Contact lens cleaning agent

Abstract

The present invention relates to a lipase-containing composition for cleaning contact lenses, in particular soft contact lenses, where the composition contains a lipase obtainable from Candida rugosa.

Description

[0001] This application is a divisional application of the invention patent application filed on January 22, 2018, with application number 201880007646.9 and invention title "Contact Lens Cleaner".

[0002] This invention relates to the use of lipase-containing compositions for cleaning soft contact lenses, to water-soluble solid contact lens cleaners, and to methods of using lipases as a means of removing metabolic deposits in or on soft contact lenses, or for assisting in the cleaning of soft contact lenses in water-soluble solid contact lens cleaners.

[0003] Contact lenses remain very popular among people with myopia. The issue of proper care remains a concern with contact lens use. Various systems are known, but they all essentially share the common problem of needing to disinfect contact lenses after wear, primarily at night, using chemical agents. Because these chemicals are corrosive, they must be neutralized before the lenses can be worn again. To address this, various care agents have been developed on the market, such as aqueous solutions of hydrogen peroxide as disinfectant solutions, which are then neutralized or decomposed in subsequent stages. Different systems are known in the prior art for this purpose, such as catalytic decomposition on precious metal surfaces, by means of enzymatic decomposition such as catalase, and chemical neutralization by reducing hydrogen peroxide with sodium thiosulfate. Similarly, the problem of removing metabolic deposits, particularly protein deposits, from lenses or lens materials has been largely addressed in the prior art. For example, agents containing proteases are added during the initial cleaning stage. For soft contact lenses, Bacillus subtilis protease should be specifically mentioned as a protease for removing protein deposits from the contact lens matrix. EP 0 219 220 A can be considered representative of the prior art. It describes a combined contact lens care solution that both disinfects and cleans contact lenses. Disinfection is achieved through a hydrogen peroxide solution and a protease active in a peroxide-containing solution. Subtilisin is considered to be one such protease.

[0004] Removing metabolic deposits, especially protein deposits, from the contact lens matrix is ​​crucial because these deposits can cause changes in the lens matrix, ranging from alterations in optical properties to the onset of inflammation.

[0005] Despite the availability of different systems on the market, the care of soft contact lenses appears to be so complicated that people have started selling so-called disposable contact lenses.

[0006] In this context, cleaning and disinfection are no longer the focus, as contact lenses are simply discarded after a period of wear. However, on the other hand, since individual customization of contact lenses involves prohibitively high costs, only pre-made, mass-produced products are available, making dedicated disposable lenses economically impractical. Nevertheless, when individual adaptation is disregarded, contact lenses with suboptimal properties are provided to the appropriate patient.

[0007] EP 009 374 has documented tablets for cleaning contact lenses, which contain trypsin, alpha amylase and lipase.

[0008] WO 98 / 37921A1 relates to a contact lens care agent containing, in addition to peroxide-degrading enzymes such as catalase, Bacillus subtilis protease, and the release of these enzymes in an aqueous solution used for cleaning contact lenses. The advantage of these systems is that they eliminate the need for a separate cleaning stage prior to sterilization using protease.

[0009] WO 03 / 013621A describes a system for cleaning contact lenses, which may contain proteases, lipases and amylases.

[0010] WO 01 / 54834A1, EP 0 456 467 A2 and WO 86 / 04083A1 disclose the use of pancreatic enzymes, which are multi-enzyme complexes with proteolytic, lipolytic and starch-hydrolyzing activities.

[0011] EP 0 279 401 A2 discloses the use of pancreatic lipase and microbial lipase for removing deposits in contact lenses.

[0012] WO 97 / 00963A1 discloses the use of lipases to break down lipids into fatty acids and alcohols.

[0013] Conventional contact lens care products using existing technology cannot satisfactorily remove deposits.

[0014] In particular, cholesterol deposits have shown adaptation.

[0015] Therefore, one object of the present invention is to provide a contact lens care agent that avoids the aforementioned problems. In particular, it is necessary to reduce or substantially remove cholesterol deposits in soft contact lenses.

[0016] This invention is based on the unexpected discovery that lipases available from Candida albicans can remove deposits, particularly cholesterol deposits, that cannot be satisfactorily removed with conventional contact lens care products.

[0017] Therefore, the present invention relates to a lipase-containing composition for cleaning contact lenses, particularly soft contact lenses, characterized in that the composition contains a lipase obtainable from Candida rugosa. This lipase is also known as pancreatic lipase.

[0018] Lipase is an enzyme that breaks down lipids (triglycerides). In addition, lipase is responsible for hydrolyzing retinyl esters into retinol and fatty acids.

[0019] Surprisingly, it has been found that the lipase contained in the composition of the present invention can also be used to remove cholesterol deposits in soft hydrophilic contact lenses, although cholesterol is not a triglyceride and does not have any structural elements that are usually attacked by lipases.

[0020] One embodiment of the present invention is characterized in that the lipase is a lipase with Enzyme Committee number: 3.1.1.3.

[0021] In another embodiment of the present invention, the contact lens is a soft contact lens.

[0022] The lipase used in the composition of the present invention can reduce cholesterol deposits on and in contact lenses until the cholesterol deposits can be completely removed.

[0023] Figure 1 The contact lens care agent of the present invention is shown.

[0024] Figure 2A and 2B Other embodiments of the contact lens care agent of the present invention are shown.

[0025] Figures 3A(1 and 2)-C(1 and 2) illustrate the use of the contact lens care product of the present invention and the use of commercially available contact lens care products that do not contain the lipases of the composition of the present invention. Avizor (Spain), results of treating contact lenses contaminated with cholesterol deposits. Figure 3A (1 and 2): Biovision / Cooper Optics / monthly disposable, worn for one month; Figure 3B (1 and 2): Rios No.7, Biovision / Cooper Optics / monthly disposable, worn for one month; Figure 3C (1 and 2): PureVision 2HD / Bausch & Lomb, silicone hydrogel, worn for three consecutive days.

[0026] The composition is used simply by reacting it with the contact lenses to be cleaned in an aqueous solution. The aqueous solution preferably has a buffering effect to facilitate lipase activity. In this case, the ionic strength of the solution can be adjusted by the buffer salt or other components contained therein, in particular, without adversely affecting, but rather optimizing, the lipase activity.

[0027] Buffer salts used to adjust the pH to favor lipase activity can be added to the aqueous phase, to which the composition used in this invention is incorporated. The same applies to components that adjust ionic strength, unless the pH-buffering component has already been adjusted to a suitable ionic strength.

[0028] If the composition used according to the invention is itself in an aqueous phase, it can be added to the contact lens to be cleaned, which is typically present in a medium that is essentially physiological and corresponds to the tear environment.

[0029] The compositions of the present invention can also be in solid form, such as tablets. Lipases are formulated naturally in a manner familiar to those skilled in the art. For example, lipases can be formulated in physiologically safe solids used for formulating freeze-dried proteins, particularly water-soluble sugars such as tablets. The tablet matrix may also contain substances that can be used to adjust pH and ionic strength. In one embodiment of the compositions of the present invention, particularly in tablet form, it contains catalase, sodium chloride, buffer salts familiar to those skilled in the art, and formulation adjuvants, such as granulating agents. In addition to the lipases essential in the compositions of the present invention, other enzymes, such as proteases (e.g., subtilisin or amylase), may also be included in the compositions. This applies to both liquid and solid formulations of the compositions of the present invention.

[0030] Lipase is typically present in doses of 0.1 mg to 1.5 mg per tablet, particularly 0.4 mg per tablet. Catalase is typically present in doses of 0.02 mg to 2 mg per tablet. Subtilisin is typically present in doses of 0.05 mg to 5 mg per tablet.

[0031] The lipase suitable for the compositions of the present invention is commercially available, for example, under the name AY30, CAS No. 9001-62-1, Acros Organic.

[0032] The tablets described in WO 98 / 37921A1 are particularly suitable for formulations of the compositions of the present invention.

[0033] Therefore, the present invention also relates to a water-soluble solid contact lens care agent 1, having at least one first compartment 2 and one second compartment 3, wherein the first compartment 2 contains at least one agent for removing or assisting in cleaning cholesterol-containing metabolic deposits on the contact lens, and the second compartment 3 contains at least one agent capable of neutralizing a contact lens disinfectant solution, wherein the first compartment 2 dissolves in the contact lens disinfectant solution more quickly than the second compartment 3, and wherein both compartments 2 and 3 can be simultaneously exposed to the contact lens disinfectant solution. The contact lens care agent is characterized in that the agent for removing or assisting in cleaning cholesterol-containing metabolic deposits on the contact lens is a lipase, particularly a lipase obtained from *Candida cruzi* with Enzyme Committee Number: 3.1.1.3.

[0034] According to the present invention, a contact lens care solution having two compartments 2,3 is preferred.

[0035] In another embodiment of the invention, the contact lens care agent is characterized in that the first compartment 2 concentrically surrounds the second compartment 3. Figure 1 A cross-sectional view of the contact lens care agent of the present invention is shown.

[0036] In another embodiment of the invention, the contact lens care agent is characterized in that the first compartment 2 does not surround the second compartment 3 on all sides. Figure 2A ).

[0037] In another embodiment of the invention, the contact lens care agent is characterized in that it is a molded product having two mutually perpendicular axes, wherein the first compartment 2 is arranged around the first axis, and the second compartment 3 is arranged around the second axis. Figure 2B ).

[0038] In another embodiment of the invention, the contact lens care agent is characterized in that, in addition to the lipase, the first compartment 2 also contains a protease.

[0039] The present invention also relates to the use of a lipase obtained from *Candida foldii* in a water-soluble solid contact lens care agent 1 having at least one first compartment 2 and at least one second compartment 3 as an agent for removing or assisting in cleaning cholesterol-containing metabolic deposits on contact lenses, comprising at least one first compartment 2 for removing or assisting in cleaning cholesterol-containing metabolic deposits on contact lenses, and at least one second compartment 3 for neutralizing a contact lens disinfectant solution, wherein the first compartment 2 dissolves more rapidly in the contact lens disinfectant solution than the second compartment 3, and wherein both compartments 2 and 3 can be simultaneously exposed to the contact lens disinfectant solution.

[0040] One embodiment of the use of the present invention is characterized in that two compartments 2,3 are present in the contact lens care solution.

[0041] In another embodiment of the invention, the first compartment 2 of the contact lens care solution does not surround the second compartment 3 of the contact lens care solution.

[0042] Another embodiment of the invention is characterized in that the first compartment 2 of the contact lens care agent concentrically surrounds the second compartment 3 of the contact lens care agent.

[0043] According to another embodiment of the invention, the contact lens care agent is a molded product having two mutually perpendicular axes, wherein the first compartment 2 of the contact lens care agent is arranged around the first axis, and the second compartment 2 of the contact lens care agent is arranged around the second axis.

[0044] The method for cleaning contact lenses is similar to that for using traditional cleaning agents.

[0045] The application of the composition used in this invention is automatically activated.

[0046] Unless these disclosures contradict the teachings of this invention, all cited references are incorporated herein by reference in their entirety.

[0047] The present invention is further illustrated by the following embodiments. Example

[0048] The tablet-form composition of the present invention, containing 0.4 mg of lipase (AY30, CAS No. 9001-62-1, Acros Organic, Thermo Fisher Scientific, Hull, Belgium) and subtilisin, was tested and compared with a known lipase-free composition (EverClean, manufacturer: Ultron (Madrid, Spain)), with all other components identical. The composition of the present invention achieves higher cleaning performance than the known lipase-free composition.

[0049] Comparison of soft, worn and uncleaned silicone hydrogel monthly disposable lenses (BioVision / Cooper Optics / Monthly Disposable and PureVision 2HD / Bausch & Lomb / Silicone Hydrogel) before and after cleaning with EverClean and the composition of the present invention.

[0050] Wear Baishiming / monthly disposable contact lenses (No.1, Figure 3A (1 and 2) and No.7, Figure 3B (1 and 2)) for 30 days and clean them with EverClean (commercially available combination solution).

[0051] PureVision 2HD / silicone hydrogel contact lenses were worn continuously for 3 days without being cleaned during this period (Figure 3C (1 and 2)).

[0052] Based on the amount of residue on the same contact lens, the cleaning performance of EverClean and EverClean plus the composition of the present invention was compared. For this purpose, the two halves were separated in the middle and analyzed under a microscope before and after treatment, and the results were recorded in digital form.

[0053] The amount of residue on the surface of contact lenses treated with EverClean compared to other treatments of the composition of the present invention:

[0054] 1. The test lens was split in half to ensure that the conditions of the two cleaning devices were identical. Before cleaning, both halves of the lens were examined under a digital microscope at magnification of M=100 (100x magnification) and the results were recorded. One half was treated with EverClean overnight, while the other half was simultaneously treated with the composition of this invention. No other cleaning steps were performed.

[0055] 2. After appropriate cleaning, examine both halves again under the same microscope at the same magnification and record the findings. Directly compare and record the surface residue on both halves.

[0056] 3. Half of the sample treated with EverClean was then treated with the composition of the present invention. The cleaning results were also recorded under a microscope and directly compared with the initial condition.

[0057] Test results show that both products can not only clean contact lenses, but also regenerate them, with the composition of the present invention having a cleaning ability exceeding that of EverClean.

[0058] This can be attributed to the additional ingredients in the tablets. In addition to removing proteins that are metabolically deposited during wear of the contact lens matrix from the tear environment on its surface, the composition of the present invention can also remove cholesterol deposits.

[0059] Another stage neutralizes the 3% peroxide in the carrier solution used for disinfection to form brine. The final stage typically involves an indicator that turns the carrier fluid yellow after the neutralization process to ensure safety.

[0060] The cleaning time is 2 hours and is automatically activated, thus avoiding additional cleaning and manual handling that could adversely affect the surface of the contact lenses.

[0061] Maintaining the integrity of the contact lens surface and routine cleaning and regeneration are important standards for the health of the anterior eye area and are crucial for subsequent contact lens care.

[0062] In all experimental operations, the improved cleaning performance of the compositions of the present invention can be observed in direct comparison with EverClean.

[0063] Professional adjustments should utilize a care system that achieves optimal cleaning results and ensures the health of the anterior eye area.

[0064] This requirement is especially important when contact lenses are worn for longer than recommended times or for several consecutive nights, which is common, not exceptional, among people using alternative systems.

Claims

1. A water-soluble solid contact lens care agent (1) having at least one first compartment (2) and at least one second compartment (3), comprising an agent in at least one first compartment (2) for removing or assisting in cleaning cholesterol-containing metabolic deposits on contact lenses, and an agent in at least one second compartment (3) capable of neutralizing a contact lens disinfectant solution, wherein, The first compartment (2) dissolves more rapidly in the contact lens disinfection solution than the second compartment (3), wherein both compartments (2,3) can be exposed to the contact lens disinfection solution simultaneously, characterized in that the reagent used to remove or assist in cleaning cholesterol-containing metabolic deposits on contact lenses is a lipase, with enzyme committee number 3.1.1.

3.

2. The contact lens care agent as described in claim 1, characterized in that, There are two compartments (2,3).

3. The contact lens care agent as described in claim 1 or 2, characterized in that, The first compartment (2) does not surround the second compartment (3) on all sides.

4. The contact lens care agent as described in claim 3, characterized in that, The first compartment (2) concentrically surrounds the second compartment (3).

5. The contact lens care agent as described in claim 3 or 4, characterized in that, The contact lens care agent is a molded body with mutually perpendicular axes, wherein the first compartment (2) is arranged around a first axis and the second compartment (3) is arranged around a second axis.

6. The contact lens care agent according to any one of claims 1 to 5, characterized in that, In addition to the lipase, the first compartment (2) also contains a protease.

7. The composition according to claim 1, characterized in that, The lipase content is 0.1 to 1.5 mg per tablet, especially 0.4 mg per tablet.

8. The composition according to claim 7, characterized in that, It also contains catalase, with the catalase content ranging from 0.02 to 2 mg per tablet.

9. The composition according to claim 7, characterized in that, It also contains subtilisin, in an amount of 0.05 to 5 mg per tablet.

10. Use of a lipase, designated by the Enzyme Committee 3.1.1.3, in a water-soluble solid contact lens care agent having at least one first compartment (2) and at least one second compartment (3) as an agent for removing or assisting in cleaning cholesterol-containing metabolic deposits on contact lenses, comprising an agent in at least one first compartment (2) for removing or assisting in cleaning cholesterol-containing metabolic deposits on contact lenses, and an agent in at least one second compartment (3) capable of neutralizing a contact lens disinfectant solution, wherein, The first compartment (2) dissolves more rapidly in the contact lens disinfectant solution than the second compartment (3), wherein both compartments (2,3) can be exposed to the contact lens disinfectant solution simultaneously.

11. The use as described in claim 10, characterized in that, The contact lens care solution contains two compartments (2, 3).

12. The use as described in any one of claims 10 or 11, characterized in that, The first compartment (2) of the contact lens care solution does not have a second compartment (3) that surrounds the contact lens care solution.

13. The use as described in claim 12, characterized in that, The first compartment (2) of the contact lens care solution is concentrically surrounded by the second compartment (3) of the contact lens care solution.

14. The use as described in claim 12 or 13, characterized in that, The contact lens care solution is a molded body having two mutually perpendicular axes, wherein the first compartment (2) of the contact lens care solution is arranged around the first axis, and the second compartment (3) of the contact lens care solution is arranged around the second axis.

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