Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this dose-escalation study is to evaluate the safety, tolerability and efficacy of AMA0076 in reduction of intraocular pressure in subjects with ocular hypertension or primary open-angle glaucoma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 - AMA0076 Dose A (or vehicle) | Experimental | Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo). |
|
| Cohort 2: AMA0076 Dose B (or vehicle) | Experimental | Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (12 active : 3 placebo). |
|
| Cohort 3: AMA0076 Dose C (or vehicle) | Experimental | Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo). |
|
| Cohort 4: AMA0076 Dose D (or vehicle) | Experimental | Consecutive, eligible subjects who meet the inclusion/exclusion criteria in each cohort will be randomized to active or placebo (vehicle) in a 4:1 allocation ratio (20 active : 5 placebo). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMA0076 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| intraocular pressure change from baseline. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events as a measure of safety/tolerability | 4 weeks | |
| IOP assessments at weekly visits | Weeks 1, 2, 3, 4 |
Not provided
Inclusion Criteria include:
Exclusion Criteria include:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia Clinical Site - Site 02 | Artesia | California | United States | |||
| Inglewood Clinical Site - Site 03 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug |
|
| Inglewood |
| California |
| United States |
| Petaluma Clinical Site - Site 05 | Petaluma | California | United States |
| New Haven Clinical Site - Site 01 | New Haven | Connecticut | United States |
| Atlanta Clinical Site - Site 04 | Atlanta | Georgia | United States |
| High Point Clinical Site - Site 06 | High Point | North Carolina | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided