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This is a Multicenter, Randomized, Double-Masked Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Presbyopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pilocarpine Ophthalmic Topical Cream, Dose 1 | Experimental | Pilocarpine Ophthalmic Topical Cream, Dose 1 |
|
| Pilocarpine Ophthalmic Topical Cream, Dose 2 | Experimental | Pilocarpine Ophthalmic Topical Cream, Dose 2 |
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| Pilocarpine Ophthalmic Topical Cream, Dose 3 | Experimental | Pilocarpine Ophthalmic Topical Cream, Dose 3 |
|
| Placebo Ophthalmic Topical Cream | Placebo Comparator | Placebo Ophthalmic Topical Cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pilocarpine Ophthalmic Topical Cream, Dose 1 | Drug | Pilocarpine Ophthalmic Topical Cream, Dose 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Corrected Near Visual Acuity (DCNVA) | Proportion of treatment responders [subjects gaining 3 lines or more in binocular distance corrected near visual acuity (DCNVA) and not losing more than 5 letters of binocular best corrected distance visual acuity (BCDVA)] 1 hour post-dose at the Day 28 visit. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit. | Proportion of treatment responders (as defined for the primary endpoint) at 0.5, 2, 4, and 6 hours post-dose at the day 28 visit. | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glaukos Investigator | Chandler | Arizona | 85224 | United States | ||
| Glaukos Investigator |
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| Pilocarpine Ophthalmic Topical Cream, Dose 2 | Drug | Pilocarpine Ophthalmic Topical Cream, Dose 2 |
|
|
| Pilocarpine Ophthalmic Topical Cream, Dose 3 | Drug | Pilocarpine Ophthalmic Topical Cream, Dose 3 |
|
|
| Placebo Ophthalmic Topical Cream | Drug | Placebo Ophthalmic Topical Cream |
|
|
| Sun City |
| Arizona |
| 85351 |
| United States |
| Glaukos Investigator | Glendale | California | 91204 | United States |
| Glaukos Investigator | Newport Beach | California | 92663 | United States |
| Glaukos Investigator | Petaluma | California | 94954 | United States |
| Glaukos Investigator | Louisville | Kentucky | 40206 | United States |
| Glaukos Investigator | Rochester | New York | 14618 | United States |
| Glaukos Investigator | Memphis | Tennessee | 38119 | United States |
| Glaukos Investigator | Houston | Texas | 77025 | United States |
| Glaukos Investigator | San Antonio | Texas | 78229 | United States |
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D012030 | Refractive Errors |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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