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Claims for Patent: 8,648,107

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Claims for Patent: 8,648,107

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:13/830,150
Patent Claims: 1. An aqueous topical ophthalmic composition for treating ocular pain comprising 0.4% w/v ketorolac tromethamine.

2. 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.

3. An aqueous topical ophthalmic 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. The aqueous topical ophthalmic composition of claim 1, wherein the composition is to be administered no more than 4 times per day.

5. The aqueous topical ophthalmic composition of claim 2, wherein the composition is to be administered no more than 4 times per day.

6. The aqueous topical ophthalmic composition of claim 3, wherein the composition is to be administered no more than 4 times per day.

7. The aqueous topical ophthalmic composition of claim 1, wherein the composition is useful for one or more of the following: administration following corneal refractive surgery, administration following cataract surgery, or treatment of allergic conjunctivitis.

8. An aqueous topical ophthalmic composition for treating ocular pain comprising 0.4% w/v ketorolac tromethamine as its sole active ingredient which is substantially as effective in reducing ocular pain as a second aqueous topical ophthalmic composition comprising 0.5% w/v ketorolac tromethamine as its sole active ingredient.

9. The aqueous topical ophthalmic composition of claim 8, wherein the composition provides reduced ocular side effects relative to the second composition.

10. The aqueous topical composition of claim 9, wherein the ocular side effects include 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 aqueous topical ophthalmic composition of claim 8, wherein the composition is to be administered no more than 4 times per day.

12. The aqueous topical ophthalmic composition of claim 8, wherein the composition is to be administered 4 times per day.

13. The aqueous topical ophthalmic composition of claim 9, wherein the composition is to be administered no more than 4 times per day.

14. The aqueous topical ophthalmic composition of claim 9, wherein the composition is to be administered 4 times per day.

15. The aqueous topical ophthalmic composition of claim 10, wherein the composition is to be administered no more than 4 times per day.

16. The aqueous topical ophthalmic composition of claim 10, wherein the composition is to be administered 4 times per day.

17. The aqueous topical ophthalmic composition of claim 2, wherein the composition is useful for one or more of the following: administration following corneal refractive surgery, administration following cataract surgery, or treatment of allergic conjunctivitis.

18. The aqueous topical ophthalmic composition of claim 8, wherein the composition is useful for one or more of the following: administration following corneal refractive surgery, administration following cataract surgery, or treatment of allergic conjunctivitis.

19. The aqueous topical ophthalmic composition of claim 9, wherein the composition is useful for one or more of the following: administration following corneal refractive surgery, administration following cataract surgery, or treatment of allergic conjunctivitis.

20. The aqueous topical ophthalmic composition of claim 10, wherein the composition is useful for one or more of the following: administration following corneal refractive surgery, administration following cataract surgery, or treatment of allergic conjunctivitis.
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