CONTACT LENS PRODUCT WITH CORNEA REPAIR FUNCTION

Abstract

A contact lens product having a cornea repair function includes a composition in the form of a solution. The composition includes gold nanoparticles and at least one auxiliary repairing ingredient. The gold nanoparticles are present in an effective concentration from 0.01 ppm to 3000 ppm and have an average particle size from 0.01 nm to 100 nm. The at least one auxiliary repairing ingredient is selected from the group consisting of chondroitin sulfate, α-lipoic acid, 2-aminoethanesulfonic acid, and potassium L-aspartate and present in an amount greater than 0 wt % and less than 20 wt % based on the composition being 100 wt %.

Claims

1. A contact lens product having a cornea repair function, comprising a composition in the form of a solution that includes gold nanoparticles and at least one auxiliary repairing ingredient, wherein the gold nanoparticles are present in an effective concentration from 0.01 ppm to 3000 ppm and have an average particle size from 0.01 nm to 100 nm, and the at least one auxiliary repairing ingredient is selected from the group consisting of chondroitin sulfate, α-lipoic acid, 2-aminoethanesulfonic acid, and potassium L-aspartate and present in an amount greater than 0 wt % and less than 20 wt % based on the composition being 100 wt %.

2. The contact lens product according to claim 1, further comprising a contact lens that is immersed in the composition.

3. The contact lens product according to claim 1, wherein the effective concentration of the gold nanoparticles is from 1 ppm to 400 ppm, and the average particle size of the gold nanoparticles is from 0.5 nm to 40 nm.

4. The contact lens product according to claim 1, wherein the amount of the at least one auxiliary repairing ingredient is from 0.05 wt % to 3 wt %.

5. The contact lens product according to claim 1, wherein the gold nanoparticles are surface-modified with a hydrophilic functional group that includes at least one of OH moiety, CONH moiety, CONH2 moiety, and COOH moiety.

6. The contact lens product according to claim 1, wherein the gold nanoparticles are surface-modified with a phenol group-containing compound that is selected from monophenol, polyphenol, and flavonoid compounds.

7. The contact lens product according to claim 1, wherein the gold nanoparticles are surface-modified with a polysaccharide substance that is selected from uronic acids, methyl carboxylic acid chitin, methyl carboxylic acid chitosan, alginic acid, and hyaluronic acid.

8. The contact lens product according to claim 1, wherein the gold nanoparticles are surface-modified with a peptide substance having a molecular weight from 300 Daltons to 300,000 Daltons.

9. The contact lens product according to claim 1, wherein the gold nanoparticles have lipoic acid or dihydrolipoic acid bonded thereon.

10. The contact lens product according to claim 1, wherein the composition has a pH from 6 to 8 and an osmotic pressure from 240 osmol/kg to 400 osmol/kg.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The described embodiments may be better understood by reference to the following description and the accompanying drawings, in which:

[0021] FIG. 1 is a partial schematic view of a contact lens product of the present disclosure;

[0022] FIG. 2 is another partial schematic view of a contact lens product of the present disclosure;

[0023] FIG. 3 is still another partial schematic view of a contact lens product of the present disclosure;

[0024] FIG. 4 is a perspective view of a contact lens product according to an exemplary embodiment of the present disclosure; and

[0025] FIG. 5 is a sectional view of the contact lens product according to the exemplary embodiment of the present disclosure.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

[0026] The present disclosure is more particularly described in the following examples that are intended as illustrative only since numerous modifications and variations therein will be apparent to those skilled in the art. Like numbers in the drawings indicate like components throughout the views. As used in the description herein and throughout the claims that follow, unless the context clearly dictates otherwise, the meaning of “a,” “an” and “the” includes plural reference, and the meaning of “in” includes “in” and “on.” Titles or subtitles can be used herein for the convenience of a reader, which shall have no influence on the scope of the present disclosure.

[0027] The terms used herein generally have their ordinary meanings in the art. In the case of conflict, the present document, including any definitions given herein, will prevail. The same thing can be expressed in more than one way. Alternative language and synonyms can be used for any term(s) discussed herein, and no special significance is to be placed upon whether a term is elaborated or discussed herein. A recital of one or more synonyms does not exclude the use of other synonyms. The use of examples anywhere in this specification including examples of any terms is illustrative only, and in no way limits the scope and meaning of the present disclosure or of any exemplified term. Likewise, the present disclosure is not limited to various embodiments given herein. Numbering terms such as “first,” “second” or “third” can be used to describe various components, signals or the like, which are for distinguishing one component/signal from another one only, and are not intended to, nor should be construed to impose any substantive limitations on the components, signals or the like.

[0028] In order to increase the protection and repair abilities of cells (e.g., cornea cells) in different layered tissues of an eye, the present disclosure provides a contact lens product having a cornea repair function. The contact lens product of the present disclosure includes a composition that mainly includes gold nanoparticles and at least one auxiliary repairing ingredient. When the contact lens product is in use, an effective amount of the gold nanoparticles and the at least one auxiliary repairing ingredient can be transferred to an eye surface area by contacting the composition with the eye surface area. Furthermore, the gold nanoparticles and the at least one auxiliary repairing ingredient can produce the synergistic effect of cornea repair. As used herein, the term “eye surface area” includes a cornea, a conjunctiva, a tear film and their adjacent or related structures.

[0029] More specifically, the contact lens product of the present disclosure can be the related products of contact lenses. The composition can be in a solution form, for example, it can serve as a package solution, a storage solution, a cleaning solution or a care solution of the contact lenses. However, such examples are not intended to limit the present disclosure.

[0030] In the present embodiment, the effective concentration of the gold nanoparticles can be from 0.01 ppm to 3000 ppm, preferably from 0.05 ppm to 1600 ppm, and more preferably from 1 ppm to 400 ppm. For example, the effective concentration of the gold nanoparticles is 5 ppm, 10 ppm, 15 ppm, 20 ppm, 25 ppm, 50 ppm, 75 ppm, 100 ppm, 150 ppm, 200 ppm, 250 ppm, 300 ppm, or 350 ppm. As used herein, the term “effective concentration” is a concentration that can deliver a sufficient amount of the gold nanoparticles to the eye surface area to produce beneficial effects.

[0031] It has been found that the gold nanoparticles at least have the functions or effects of antioxidation, antiinflammation, antiallergy, relief, corneal repair, and vascular proliferation inhibition. Therefore, the contact lens product, in which the composition includes the gold nanoparticles, can effectively maintain a user's eyes in a healthy and comfortable state.

[0032] Referring to FIG. 1 and FIG. 2, the composition includes a dispersion medium 200 for dispersing the gold nanoparticles. The dispersion medium 200 of the composition can be water, but it is not limited thereto. The content of the dispersion medium 200 can be from 75 wt % to 99 wt %, preferably from 85 wt % to 99 wt %, based on 100 wt % of the composition. As shown in FIG. 2, a number of the gold nanoparticles 100 in the composition can be grouped together to form a gold nanocluster 100′. The average particle size of the gold nanoparticles 100 or gold nanoclusters 100′ is from 0.01 nm to 100 nm, and preferably from 0.5 nm to 40 nm.

[0033] Referring to FIG. 3, the gold nanoparticles 100 or gold nanoclusters 100′ can be surface-modified with at least one functional molecular group according to practical implementations. That is, the gold nanoparticles 100 or gold nanoclusters 100′ have the at least one functional molecular group attached onto their surfaces to increase the functionality thereof. The at least one functional molecular group can be selected from the group consisting of hydrophilic functional groups, phenol group-containing compounds, polysaccharide substances, peptide substances with at least one NH2 or COOH moiety, and thiol ligands, but it is not limited thereto. The content of the at least one functional molecular group can be greater than 0 wt % and less than 20 wt % based on 100 wt % of the composition, preferably from 0.01 wt % to 5 wt %, and more preferably from 0.05 wt % to 3 wt %.

[0034] It is worth mentioning that the gold nanoparticles 100 or gold nanoclusters 100′ surface-modified with one or more hydrophilic functional groups have good hydrophilicity. The gold nanoparticles 100 or gold nanoclusters 100′ surface-modified with one or more phenol group-containing compounds, preferably with at least one of monophenol, polyphenol, and flavonoid compounds, can regulate the concentration of glutathione in cells. The gold nanoparticles 100 or gold nanoclusters 100′ surface-modified with one or more polysaccharide substances or peptide substances with at least one NH2 or COOH moiety can not only meet the requirements of biological safety, but also increase the abilities of free radical resistance and moisture retention. The gold nanoparticles 100 or gold nanoclusters 100′ surface-modified with one or more thiol ligands have an increased antioxidative ability.

[0035] In the present embodiment, the hydrophilic functional groups can include at least one of OH moiety, CONN moiety, CONH2 moiety, and COOH moiety. The polysaccharide substances can include uronic acids, methyl carboxylic acid chitin, methyl carboxylic acid chitosan, alginic acid, and hyaluronic acid. The peptide substances have a molecular weight from 300 Daltons to 300,000 Daltons. The thiol ligands such as lipoic acid and dihydrolipoic acid can have SH moiety. However, such examples are not intended to limit the present disclosure.

[0036] The content of the at least one the auxiliary repairing ingredient can be greater than 0 wt % and less than 20 wt %, preferably from 0.001 wt % to 5 wt %, more preferably from 0.005 wt % to 3 wt %, based on 100 wt % of the composition. For example, the content of the auxiliary repairing ingredient is 0.01 wt %, 0.05 wt %, 0.1 wt %, 0.2 wt %, 0.3 wt %, 0.4 wt %, 0.5 wt %, 0.6 wt %, 0.7 wt %, 0.8 wt %, 0.9 wt %, 1.0 wt %, 1.5 wt %, 2.0 wt %, or 2.5 wt %.

[0037] In the present embodiment, the at least one auxiliary repairing ingredient can be selected from the group consisting of chondroitin sulfate, α-lipoic acid, 2-aminoethanesulfonic acid, and potassium L-aspartate, but it is not limited thereto. It is worth mentioning that such substances can promote the microcirculation of layered tissues of an eyeball, which can promote cell metabolism, increase oxygen content in cells, and nourish an eye portion, and especially, can activate cellular respiration at edges of an eye and provide cool and comfortable sensations to the eye. Furthermore, such substances and the gold nanoparticles or nanoclusters (hereinafter referred to as “a nano-gold ingredient”) can work with each other under different mechanisms to produce unexpected effects.

[0038] The composition can further include a buffering agent, a surfactant, a hydrophilic polymer, an active pharmaceutical ingredient, and other functional additives. The buffering agent can be added to adjust the pH and osmolality of the composition, so as to allow the composition to have desired effects, i.e., beneficial effects for the eyes. The pH of the composition can be from 6 to 8, and preferably from 7 to 8. The osmolality of the composition can be from 240 osmol/kg to 400 osmol/kg, and preferably from 260 osmol/kg to 340 osmol/kg.

[0039] In the present embodiment, the buffering agent can be a borate buffer or a phosphate buffer. The content of the buffering agent can be greater than 0 wt % and less than 5 wt % based on 100 wt % of the composition, e.g., 0.5 wt %, 1 wt %, 1.5 wt %, 2 wt %, 2.5 wt %, 3 wt %, 3.5 wt % or 4 wt %. The borate buffer may include boric acid, sodium chloride, and a borate such as sodium tetraborate, but it is not limited thereto. The phosphate buffer may include sodium chloride and phosphates such as sodium dihydrogen phosphate, disodium hydrogen phosphate, potassium dihydrogen phosphate, and dipotassium hydrogen phosphate, but it is not limited thereto.

[0040] The surfactant can act to remove eye discharge and improve blurred vision. Furthermore, the surfactant can act to enhance the performance of the nano-gold ingredient. The surfactant can be at least one selected from polysorbate 80 (also known as Tween 80), an alkyl sulfosuccinate (e.g., SBFA 30), sodium lauroyl lactylate, polyoxypropylene glycol, polyoxyethylene hardened castor oil, and polyvinylpyrrolidone (PVP), but it is not limited thereto. The content of the surfactant can be from 0.01 wt % to 5 wt %, preferably from 0.01 wt % to 3 wt %, based on 100 wt % of the composition, e.g., 0.5 wt %, 1 wt %, 1.5 wt %, 2 wt % or 2.5 wt %.

[0041] The hydrophilic polymer can act to increase eye moisture. Furthermore, the hydrophilic polymer can act to enhance the slow release effect of the nano-gold ingredient and prolong the in-eye residence time of the nano-gold ingredient, so as to provide beneficial effects to the eyes. The hydrophilic polymer can be at least one selected from polyethylene glycol (PEG400), 2-methacryloyloxyethyl phosphorylcholine (MPC), and hyaluronic acid, but it is not limited thereto. The content of the hydrophilic polymer can be from 0.01 wt % to 5 wt %, preferably from 0.01 wt % to 3 wt %, based on 100 wt % of the composition, e.g., 0.5 wt %, 1 wt %, 1.5 wt %, 2 wt % or 2.5 wt %.

[0042] The active pharmaceutical ingredient can be added to provide antiinflammatory, antiallergic and alleviative effects. The active pharmaceutical ingredient can be at least one selected from pranoprofen, ε-aminocaproic acid, allanton, berberine, sodium azulene sulfonate, glycyrrhizic acid, sodium cromoglycate, and zinc sulfate. The content of the active pharmaceutical ingredient can be from 0.001 wt % to 20 wt % based on 100 wt % of the composition, e.g., 0.01 wt %, 0.05 wt %, 1 wt % or 10 wt %. In the present embodiment, the composition can include 0.001 wt % to 5 wt % of pranoprofen, 0.001 wt % to 5 wt % of ε-aminocaproic acid, 0.001 wt % to 5 wt % of allanton, 0.001 wt % to 10 wt % of berberine, 0.001 wt % to 10 wt % of glycyrrhizic acid, 0.001 wt % to 10 wt % of sodium cromoglycate or 0.001 wt % to 10 wt % of zinc sulfate, which serve as the active pharmaceutical ingredient, but the present disclosure is not limited thereto.

[0043] The functional additives can include an antibacterial agent and a vitamin, but they are not limited thereto. The content of the functional additive can be from 0.01 wt % to 5 wt % based on 100 wt % of the composition. Specific examples of the antimicrobial agent include polyhexamethylene biguanide (PHMB) and its water soluble salts and polyaminopropyl biguanide (PAPB) and its water soluble salts. Specific examples of the vitamin include vitamin B6 (pyridoxine hydrochloride), vitamin B12 (cyanocobalamin), and vitamin E (synthetic dl-alpha-tocopherol). However, such examples are not intended to limit the present disclosure.

[0044] Referring to FIG. 4 and FIG. 5, a contact lens product 300 according to a preferable embodiment of the present disclosure is shown, which includes a package structure 310, a package solution 320 resulted from the composition and a contact lens 330. The package solution 320 and the contact lens 330 are sealed together in the package structure 310 and are sterilized (e.g., sterilized at high temperature or high pressure), in which the contact lens 330 is immersed in the package solution 320.

[0045] More specifically, the package structure 310 includes a container 311 and a cover sheet 312. The container 311 is used to accommodate the package solution 320 and the contact lens 330. The cover sheet 312 is peelably bonded to the container 311 to seal its opening. In the present embodiment, the container 311 may be made of a plastic, and provides a reasonable degree of protection to the contact lens 330. The cover sheet 312 may be made of a metal or a plastic. The contact lens 330 may be made of a hydrogel or a silicone hydrogel, and may contain one or more functional materials if necessary, such as a blue light absorbing ingredient and a UV absorbing ingredient. However, such examples are not intended to limit the present disclosure.

[0046] It is worth mentioning that when the contact lens 330 is immersed in the package solution 320, beneficial ingredients in the package solution 320 would enter the contact lens 330 or adhere onto the contact lens 330. Therefore, when the contact lens 330 is put on an eye of a person, the beneficial ingredients can be transferred to an eye surface area from the contact lens 330, so as to prevent and treat common cornea injuries and relieve eye discomfort symptoms such as eye pain, photophobia, watery eyes, blurred vision, and vascular proliferation.

Evaluation Areas

[0047] Preparation of Ophthalmic Products:

Contact lens package solutions were prepared according to the compositions of Examples 1-4 and Comparative Example 1 as shown in Table 1. Hydrogel contact lenses produced by the Pegavision Corporation were respectively immersed in the contact lens package solutions. After sealing and high temperature sterilizing (125° C., 30 minutes) treatments, the contact lens products were obtained.

[0048] The comparison between Examples 1-4 and Comparative Example 1 of Table 1 were obtained by ten clinical trial subjects each wearing the contact lenses to conduct a self-awareness evaluation by a questionnaire. Evaluation items were divided into positive and negative groups, and each thereof was scored immediately after putting on the contact lenses and after wearing for four hours. The results are shown in Table 2, in which the score for each evaluation item is an average value of ten scores.

[0049] Since the contact lenses are medical devices that must have biocompatibility, cytotoxicity is an initial test indicator. Therefore, an in-vitro cytotoxicity test in accordance with the ISO 10993-5:2009 standard is conducted to confirm whether or not test objects have cytotoxicity to mouse fibroblasts (cell line L929). The test objects include the package solutions and the contact lenses. The cytotoxicity was graded from 0 to 4 in accordance with Table 1: “Qualitative morphological grading of cytotoxicity of extracts” of the ISO 10993-5:2009 standard; Grade “0” represents no reactivity, Grade “1” represents slight reactivity and a cell variability of less than 20%, Grade “2” represents mild reactivity and a cell variability of less than 50%, Grade “3” represents moderate reactivity and a cell variability of less than 70%, and Grade “4” represents severe reactivity and a nearly complete or complete destruction of cell layers. The results are shown in Table 3.

[0050] In recent years, smartphones and LED light sources which emit blue light have become more and more popular. In addition, the eyes of an outdoor worker may suffer from blue light damage as a result of long periods of direct exposure to sunlight. However, prolonged exposure to blue light may result in the damage or death of cornea cells. More severely, macular degeneration, blurred vision, distortion vision or dark shadows in central vision may occur in the eyes. Therefore, it is very important for eye health to block blue light, so that products with blue light protection have become more and more popular. The International Journal of Ophthalmology published in 2017 mentioned that eye cells contain reduced glutathione (GSH), which is an antioxidant of human body and is present in the lens, cornea, optic nerve, retina, and ciliary body in high concentrations. GSH can combine with free radicals by thiol groups to form an acidic substance that is easily metabolized, thereby accelerating the excretion of the free radicals. Furthermore, thiol groups of unstable lens proteins can be inhibited, and thus the incidence rate of cataract can be reduced and the development of keratopathy and retinopathy can be controlled. These are beneficial for maintaining the transparency of the cornea or lens and tissue regeneration and repair. The contact lens product of the present disclosure can be used to increase the antioxidative ability of the eye surface area, maintain the concentration of reduced glutathione (GSH) in the eye cells, and block blue light, thereby effectively preventing eye diseases and protecting the eyes from blue light.

[0051] In the comparison between Example 4 and Comparative Example 1 as shown in Table 1, blue lights were used to irradiate corneal cells in the contact lenses, so as to quantify the content of GSH in the corneal cells in a defense mode. The degree of cell damage was observed for verification. The selected cell line was bovine cornea endothelial cells. The experimental method was to inoculate corneal endothelial cells on a 12-well cell culture plate for 12 hours. Subsequently, the corneal endothelial cells were respectively added into the contact lenses to be immersed the compositions of Example 4 and Comparative Example 1 and then irradiated with blue lights (3 W) for 24 hours. After that, the four observed states of the cells were used to detect the GSH content of the cells, in which the damaged cells would have a reduced GSH content. The test results are shown in Table 4.

TABLE-US-00001 TABLE 1 Comparative Examples Example Composition 1 2 3 4 1 Borate buffer bal. bal. bal. bal. bal. solution Hyaluronic acid 0.01% 0.01% 0.01% 0.01% 0.01% Lipoic acid 0.01% 0.01% Gold 0-150 0-150 nanoparticles ppm ppm Thiol ligand- 0-150 modified gold ppm nanoparticles

TABLE-US-00002 TABLE 2 Clinical self- Compar- awareness evaluation ative (Average value of ten Examples Example scores) Evaluation time 1 2 3 4 1 Positive Comfort Immediately 10 10 10 10 9 degree after putting on contact lenses After wearing 8 8 9 10 7 for 4 hours Visual Immediately 10 10 10 10 10 performance after putting on contact lenses After wearing 7 9 9 9 7 for 4 hours Moisture Immediately 10 10 10 10 10 sensation after putting on contact lenses After wearing 7 8 8 8 6 for 4 hours Negative Dryness Immediately 0 0 0 0 0 sensation after putting on contact lenses After wearing 3 2 2 2 3 for 4 hours Sour Immediately 0 0 0 0 0 sensation after putting on contact lenses After wearing 2 1 0 0 2 for 4 hours Itch Immediately 0 0 0 0 0 Sensation after putting on contact lenses After wearing 0 0 0 0 0 for 4 hours Foreign Immediately 0 0 0 0 0 matter after putting on sensation contact lenses After wearing 3 2 1 1 4 for 4 hours Irritation Immediately 0 0 0 0 0 sensation after putting on contact lenses After wearing 0 0 0 0 0 for 4 hours Blurred Immediately 0 0 0 0 0 vision after putting on contact lenses After wearing 3 2 1 1 3 for 4 hours

TABLE-US-00003 TABLE 3 Comparative Examples Example Cytotoxicity Grade 1 2 3 4 1 Contact lens 0 0 0 0 0 Package solution 0 0 0 0 0

TABLE-US-00004 TABLE 4 Comparative Reduced GSH conc. (%) Examples Example in cells 1 2 3 4 1 Defense mode NA NA NA 97% 20%

[0052] The compositions of Examples 1-4 of the present disclosure, in which the gold nanoparticles have no cytotoxicity in the cytotoxicity trial, have good biological safety when used in contact lens products. Furthermore, the performance of the gold nanoparticles can be enhanced in the presence of the at least one auxiliary repairing ingredient, so as to eliminate or relieve negative evaluations (e.g., eye discomfort and foreign matter sensation) of long-time contact lens wearers and to maintain their eyes in a moist and comfortable state for a long period of time. It is observed from the repair trial of the corneal endothelial cells that, the repair effects on common cornea injuries resulted from Examples 1-4 are better than the repair effect on that resulted from Comparative Example 1.

BENEFICIAL EFFECTS OF THE EMBODIMENTS

[0053] The contact lens product with a cornea repair function can prevent and treat common cornea injuries and relieve eye discomfort symptoms such as eye pain, photophobia, watery eyes, blurred vision, and vascular proliferation, by virtue of the composition in the form of a solution including gold nanoparticles and at least one auxiliary repairing ingredient, the gold nanoparticles being present in an effective concentration from 0.01 ppm to 3000 ppm and having an average particle size from 0.01 nm to 100 nm, and the at least one auxiliary repairing ingredient being selected from the group consisting of chondroitin sulfate, α-lipoic acid, 2-aminoethanesulfonic acid, and potassium L-aspartate and present in an amount greater than 0 wt % and less than 20 wt % based on the composition being 100 wt %.

[0054] Furthermore, the gold nanoparticles at least have the functions or effects of antioxidation, antiinflammation, antiallergy, alleviation, corneal repair, and vascular proliferation inhibition. Therefore, the contact lens product can effectively allow a user's eyes to stay healthy and comfortable. The nano-gold ingredient and the at least one auxiliary repairing ingredient (i.e., chondroitin sulfate, α-lipoic acid, 2-aminoethanesulfonic acid and/or potassium L-aspartate) can work with each other under different mechanisms to produce unexpected effects.

[0055] In addition, the gold nanoparticles can be surface-modified with a functional molecular group, i.e., have a functional molecular group bonded thereon, so as to increase the functionality thereof.

[0056] The foregoing description of the exemplary embodiments of the disclosure has been presented only for the purposes of illustration and description and is not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Many modifications and variations are possible in light of the above teaching.

[0057] The embodiments were chosen and described in order to explain the principles of the disclosure and their practical application so as to enable others skilled in the art to utilize the disclosure and various embodiments and with various modifications as are suited to the particular use contemplated. Alternative embodiments will become apparent to those skilled in the art to which the present disclosure pertains without departing from its spirit and scope.