Method for providing rapid disinfection of contact lenses

• US 5,965,088 A
• Filed: 10/23/1997
• Issued: 10/12/1999
• Est. Priority Date: 10/23/1997
• Status: Expired due to Term

• Current Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Original Assignee: Bausch & Lomb Incorporated (Bausch Health Cos., Inc.)
• Inventors: Lever, Andrea M., Lever, O. William Jr.
• Primary Examiner(s): Thornton, Krisanne
• Application Number:
  US08/956,514
• Time in Patent Office: 719 Days
• Field of Search: 422/28, 422/1, 514/839, 514/840, 134/901, 510/112, 424/464, 424/429
• US Class Current: 422/28
• CPC Class Codes: A61L 12/142 Polymeric biguanides

Abstract

The present invention is directed to method of disinfecting a contact lens with an ophthalmically safe disinfecting aqueous solution comprising about 2.0 to about 8.0 ppm of a bis(biguanide) having the following formula: ##STR1## wherein R¹ and R⁴ are independently selected from the group consisting of branched or unbranched alkyl having 4-12 carbon atoms, ether or thioether radical having 4-12 carbon atoms, or cycloalkyl or cycloalkyl-alky radical having 5-12 carbon atoms; R² and R³ are independently selected from the group consisting of hydrogen, alkyl having 1-12 carbon atoms, alkoxyalkyl having 1-12 carbon atoms, or cycloalkyl or cycloalkyl-alkyl having 5-12, carbon atoms; R⁶ and R⁷ are independently selected from the group consisting of hydrogen and alkyl radical having 1-6 carbon atoms, and A in the above formula is selected from the group consisting of a divalent alkyl, alkyloxyalkyl, or alkylsufide radical each having 4-12 carbon atoms. The invention is also directed to a method of cleaning and/or disinfecting a contact lens within a minimum soaking period that is not more than about 75 minutes.

Claims

1. A method of cleaning and/or disinfecting a soft contact lens comprising:

(a) rubbing the contact lens with an ophthalmically safe solution comprising the following components;

(i) a microbiocidally effective amount of the hydrorhloride salt of a bis(biguanide) in the amount of about 2.0 to about 8.0 ppm, or a corresponding molar amount of the bis(biguanide) in the form of another water-soluble salt or the free base thereof, which bis(biguanide) has the following general formula;

##STR13## wherein R¹ and R⁴ are independently selected from the group consisting of branched or unbranched alkyl having 4-12 carbon atoms, alkoxyalkyl ether or alkylsulfide thioether radical having 4-12 carbon atoms, or cycloalkyl or cycloalkyl-alkyl radical having 5-12 carbon atoms;

R² and R³ are independently selected from the group consisting of hydrogen, alkyl having 1-12 carbon atoms, alkoxyalkyl having 1-12 carbon atoms, or cycloalkyl or cycloalkyl-alkyl having 5-12 carbon atoms;

R⁶ and R⁷ are independently selected from the group consisting of hydrogen and alkyl radical having 1-6 carbon atoms, and A in the above formula is a divalent group having 4-16 carbon atoms and is selected from the group consisting of alkylene, alkyloxyalkyl, and alkylsufide radical, wherein the aforesaid alkyoxyalkyl or alkylsulfide radicals are either a polymethylene chain interrupted with one or more oxygen and/or sulfur atoms or a polymethylene chain substituted with an alkoxy (--OR⁸) or alkylthio (--SR⁹) group, wherein R⁸ and R⁹ are independently selected from the group consisting of alkyl having 1-12 carbon atoms, or a cycloalkyl or cycloalkyl-alkyl having 5-12 carbon, or wherein A is a divalent polymethylelne group having 8 to 16 carbon atoms interrupted with a divalent radical of cyclohexane or diaza-cyclohexane;

(ii) an effective amount of a buffering agent,

(iii) an effective amount of a surfactant; and

(b) soaking the rubbed contact lens from step (a) in the solution for a total period of time that is within a range of about 5 minutes to about 75 minutes; and

(c) directly placing the treated lens on an eye of the wearer, such that a rinse with a different solution is not required.

2. The method of claim 1, wherein said total period of time for soaking is within a range of about 7.5 minutes to about 60 minutes.

3. The method of claim 1, wherein said total period of time for soaking is within a range of about 10 minutes to about 45 minutes.

4. The method of claim 1, wherein said total period of time for soaking is within a range of about 10 minutes to about 30 minutes.

5. The method of claim 1, wherein the surfactant is a neutral or non-ionic surfactant in the amount of 0.01 to 5.0 percent.

6. The method of claim 1, wherein the surfactant is a neutral or non-ionic surfactant having a plurality of poly(oxyalkylene) chains, each of the poly(oxyalkylene) comprises (--OR) repeat units, wherein R is independently an alkylene having 2 to 6 carbon atoms.

7. The method of claim 6, wherein the surfactant is a neutral or non-ionic surfactant which comprises a block copolymer of poly(ethyleneoxide) and poly(propylene oxide) segments.

8. The method of claim 1, wherein the said, amount is 2.5 to 6.0 ppm.

9. The method of claim 1 wherein said amount is 3:

0 to 5.0 ppm.

10. The method of claim 1, wherein the bis(biguanide) has the following formula:

##STR14## or water-soluble salts thereof, wherein R¹ and R⁴ are independently selected from the group consisting of branched or unbranched alkyl, alkoxyalkyl ether or alkylsulfide thioether radical, and n is 5 to 7.

19. The method of claim 1 or 2, wherein the bis(biguanide) has the following formula:

##STR18## or water-soluble salts thereof, wherein R¹ and R⁴ are independently selected from the group consisting of branched or unbranched alkyl, alkoxyalkyl ether or alkylsulfide thioether radical, and n is 5 to 7.

11. A method of cleaning and/or disinfecting a contact lens comprising:

(a) rubbing the contact lens with an ophthalmically safe solution comprising the following components;

(i) microbiocidally effective amount of the hydrochloride salt of a bis(biguanide) in the amount of about 2.0 to about 8.0 ppm, or a corresponding molar amount of the bis(biguanide) in the form of another water-soluble salt or the free base thereof, which bis(biguanide) has the following general formula;

##STR15## wherein wherein R¹ and R⁴ are independently selected from the group consisting of branched or unbranched alkyl having 4-12 carbon atoms, alkoxyalkyl or alkylsulfide radical having 4-12 carbon atoms, or cycloalkyl or cycloalkyl-alkyl radical having 5-12 carbon atoms;

R² and R³ are independently selected from the group consisting of hydrogen, alkyl having 1-12 carbon atoms, alkoxyalkyl having 1-12 carbon atoms, or cycloalkyl or cycloalkyl-alkyl having 5-12 carbon atoms;

R⁶ and R⁷ are independently selected from the group consisting of hydrogen and alkyl radical having 1-6 carbon atoms, and A in the above formula is a divalent group having 4-16 carbon atoms and is selected from the group consisting of an alkylene, alkyloxyalkyl, and alkylsufide radical, wherein the aforesaid alkyoxyalkyl or alkylsulfide radicals are either a polymethylene chain interrupted with one or more oxygen and/or sulfur atoms or a polymethylene chain substituted with an alkoxy (--OR⁸) or alkylthio (--SR⁹) group, wherein R⁸ and R⁹ are independently selected from the group consisting of alkyl having 1-12 carbon atoms, or a cycloalkyl or cycloalkyl-alkyl having 5-12 carbon, or wherein A is a divalent polymethylene group having 8 to 16 carbon atoms interrupted with a divalent radical of cyclohexane or diaza-cyclohexane;

(ii) one or more polymeric biguanides in the total amount of about 0.1 to about 3.0 ppm, which polymeric biguanides have the following formula;

##STR16## wherein Z is an organic divalent bridging group which may be the same or different throughout the polymer, n is at least 3, and X¹ and X² are independently selected from the groups --NH₂ and ##STR17## (iii) an effective amount of a buffering agent;

(iv) an effective amount of a surfactant present; and

(b) soaking the rubbed contact lens from step (a) in the solution for a total period of time that is within a range of about 5 minutes to about 75 minutes; and

(c) directly placing the treated lens on an eye of the wearer, such that a rinse with a different solution is not required.

12. The method of claim 11, wherein said total period of time for soaking is within a range of about 7.5 minutes to about 60 minutes.

13. The method of claim 11, wherein said total period of time for soaking is within a range of about 10 minutes to about 30 minutes.

14. The method of claim 11, wherein the solution has a pH between 6.0 and 8.0 and further comprises an tonicity agent and a buffering agent.

15. The method of claim 11, wherein the solution comprises a surfactant that is a neutral or non-ionic surfactant.

16. The method of claim 11, wherein the surfactant is a neutral or non-ionic surfactant having a plurality of poly(oxyalkylene) chains, each of the poly(oxyalkylene) comprises (--OR) repeat units, wherein R is independently an alkylene having 2 to 6 carbon atoms.

17. The method of claim 11, wherein said amount of the bis(biguanide) is about 2.5 to about 6.0 ppm.

18. The method of claim 11, wherein said amount of the bis(biguanide) is about 3.0 to about 5.0 ppm.

20. The method of claim 11, wherein the polymeric biguanides are a mixture of polymers having the following formula:

##STR19## wherein X¹ and X² are as defined above.