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This is a double-masked, randomized, multi-center, active-controlled, crossover comparison of the addition of AR-12286 or timolol to latanoprost in the treatment of elevated intraocular pressure (IOP).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-12286 | Experimental | AR-12286 Ophthalmic Solution 0.5% |
|
| Timolol | Active Comparator | Timolol maleate ophthalmic solution 0.5% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Latanoprost 0.005% | Drug | q.d. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | The primary efficacy endpoint will be the mean IOP across subjects within treatment group at each study visit at each post-treatment timepoint. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ocular safety | Safety endpoints will be visual acuity, objective biomicroscopic and ophthalmoscopic examination, and subjective comfort as measured by adverse events in response to subject symptom queries. | 28 days |
| Systemic safety |
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Inclusion Criteria:
Exclusion Criteria:
In either eye:
In study eye(s):
Systemic:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| David Silverstone, M.D. | New Haven | Connecticut | 06510 | United States | ||
| Coastal Research Associates, LLC |
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| AR-12286 Ophthalmic Solution 0.5% | Drug |
|
| Timolol maleate ophthalmic solution 0.5% | Drug |
|
Heart rate, and blood pressure.
| 28 days |
| Roswell |
| Georgia |
| 30076 |
| United States |
| Heart of America Eye Care, P.A. | Shawnee Mission | Kansas | 66204 | United States |
| Taustine Eye Center | Louisville | Kentucky | 40217 | United States |
| Alan L Robin, M.D. | Baltimore | Maryland | 21209 | United States |
| Comprehensive Eye Care | St Louis | Missouri | 63090 | United States |
| Rochester Ophthalmology Group | Rochester | New York | 14618 | United States |
| Glaucoma Consultants of the Capital Region | Slingerlands | New York | 12159 | United States |
| Thomas K. Mundorf, M.D. | Charlotte | North Carolina | 28204 | United States |
| Charlotte Eye Ear Nose and Throat | Charlotte | North Carolina | 28210 | United States |
| The Eye Institute | Tulsa | Oklahoma | 74104 | United States |
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | United States |
| Black Hills Regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Cataract & Glaucoma Center | El Paso | Texas | 79902 | United States |
| Stacy R. Smith, M.D. | Salt Lake City | Utah | 84117 | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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