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The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.
This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: DE-117 ophthalmic solution | Experimental | One drop DE-117 Low Dose in each eye daily for 28 days |
|
| Group 2: DE-117 ophthalmic solution | Experimental | One drop DE-117 Low Middle Dose in each eye daily for 28 days |
|
| Group 3: DE-117 ophthalmic solution | Experimental | One drop DE-117 High Middle Dose in each eye daily for 28 days |
|
| Group 4: DE-117 ophthalmic solution | Experimental | One drop DE-117 High Dose in each eye daily for 28 days |
|
| latanoprost ophthalmic solution | Active Comparator | One drop latanoprost 0.005% in each eye daily for 28 days |
|
| placebo (vehicle of DE-117) ophthalmic solution | Placebo Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-117 ophthalmic solution | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (mmHg) | Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry | Day 1, Day 8, Day 15 and Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events will be assessed at each visit to evaluate safety | Day 1, Day 8, Day 15 and Day 29 |
| Ocular signs and symptoms | Ocular symptoms and ocular signs will be collected at each visit using slit lamp biomicroscopy, dilated ophthalmoscopy, gonioscopy, automated perimetry visual field testing, corrected visual acuity and pachymetry |
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Main Inclusion Criteria:
Main Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Newport Beach | California | 92663 | United States | |||
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One drop DE-117 vehicle in each eye once daily for 28 days |
|
| latanoprost ophthalmic solution | Drug |
|
| Placebo | Other |
|
| Day 1, Day 8, Day 15 and Day 29 |
| Morrow |
| Georgia |
| 30260 |
| United States |
| Kansas City | Missouri | 64133 | United States |
| Rochester | New York | 14618 | United States |
| Cleveland | Ohio | 44115 | United States |
| Austin | Texas | 78731 | United States |
| San Antonio | Texas | 78240 | United States |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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