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Claims for Patent: 9,216,167

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Claims for Patent: 9,216,167

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:14/533,798
Patent Claims: 1. A method of treating ocular pain in a patient, wherein the method comprises the administration of an ophthalmic composition comprising about 0.4% w/v ketorolac tromethamine to an eye of the patient; and wherein the administration results in little or no burning or stinging in the eye of the patient upon topical instillation of the composition.

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

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

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

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

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

7. The method of claim 1 wherein the 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.

8. The method of claim 1 wherein the 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.

9. The method of claim 1 wherein the 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.

10. The method of claim 1, wherein about one drop QID of the composition is administered to the eye of the patient.

11. A method of enhancing comfort in a patient suffering from ocular pain, wherein the method comprises the administration of an ophthalmic composition comprising about 0.4% w/v ketorolac tromethamine to an eye of the patient; and wherein the administration results in little or no burning or stinging in the eye of the patient upon topical instillation of the composition.

12. The method of claim 11, wherein the composition is administered four times daily.

13. The method of claim 11, wherein the person is experiencing ocular pain due to corneal refractive surgery.

14. The method of claim 11 wherein the composition comprises 0.4% ketorolac tromethamine and about 0.006% benzalkonium chloride.

15. The method of claim 11 wherein the composition comprises 0.4% w/v ketorolac tromethamine, about 0.006% w/v benzalkonium chloride and about 0.015% w/v edetate disodium.

16. The method of claim 11 wherein the 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.

17. The method of claim 11 wherein the 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.

18. The method of claim 11 wherein the 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.

19. The method of claim 11, wherein about one drop QID of the composition is administered to the eye of the patient.
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