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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 Signs and Symptoms of Dry Eye Disease.
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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 |
|
| 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 |
|---|---|---|
| Mean change from baseline in the VAS score at Day 28 visit. | Mean change from baseline in the VAS score at Day 28 visit. Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort) | Baseline and Day 28 |
| Mean change from baseline in Fluorescein Staining at the Day 28 visit. | Mean change from baseline in Fluorescein Staining at the Day 28 visit. | Baseline and Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits | Mean change from baseline in the VAS score at the Day 4, 8, and 14 visits Visual Analogue Scale from 0 (no discomfort) to 100 (maximal discomfort) | Baseline and Days 4, 8, and 14 |
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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 | Mission Hills | California | 91345 | United States |
| Glaukos Investigator | Newport Beach | California | 92663 | United States |
| Glaukos Investigator | Petaluma | California | 94954 | United States |
| Glaukos Investigator | Rancho Cordova | California | 95670 | United States |
| Glaukos Investigator | Grand Junction | Colorado | 81501 | United States |
| Glaukos Investigator | Fort Myers | Florida | 33901 | United States |
| Glaukos Investigator | Roswell | Georgia | 30076 | United States |
| Glaukos Investigator | St Louis | Missouri | 63131 | United States |
| Glaukos Investigator | Henderson | Nevada | 89052 | United States |
| Glaukos Investigator | Rochester | New York | 14618 | United States |
| Glaukos Investigator | Cranberry Township | Pennsylvania | 16066 | United States |
| Glaukos Investigator | Memphis | Tennessee | 38119 | United States |
| Glaukos Investigator | Nashville | Tennessee | 37215 | United States |
| Glaukos Investigator | Houston | Texas | 77025 | United States |
| Glaukos Investigator | San Antonio | Texas | 78229 | United States |
| Glaukos Investigator | Lynchburg | Virginia | 24502 | United States |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| D005128 | Eye Diseases |
| D003316 | Corneal Diseases |
| D007637 | Keratoconjunctivitis |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D007634 | Keratitis |
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