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Claims for Patent: 8,377,982

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Claims for Patent: 8,377,982

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), Cheetam; Janet K. (Laguna Niguel, CA), Kuan; Teresa H. (Placentia, CA)
Assignee: Allergan Sales, LLC (Irvine, CA)
Application Number:13/434,956
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.

2. The method of claim 1, wherein the side effects include at least one side effect from the group consisting of stinging, foreign body sensation or both.

3. The method of claim 1, wherein the method comprises the step of administering four times 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 four times daily administration to an eye of a second composition comprising about 0.5% w/v ketorolac tromethamine.

4. 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.

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

6. 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.

7. The method of claim 1, wherein the side effects include at least one side effect selected from the group consisting of ocular irritation, ocular burning and ocular stinging.

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

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

10. A method of treating ocular pain and burning in a person undergoing corneal surgery, 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, wherein the method reduces ocular pain and burning 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.

11. The method of claim 10, wherein the side effects include at least one selected from the group consisting of stinging, foreign body sensation or both.

12. The method of claim 10, wherein the method comprises the step of administering four times 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 burning and results in less ocular side effects as compared to the four times daily administration to an eye of a second composition comprising about 0.5% w/v ketorolac tromethamine.

13. The method of claim 10, wherein administration of the first composition results in increased ocular comfort as compared to the administration to the eye of the second composition.

14. The method of claim 12, wherein administration of the first composition results in increased ocular comfort as compared to the administration to the eye of the second composition.

15. The method of claim 12, wherein the first composition is as effective in treating ocular pain as the second composition, despite having a lower concentration of ketorolac tromethamine.

16. The method of claim 12, wherein the side effects include at least one selected from the group consisting of ocular irritation, ocular burning and ocular stinging.

17. The method of claim 10, wherein the administration is by instillation.

18. The method of claim 10, wherein the first composition comprises edetate disodium.

19. The method of claim 10, wherein the person is experiencing ocular pain due to corneal refractive surgery.

20. The method of claim 10, wherein the first composition comprises octoxynol-40.

21. The method of claim 10, wherein the first composition has a pH of about 7.4.

22. A method of treating ocular pain and burning in a person undergoing corneal refractive surgery, the method comprising the step of administering at least once daily to an eye of the person a first composition comprising 0.4% w/v ketorolac tromethamine, wherein the method reduces ocular pain and burning 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.

23. The method of claim 22, wherein the method comprises the step of administering four times daily to an eye of the person a first composition comprising 0.4% w/v ketorolac tromethamine, wherein the method reduces ocular pain and burning and results in less ocular side effects as compared to the four times daily administration to an eye of a second composition comprising 0.5% w/v ketorolac tromethamine.

24. The method of claim 22, wherein administration of the first composition results in increased ocular comfort as compared to the administration to the eye of the second composition.

25. The method of claim 23, wherein administration of the first composition results in increased ocular comfort as compared to the administration to the eye of the second composition.

26. The method of claim 22, wherein the first composition is as effective in treating ocular pain as the second composition, despite having a lower concentration of ketorolac tromethamine.

27. The method of claim 23, wherein the side effects include at least one side effect selected from the group consisting of ocular irritation, ocular burning and ocular stinging.

28. The method of claim 22, wherein the first composition comprises BAK.

29. The method of claim 22, wherein the first composition has a pH of about 7.4.

30. The method of claim 22, wherein the first composition comprises edentate disodium and octoxynol.
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