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A 28 day study of the safety and efficacy of two concentrations of topical AR-12286 in treating ocular hypertension and open-angle glaucoma compared to latanoprost. Hypothesis: The ocular hypotensive efficacy of each dose of AR-12286 ophthalmic solution will not be different from that of an active control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-12286 0.5% ophthalmic solution | Experimental |
| |
| AR-12286 0.25% Ophthalmic Solution | Experimental |
| |
| Latanoprost 0.005% ophthalmic solution | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR-12286 0.5% ophthalmic solution | Drug | q.d. PM |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint will be the mean intraocular pressure (IOP) across subjects within treatment group on each day at each post-treatment timepoint | 28 days of dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from diurnally adjusted baseline IOP at each timepoint | 28 days of dosing |
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Inclusion Criteria:
Exclusion Criteria:
Ophthalmic (in either eye):
Systemic:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas van Haarlem, MD | Aerie Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| United Medical Research Institute | Inglewood | California | 90301 | United States | ||
| North Bay Eye Associates |
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| AR-12286 0.25% Ophthalmic solution |
| Drug |
q.d. PM |
|
| Latanoprost ophthalmic solution | Drug | q.d. PM |
|
|
| Petaluma |
| California |
| 94954 |
| United States |
| Centre For Health Care | Poway | California | 92064 | United States |
| East Florida Eye Institute | Stuart | Florida | 34994 | United States |
| Marvin Greenberg, MD | Tamarac | Florida | 33321 | United States |
| Coastal Research Associates, LLC | Roswell | Georgia | 30076 | United States |
| Bradley Kwapiszeski, MD | Shawnee Mission | Kansas | 66204 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Comprehensive Eye Care | St Louis | Missouri | 63090 | United States |
| Mount Sinai School Of Medicine | New York | New York | 10029 | United States |
| Rochester Ophthalmology Group | Rochester | New York | 14618 | United States |
| Glaucoma Consultants of the Capital Region | Slingerlands | New York | 12159 | United States |
| Charlotte Eye Ear Nose and Throat | Charlotte | North Carolina | 28210 | United States |
| The Eye Institute | Tulsa | Oklahoma | 74104 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Univ Eye Surgeons, Maryville Ctr. | Maryville | Tennessee | 37803 | United States |
| Texan Eye | Austin | Texas | 78731 | United States |
| Medical Center Ophth. Associates | San Antonio | Texas | 78731 | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C581711 | AR-12286 |
| D009883 | Ophthalmic Solutions |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
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