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Claims for Patent: 8,906,950

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Claims for Patent: 8,906,950

Title:Ketorolac tromethamine compositions for treating or preventing ocular pain
Abstract: Compositions comprising ketorolac tromethamine at a therapeutically effective concentration of less than 0.5% are disclosed herein. Methods of treating or preventing ocular pain using said compositions are also disclosed herein.
Inventor(s): Muller; Christopher A. (Foothill Ranch, CA), Cheetham; Janet K. (Laguna Niguel, CA), Kuan; Teresa H. (Placentia, CA), Power; David F. (Trabuco Canyon, CA)
Assignee: Allergan Sales, LLC (Irvine, CA)
Application Number:13/830,080
Patent Claims: 1. A method for treating ocular pain and burning by topical administration no more than four times daily of an aqueous composition comprising 0.4% w/v ketorolac tromethamine.

2. A method for treating ocular pain and burning by topical administration no more than four times daily of an aqueous topical ophthalmic composition comprising 0.4% w/v ketorolac tromethamine, from about 0.001% w/v to about 0.05% w/v edetate disodium, from about 0.004% w/v to about 0.007% w/v benzalkonium chloride, and from about 0.001% w/v to about 0.005% w/v Octoxynol-40, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH from about 7.2 to about 7.6.

3. A method for treating ocular pain and burning by topical administration no more than four times daily of an aqueous composition comprising 0.4% w/v ketorolac tromethamine, about 0.015% w/v edetate disodium, about 0.006% w/v benzalkonium chloride, about 0.003% w/v Octoxynol-40, about 0.79% w/v sodium chloride, and an effective amount of sodium hydroxide and/or hydrochloric acid to adjust the pH to from about 7.2 to about 7.6.

4. A method for treating ocular pain and burning by topical administration no more than four times daily of an aqueous composition comprising 0.4% w/v ketorolac tromethamine as its sole active ingredient, wherein said method is substantially as effective as topical administration of a second composition comprising 0.5% w/v ketorolac tromethamine as its sole active ingredient at the same dosing frequency.

5. The method of claim 4, wherein said method also provides reduced ocular side effects as compared to topical administration of said second composition comprising 0.5% w/v ketorolac tromethamine as its sole active ingredient at the same dosing frequency.

6. The method of claim 1, wherein the ocular pain and burning is caused by corneal refractive surgery, cataract surgery, or allergic conjunctivitis.

7. The method of claim 2, wherein the ocular pain and burning is caused by corneal refractive surgery, cataract surgery, or allergic conjunctivitis.

8. The method of claim 3, wherein the ocular pain and burning is caused by corneal refractive surgery, cataract surgery, or allergic conjunctivitis.

9. The method of claim 4, wherein the ocular pain and burning is caused by corneal refractive surgery, cataract surgery, or allergic conjunctivitis.

10. The method of claim 5, wherein the reduction in ocular side effects includes at least one side effect selected from the group consisting of ocular discomfort, ocular irritation, ocular stinging, ocular burning, and foreign body sensation.

11. The method of claim 2, wherein said method is substantially as effective as topical administration of a second composition comprising 0.5% w/v ketorolac tromethamine as its sole active ingredient at the same dosing frequency.

12. The method of claim 3, wherein said method is substantially as effective as topical administration of a second composition comprising 0.5% w/v ketorolac tromethamine as its sole active ingredient at the same dosing frequency.

13. The method of claim 11, wherein said method also provides reduced ocular side effects as compared to topical administration of said second composition comprising 0.5% w/v ketorolac tromethamine as its sole active ingredient at the same dosing frequency.

14. The method of claim 12, wherein said method also provides reduced ocular side effects as compared to topical administration of said second composition comprising 0.5% w/v ketorolac tromethamine as its sole active ingredient at the same dosing frequency.

15. The method of claim 13, wherein the reduction in ocular side effects includes at least one side effect selected from the group consisting of ocular discomfort, ocular irritation, ocular stinging, ocular burning, and foreign body sensation.

16. The method of claim 14, wherein the reduction in ocular side effects includes at least one side effect selected from the group consisting of ocular discomfort, ocular irritation, ocular stinging, ocular burning, and foreign body sensation.
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