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The objective of this parallel group study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMA0076 0.1% | Experimental | Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. |
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| AMA0076 0.25% | Experimental | Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. |
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| AMA0076 0.50% | Experimental | Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. |
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| Placebo | Placebo Comparator | Eligible subjects who meet the inclusion/exclusion criteria will be randomized to active or placebo (vehicle) in a 1:1:1:1 allocation ratio. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMA0076 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline in mean diurnal intraocular pressure | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Mean, mean change and percent change from baseline in intraocular pressure in both mean diurnal intraocular pressure and intraocular pressure at equivalent diurnal time points. | 4 weeks | |
| Compare the safety and tolerability of topically administered AMA0076 compared to vehicle, by evaluation of safety variables |
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Inclusion Criteria:
Exclusion Criteria:
Ophthalmic exclusion criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia Clinical - Site 11 | Artesia | California | United States | |||
| Inglewood Clinical Site - Site 15 |
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| Drug |
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Evaluation of safety variables including eye exam findings (best corrected visual acuity, biomicroscopy [including grading of conjunctival hyperemia], dilated fundus examination) adverse events, discontinuations due to adverse events, serious adverse events, and vital signs. |
| 4 weeks |
| Inglewood |
| California |
| United States |
| Petaluma Clinical Site - Site 17 | Petaluma | California | United States |
| Morrow Clinical Site - Site13 | Morrow | Georgia | United States |
| Roswell Clinical Site - Site 18 | Roswell | Georgia | United States |
| Rochester Clinical Site - Site 12 | Rochester | New York | United States |
| Slingerlands Clinical Site - Site 19 | Slingerlands | New York | United States |
| Charlotte Clinical Site - Site 14 | Charlotte | North Carolina | United States |
| High Point Clinical Site - Site 16 | High Point | North Carolina | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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