably 2 mL or more and 40 mL or less, and more preferably 4 mL or more and 25 mL or less. In addition, when the container for containing the ophthalmic composition according to the present embodiment is a unit dose type container, the capacity may be, for example, 0.01 mL or more and 1 mL or less, preferably 0.05 mL or more and 0.8 mL or less, and more preferably 0.1 mL or more and 0.5 mL or less. Furthermore, if the container is a container for containing an eyewash or contact lens care solution using an eyewash cup, the capacity may be, for example, 40 mL or more and 600 mL or less.

[0087] The container containing the ophthalmic composition according to the present embodiment may be sealed in a housing. The housing is not particularly limited, and examples thereof include Ageless Omac (manufactured by Mitsubishi Gas Chemical Company, Inc.), Oxyguard (manufactured by Toyo Seikan Co., Ltd.), Oxydec (manufactured by Toyo Seikan Co., Ltd.), Oxycatch (manufactured by Kyodo Printing Co., Ltd.), Diamiron (manufactured by Mitsubishi Chemical Corporation), Hyster O2 (manufactured by Star Plastics Industry Co., Ltd.), and Cryovac (manufactured by Sealed Air Co., Ltd.).

[0088] When the container containing the ophthalmic composition according to the present embodiment is sealed in an enclosure, an oxygen absorber may be enclosed in the enclosure.The oxygen absorber is not particularly limited, and examples thereof include Ageless (manufactured by Mitsubishi Gas Chemical Co., Ltd.), StabilOx (manufactured by Multisorb Co., Ltd.), Wellpack (manufactured by Taisei Co., Ltd.), Everfresh (manufactured by Toriyoshi Sangyo Co., Ltd.), Oxyter (manufactured by Ueno Pharmaceutical Co., Ltd.), Keepit (manufactured by Dorancy Co., Ltd.), Kepron (manufactured by Kepron Co., Ltd.), Sansocut (manufactured by Iris Fine Products Co., Ltd.), Sansoles (manufactured by Hakuyo Co., Ltd.), Secur (manufactured by Nisso Resin Co., Ltd.), Tamotsu (manufactured by Oe Chemical Industry Co., Ltd.), Vitalon (manufactured by Tokiwa Sangyo Co., Ltd.), Modulan (manufactured by Nippon Kayaku Food Techno Co., Ltd.), Wonder Keep (manufactured by Powder Tech Co., Ltd.), and Freshness Preservation Agent C (manufactured by Toppan Printing Co., Ltd.) as is or appropriately packaged.

[0089] In the ophthalmic composition of this embodiment, the change in diameter of a soft contact lens when the soft contact lens is immersed in the ophthalmic composition is not particularly limited, but is preferably 0.2 mm or less, more preferably 0.15 mm or less, and even more preferably 0.1 mm or less, in order to further reduce discomfort when wearing the contact lens.

[0090] In the ophthalmic composition according to this embodiment, the ratio of suppression of the change in diameter of the soft contact lens when the soft contact lens is immersed in the ophthalmic composition (hereinafter also referred to as "lens diameter change suppression rate") is not particularly limited, but is preferably 10% or more. Here, the lens diameter change suppression rate in this embodiment is calculated by the following formula. [Formula] Lens diameter change inhibition rate (%) = [amount of change in diameter of a soft contact lens when the soft contact lens is immersed in a comparative composition (mm) - amount of change in diameter of the soft contact lens when the soft contact lens is immersed in the agent according to the present embodiment (mm)] / amount of change in diameter of the soft contact lens when the soft contact lens is immersed in a comparative composition (mm) × 100 Here, the comparative composition is a composition having the same composition as the ophthalmic composition according to the present embodiment except that it does not contain the component (B). In another embodiment, the comparative composition is a composition having the same composition as the ophthalmic composition according to the present embodiment except that it does not contain the component (B) and a chelating agent, etc.

[0091] An ophthalmic composition containing (A) at least one selected from the group consisting of cromoglycic acid and its salts, and (B) at least one selected from the group consisting of chlorpheniramine and its salts, inorganic antioxidants, and water-soluble polymer compounds, has the effect of significantly suppressing the change in diameter of a soft contact lens when the soft contact lens is immersed in the ophthalmic composition for soft contact lenses, characterized in that (A) at least one selected from the group consisting of cromoglycic acid and its salts, and (B) at least one selected from the group consisting of chlorpheniramine and its salts, inorganic antioxidants, and water-soluble polymer compounds are contained in the ophthalmic composition for soft contact lenses, and a method for suppressing the change in diameter of a soft contact lens when the soft contact lens is immersed in the ophthalmic composition for soft contact lenses is provided. EXAMPLES

[0092] The present invention will be specifically described below based on test examples, but the present invention is not limited to these.

[0093] <Test Example 1> The ophthalmic compositions shown in Table 1 were prepared according to a conventional method. The units of each component in Table 1 are g / 100 mL. As the soft contact lens (SCL), "Precision One" (Group 2, manufactured by Alcon), which is a non-ionic silicone hydrogel soft contact lens, was used. 4 mL of physiological saline (manufactured by Otsuka Pharmaceutical Factory) was dispensed into a 12-well plate (BD Falcon, No. 35-3043), and one soft contact lens was immersed in each well and left to stand at room temperature for 4 hours or more. After lightly wiping off the moisture from the soft contact lens with lint-free paper, the soft contact lens was placed one by one in a 10 mL PFA bottle containing 10 mL of each ophthalmic composition listed in Table 1, and left to stand at 34°C for 2 hours. Thereafter, the PFA bottle was immersed in a water bath at 20°C, and left to stand until the ophthalmic composition in the PFA bottle reached 20°C. The diameter of the soft contact lens before and after immersion in the ophthalmic composition was measured using a universal projector V-12B (Nikon Corporation), and the change in the diameter of the SCL due to immersion in the ophthalmic composition was calculated as an absolute value. The diameter of the SCL was measured by placing the SCL before immersion in the ophthalmic composition in a glass cell filled with physiological saline, and the diameter of the SCL after immersion in the ophthalmic composition was measured by placing the SCL in a glass cell filled with the ophthalmic composition. Thereafter, the inhibition rate of the change in the diameter of the ophthalmic composition of the example relative to the change in the diameter of the corresponding comparative example was calculated. Specifically, the inhibition rate of the change in the diameter of the SCL was calculated using formula 1. In the following formula 1, Comparative Example 1 was used as a control. The results are also shown in Table 1. [Formula 1] SCL diameter change inhibition rate (%) = (amount of diameter change of SCL immersed in control ophthalmic composition - amount of diameter change of SCL immersed in example ophthalmic composition) / amount of diameter change of SCL immersed in control ophthalmic composition x 100

[0094] [Table 1]

[0095] As can be seen from Table 1, the change in SCL diameter was significantly suppressed by further adding chlorpheniramine maleate, an inorganic antioxidant (sodium bisulfite, sodium thiosulfate), or a water-soluble polymer compound (hydroxypropylmethylcellulose, polyvinylpyrrolidone, sodium chondroitin sulfate) to an ophthalmic composition containing sodium cromoglycate.

[0096] <Test Example 2> The ophthalmic compositions shown in Table 2 were prepared according to a conventional method. The units of each component in Table 2 are g / 100 mL. As the soft contact lens (SCL), "Precision One" (Group 2, manufactured by Alcon), which is a non-ionic silicone hydrogel soft contact lens, was used. 4 mL of physiological saline (manufactured by Otsuka Pharmaceutical Factory) was dispensed into a 12-well plate (BD Falcon, No. 35-3043), and one soft contact lens was immersed in each well and left to stand at room temperature for 4 hours or more. After lightly wiping off the moisture from the soft contact lens with lint-free paper, each soft contact lens was placed in a 10 mL PFA bottle containing 10 mL of each ophthalmic composition listed in Table 1, and left to stand at 34°C for 2 hours. Thereafter, the PFA bottle was immersed in a water bath at 20°C, and left to stand until the ophthalmic composition in the PFA bottle reached 20°C. The diameter of the soft contact lens before and after immersion in the ophthalmic composition was measured using a universal projector V-12B (Nikon Corporation), and the change in the diameter of the SCL due to immersion in the ophthalmic composition was calculated as an absolute value. The diameter of the SCL was measured by placing the SCL before immersion in the ophthalmic composition in a glass cell filled with physiological saline, and the diameter of the SCL after immersion in the ophthalmic composition was measured by placing the SCL in a glass cell filled with the ophthalmic composition. Then, the inhibition rate of the change in the diameter of the ophthalmic composition of the example relative to the change in the diameter of the corresponding comparative example was calculated. Specifically, the inhibition rate of the change in the diameter of the SCL was calculated using formulas 2 and 3. The results are shown in Table 2. [Formula 2] SCL diameter change inhibition rate (%) = (amount of diameter change of SCL immersed in the ophthalmic composition of Comparative Example 1 - amount of diameter change of SCL immersed in the ophthalmic composition of Example 8) / amount of diameter change of SCL immersed in the ophthalmic composition of Comparative Example 1 × 100 [Formula 3] SCL diameter change inhibition rate (%) = (amount of diameter change of SCL immersed in the ophthalmic composition of Comparative Example 2 - amount of diameter change of SCL immersed in the ophthalmic composition of Example 9, 10 or 11) / amount of diameter change of SCL immersed in the ophthalmic composition of Comparative Example 2 x 100

[0097] [Table 2]

[0098] As can be seen from Table 2, by adding chlorpheniramine maleate to an ophthalmic composition containing sodium cromoglycate, the change in the diameter of the SCL was significantly suppressed (comparison between Comparative Example 2 and Example 9), and by further adding a chelating agent (disodium edetate, citric acid), the change in the diameter of the SCL was even more significantly suppressed (comparison between Comparative Example 1 and Example 8, comparison between Comparative Example 2 and Examples 10 and 11).

[0099] From the above results, it is believed that the ophthalmic composition of the present invention can suppress changes in the diameter of the SCL, and due to this effect, can reduce the discomfort felt when wearing the SCL.

Claims

1. An ophthalmic composition for soft contact lenses comprising (A) at least one member selected from the group consisting of cromoglycic acid and its salts, and (B) at least one member selected from the group consisting of chlorpheniramine and its salts, inorganic antioxidants, and water-soluble polymer compounds.

2. 2. The ophthalmic composition for soft contact lenses according to claim 1, wherein the content of component (A) is 1 to 2 w / v % based on the total amount of the ophthalmic composition.

3. 2. The ophthalmic composition for soft contact lenses according to claim 1, wherein the inorganic antioxidant is at least one selected from the group consisting of sulfurous acid and its salts, pyrosulfurous acid and its salts, hydrogen sulfite and its salts, thiosulfuric acid and its salts, and alkali metal iodides.

4. 2. The ophthalmic composition for soft contact lenses according to claim 1, wherein the water-soluble polymer compound is at least one selected from the group consisting of vinyl polymer compounds, cellulose polymer compounds, and mucopolysaccharides.

5. The ophthalmic composition for soft contact lenses according to claim 1 , further comprising a chelating agent.

6. The ophthalmic composition for soft contact lenses according to claim 1 , further comprising a buffering agent.

7. 2. The ophthalmic composition for soft contact lenses according to claim 1, which has a pH of 5 to 9.

8. 2. The ophthalmic composition for soft contact lenses according to claim 1, wherein the osmotic pressure ratio is 0.5 to 2.

9. 2. The ophthalmic composition for soft contact lenses according to claim 1, wherein the change in diameter of the lens when the soft contact lens is immersed in the composition is 0.2 mm or less.

10. The ophthalmic composition for soft contact lenses according to claim 1 , which is a nonionic ophthalmic composition for soft contact lenses.

11. A method for suppressing a change in diameter of a soft contact lens when the soft contact lens is immersed in an ophthalmic composition for soft contact lenses, the method comprising the steps of: (A) an ophthalmic composition for soft contact lenses containing at least one member selected from the group consisting of cromoglycic acid and its salts; and (B) at least one member selected from the group consisting of chlorpheniramine and its salts, inorganic antioxidants, and water-soluble polymer compounds.

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