Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine if the Punctum Plug Delivery System (PPDS) is safe and effective in controlling intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Low Latanoprost-PPDS |
|
| 2 | Experimental | Medium Latanoprost-PPDS |
|
| 3 | Experimental | High Latanoprost-PPDS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost-PPDS | Drug | Control of IOP compared to baseline for the low dose of Latanoprost-PPDS for 4 months or until loss of efficacy |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP change from baseline | 12 Weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | 90701 | United States | |||
Not provided
Not provided
Not provided
Not provided
Not provided
| Latanoprost-PPDS | Drug | Control of IOP compared to baseline for the medium dose of Latanoprost-PPDS for 4 months or until loss of efficacy |
|
| Latanoprost-PPDS | Drug | Control of IOP compared to baseline for the high dose of Latanoprost-PPDS for 4 months or until loss of efficacy |
|
| Sacramento |
| California |
| 95815 |
| United States |
| Bel Air | Maryland | 21014 | United States |
| Minneapolis | Minnesota | 55404 | United States |
| St Louis | Missouri | 63131 | United States |
| Lynbrook | New York | 11563 | United States |
| High Point | North Carolina | 27262 | United States |
| Philadelphia | Pennsylvania | 19148 | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
Not provided
Not provided