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Determine efficacy of the latanoprost punctal plug. Effect of configuration of L-PPDS placement on efficacy will also be examined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A. L-PPDS single occlusion | Experimental | Latanoprost Punctal Plug Delivery System (L-PPDS) continuous single occlusion; L-PPDS will be inserted in the lower punctum and no plug will be inserted in the upper punctum of each eye; L-PPDS will remain for a period of 14 weeks. |
|
| Group B. L-PPDS double occlusion | Experimental | Latanoprost Punctal Plug Delivery System (L-PPDS) continuous double occlusion; L-PPDS will be inserted in the lower punctum and non-therapeutic (NT) plug will be inserted in the upper punctum of each eye and both will remain for a period of 14 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost Punctal Plug Delivery System (L-PPDS) | Drug | Latanoprost Punctal Plug Delivery System (L-PPDS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| IOP change from baseline and the primary analysis time point will be the IOP assessment at Week 12 | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Eye Center | Chandler | Arizona | 85225 | United States | ||
| Arizona Glaucoma Specialists |
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| Phoenix |
| Arizona |
| 85050 |
| United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Argus Research at Cape Coral Eye Center | Cape Coral | Florida | 33904 | United States |
| Eye Associates of Fort Myers | Fort Myers | Florida | 33901 | United States |
| Indiana Universtiy - Eugene and Marilyn Glick Eye Institute Ophthalmology Center | Indianapolis | Indiana | 46202 | United States |
| Cincinnati Eye Institute | Edgewood | Kentucky | 41017 | United States |
| Great Lakes Eye Care | Saint Joseph | Michigan | 49085 | United States |
| Chu Vision Institute | Bloomington | Minnesota | 55420 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Comprehensive Eye Care, Ltd. | Washington | Missouri | 63090 | United States |
| Abrams Eye Institute | Las Vegas | Nevada | 89148 | United States |
| Ophthalmic Consultants of Long Island | Lynbrook | New York | 11563 | United States |
| Dr. Steven T. Simmons | Slingerlands | New York | 12159 | United States |
| Philadelphia Eye Associates | Philadelphia | Pennsylvania | 19148 | United States |
| Wills Eye Hospital | Phildelphia | Pennsylvania | 19107 | United States |
| University Eye Surgeons | Maryville | Tennessee | 37803 | United States |
| Total Eye Care | Memphis | Tennessee | 38119 | United States |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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