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Claims for Patent: 8,946,281

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Claims for Patent: 8,946,281

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:13/802,076
Patent Claims: 1. A method of treating ocular pain in a person, the method comprising the step of administering at least once daily to an eye of the person a first composition comprising about 0.4% w/v ketorolac tromethamine, wherein the method reduces ocular pain and results in less ocular side effects as compared to the at least once daily administration to an eye of a second composition comprising 0.5% w/v ketorolac tromethamine; wherein the side effects include at least one side effect selected from the group consisting of stinging and foreign body sensation.

2. The method of claim 1, wherein the first composition is administered four times daily.

3. The method of claim 1, wherein administration of the first composition results in increased ocular comfort as compared to the administration to the eye of the second composition.

4. The method of claim 2, wherein administration of the first composition results in increased ocular comfort as compared to the administration to the eye of the second composition.

5. The method of claim 1, wherein the first composition is as effective in treating ocular pain as the second composition, despite having a lower concentration of ketorolac tromethamine.

6. The method of claim 1, wherein the administration is by topical instillation.

7. The method of claim 1, wherein the first composition comprises edetate disodium.

8. The method of claim 1, wherein the person is experiencing ocular pain due to corneal refractive surgery.

9. The method of claim 1, wherein the method results in analgesic activity to the patient's eye.

10. The method of claim 1, wherein the method reduces pain and ocular stinging after ophthalmic surgery.

11. The method of claim 10, wherein the surgery is corneal refractive surgery.

12. The method of claim 1, wherein the method reduces ocular burning after ophthalmic surgery.

13. The method of claim 1 wherein the first composition comprises 0.4% ketorolac tromethamine and about 0.006% benzalkonium chloride.

14. The method of claim 1 wherein the first composition comprises 0.4% w/v ketorolac tromethamine, about 0.006% w/v benzalkonium chloride and about 0.015% w/v edetate disodium.

15. The method of claim 1 wherein the first composition comprises 0.4% w/v ketorolac tromethamine, about 0.006% w/v benzalkonium chloride, about 0.015% w/v edetate disodium and about 0.003% w/v octoxynol 40.

16. The method of claim 1 wherein the first composition comprises 0.4% w/v ketorolac tromethamine, about 0.006% w/v benzalkonium chloride, about 0.015% w/v edetate disodium, about 0.003% w/v octoxynol 40 and water.

17. The method of claim 1 wherein the first composition comprises 0.4% w/v ketorolac tromethamine, about 0.006% w/v benzalkonium chloride, about 0.015% w/v edetate disodium, about 0.003% w/v octoxynol 40, water and hydrochloric acid and sodium hydroxide to adjust the pH to about 7.4.
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