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To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Placebo Comparator |
| |
| 4 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-104 medium concentration | Drug | Topical ocular application |
| |
| DE-104 high concentration |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the safety and efficacy of two concentrations of DE-104 ophthalmic solution with placebo and 0.005% latanoprost in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension. | 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension. | 15 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Artesia | California | 90701 | United States | |||
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 17, 2017 | |
| Reset | May 25, 2017 |
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| Drug |
Topical ocular application |
|
| Placebo | Drug | Topical ocular application |
|
| 0.005% latanoprost | Drug | Topical ocular application |
|
| Pasadena |
| California |
| 91105 |
| United States |
| San Francisco | California | 94102 | United States |
| Honolulu | Hawaii | 96814 | United States |
| Kailua | Hawaii | 96734 | United States |
| New York | New York | 10016 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2017 | May 25, 2017 |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D011461 | Prostaglandins F, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |
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