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To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.
Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concentration 1 | Experimental |
| |
| Concentration 2 | Experimental |
| |
| Concentration 3 | Experimental |
| |
| Concentration 4 | Experimental |
| |
| Vehicle Solution | Placebo Comparator |
| |
| Timolol Maleate Ophthalmic Solution | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-112 | Drug | Topical ocular solution |
| |
| DE-112 |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | Change from baseline in mean diurnal IOP | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (IOP) | Percent change from baseline in mean diurnal IOP | 29 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78731 | United States | |||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 14, 2017 | |
| Reset | May 19, 2017 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 14, 2017 | May 19, 2017 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Drug |
Topical ocular solution |
|
| DE-112 | Drug | Topical ocular solution |
|
| DE-112 | Drug | Topical ocular solution |
|
| DE-112 Vehicle Solution | Drug | Topical ocular solution |
|
| Timolol Maleate Solution | Drug | Topical ocular solution |
|
| San Antonio |
| Texas |
| 78207 |
| United States |