Presbyopia treatments
Described herein are methods and compositions for the treatment of ocular conditions and for the improvement of vision parameters using pharmaceutically acceptable ophthalmic pilocarpine formulations. A nonlimiting example of an ocular condition that may be treated with the methods and compositions disclosed herein is presbyopia.
1. A method for the treatment of presbyopia in a patient in need thereof, comprising
topically administering once daily to at least one eye of the patient one drop of a pharmaceutically acceptable ophthalmic composition comprising 1.25% w/v pilocarpine hydrochloride as the sole active ingredient, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, 0.0075% w/v benzalkonium chloride, and water, and wherein the pH of the ophthalmic composition is between 3.0 to 5.5, and wherein the viscosity of the ophthalmic composition is 1 centipoise; and
wherein the administration of the pharmaceutically acceptable ophthalmic composition to the patient results in a greater improvement in near visual acuity without reduction of distance visual acuity as compared to administration of one drop of a second pharmaceutically acceptable ophthalmic composition comprising the same ingredients as the first pharmaceutically acceptable ophthalmic composition but with 0.5% w/v or less pilocarpine hydrochloride.
2. The method of claim 1 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast near vision acuity.
3. The method of claim 1 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast near vision acuity.
4. The method of claim 1 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast distance vision acuity.
5. The method of claim 1 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity.
6. The method of claim 1 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast intermediate vision acuity.
7. The method of claim 1 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity.
8. The method of any one of claims 2 to 7 , wherein the improvement from baseline has a duration of effect of at least two hours.
9. The method of any one of claims 2 to 7 , wherein the improvement from baseline has a duration of effect of at least six hours.
10. A method for the treatment of presbyopia in a patient in need thereof, comprising
topically administering once daily to at least one eye of the patient one drop of a pharmaceutically acceptable ophthalmic composition consisting of 1.25% w/v pilocarpine hydrochloride as the sole active ingredient, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, 0.0075% w/v benzalkonium chloride, and water, and wherein the pH of the ophthalmic composition is between 3.0 to 5.5, and wherein the viscosity of the ophthalmic composition is 1 centipoise; and
wherein the administration of the pharmaceutically acceptable ophthalmic composition to the patient results in a greater improvement in near visual acuity without reduction of distance visual acuity as compared to administration of one drop of a second pharmaceutically acceptable ophthalmic composition comprising the same ingredients as the first pharmaceutically acceptable ophthalmic composition but with 0.5% w/v or less pilocarpine hydrochloride.
11. The method of claim 10 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast near vision acuity.
12. The method of claim 10 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast near vision acuity.
13. The method of claim 10 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast distance vision acuity.
14. The method of claim 10 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity.
15. The method of claim 10 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast intermediate vision acuity.
16. The method of claim 10 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity.
17. The method of any one of claims 11 to 16 , wherein the improvement from baseline has a duration of effect of at least two hours.
18. The method of any one of claims 11 to 16 , wherein the improvement from baseline has a duration of effect of at least six hours.
19. A method for the treatment of presbyopia in a patient in need thereof, comprising
topically administering twice daily to at least one eye of the patient one drop of a pharmaceutically acceptable ophthalmic composition comprising 1.25% w/v pilocarpine hydrochloride as the sole active ingredient, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, 0.0075% w/v benzalkonium chloride, and water, and wherein the pH of the ophthalmic composition is between 3.0 to 5.5, and wherein the viscosity of the ophthalmic composition is 1 centipoise; and
wherein the administration of the pharmaceutically acceptable ophthalmic composition to the patient results in a greater improvement in near visual acuity without reduction of distance visual acuity as compared to administration of one drop of a second pharmaceutically acceptable ophthalmic composition comprising the same ingredients as the first pharmaceutically acceptable ophthalmic composition but with 0.5% w/v or less pilocarpine hydrochloride.
20. The method of claim 19 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast near vision acuity.
21. The method of claim 19 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast near vision acuity.
22. The method of claim 19 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast distance vision acuity.
23. The method of claim 19 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity.
24. The method of claim 19 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast intermediate vision acuity.
25. The method of claim 19 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity.
26. The method of any one of claims 20 to 25 , wherein the improvement from baseline has a duration of effect of at least two hours.
27. The method of any one of claims 20 to 25 , wherein the improvement from baseline has a duration of effect of at least six hours.
28. A method for the treatment of presbyopia in a patient in need thereof, comprising
topically administering twice daily to at least one eye of the patient one drop of a pharmaceutically acceptable ophthalmic composition consisting of 1.25% w/v pilocarpine hydrochloride as the sole active ingredient, 1.0% w/v boric acid, 0.015% w/v sodium citrate dihydrate, 0.08% w/v sodium chloride, 0.0075% w/v benzalkonium chloride, and water, and wherein the pH of the ophthalmic composition is between 3.0 to 5.5, and wherein the viscosity of the ophthalmic composition is 1 centipoise; and
wherein the administration of the pharmaceutically acceptable ophthalmic composition to the patient results in a greater improvement in near visual acuity without reduction of distance visual acuity as compared to administration of one drop of a second pharmaceutically acceptable ophthalmic composition comprising the same ingredients as the first pharmaceutically acceptable ophthalmic composition but with 0.5% w/v or less pilocarpine hydrochloride.
29. The method of claim 28 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast near vision acuity.
30. The method of claim 28 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast near vision acuity.
31. The method of claim 28 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast distance vision acuity.
32. The method of claim 28 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity.
33. The method of claim 28 , wherein the method results in an improvement from baseline under the condition of mesopic, high contrast intermediate vision acuity.
34. The method of claim 28 , wherein the method results in an improvement from baseline under the condition of photopic, high contrast intermediate vision acuity.
35. The method of any one of claims 29 to 34 , wherein the improvement from baseline has a duration of effect of at least two hours.
36. The method of any one of claims 29 to 34 , wherein the improvement from baseline has a duration of effect of at least six hours.