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A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure. The Null hypothesis is that the ocular hypotensive efficacy of each dose of AR-102 Ophthalmic Solution will not be different from that of its vehicle.
A double-masked, randomized, vehicle-controlled, dose-response study assessing the safety and ocular hypotensive efficacy of AR-102 in subjects with elevated intraocular pressure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-102 0.003% Ophthalmic Solution | Experimental | q.d. ocular |
|
| AR-102 0.005% Ophthalmic Solution | Experimental | q.d. ocular |
|
| AR-102 0.01% Ophthalmic Solution | Experimental | q.d. ocular |
|
| AR-102 0.03% Ophthalmic Solution | Experimental | q.d. ocular |
|
| AR-102 Vehicle Ophthalmic Solution | Experimental | q.d. ocular |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AR-102 0.003% Ophthalmic Solution | Drug |
| ||
| AR-102 0.005% Ophthalmic Solution |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint will be mean change from baseline in intraocular pressure at each time point. | One week |
| Measure | Description | Time Frame |
|---|---|---|
| The primary safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject questionnaires | One week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Van Haarlem, MD | Aerie Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Soilsh Practice | Pasadena | California | 91105 | United States | ||
| Bacharach practice |
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| Drug |
|
| AR-102 0.01% Ophthalmic Solution | Drug |
|
| AR-102 0.03% Ophthalmic Solution | Drug |
|
| AR-102 Vehicle Ophthalmic Solution | Drug |
|
| Petaluma |
| California |
| 94954 |
| United States |
| Hernando Eye Institute | Brooksville | Florida | 34613 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Mundorf Practice | Charlotte | North Carolina | 28204 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Texan Eye | Austin | Texas | 78731 | United States |
| Medical Center Ophthalmology Associates | San Antonio | Texas | 78240 | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| 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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