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The purpose of this study is to investigate the safety and efficacy of five concentrations of DE-117 ophthalmic solution.
This is a 90-day randomized, observer-masked, active-controlled, parallel-group, multi-center, study assessing the safety and efficacy of five concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) in subjects with primary open-angle glaucoma or ocular hypertension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DE-117 Low Dose ophthalmic solution | Experimental | One drop Low Dose DE-117 in each eye QD for 90 days |
|
| DE-117 Low/Middle Dose ophthalmic solution | Experimental | One drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days |
|
| DE-117 Middle Dose ophthalmic solution | Experimental | One drop Middle Dose DE-117 in each eye QD for 90 days |
|
| DE-117 Middle/High Dose ophthalmic solution | Experimental | One drop Middle/High Dose DE-117 in each eye QD for 90 days |
|
| DE-117 High Dose ophthalmic solution | Experimental | One drop High Dose DE-117 in each eye QD for 90 days |
|
| latanoprost ophthalmic solution 0.005% |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-117 Low Dose ophthalmic solution | Drug | Low Dose DE-117 ophthalmic solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure (mmHg) | Intraocular pressure (mmHg) measurements will be collected using Goldmann applanation tonometry | Day 91 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects with Adverse Events as a Measure of Safety and Tolerability | Adverse events will be assessed at each visit to evaluate safety | Day 1, Day 8, Day 15, Day 31, Day 61 and Day 91 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler | Arizona | 85225 | United States | |||
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| Active Comparator |
One drop latanaprost in each eye QD for 90 days |
|
| DE-117 Low/Middle Dose ophthalmic solution | Drug | Low/Middle Dose DE-117 |
|
|
| DE-117 Middle Dose ophthalmic solution | Drug | Middle Dose DE-117 |
|
|
| DE-117 Middle/High Dose ophthalmic solution | Drug | Middle/High Dose DE-117 |
|
|
| DE-117 High Dose ophthalmic solution | Drug | High Dose DE-117 |
|
|
| latanoprost ophthalmic solution 0.005% | Drug | 0.005% latanoprost |
|
|
| Artesia |
| California |
| 90701 |
| United States |
| Glendale | California | 91204 | United States |
| Long Beach | California | 90806 | United States |
| Newport Beach | California | 92663 | United States |
| Largo | Florida | 33773 | United States |
| Morrow | Georgia | 30260 | United States |
| Roswell | Georgia | 30076 | United States |
| Rochester | New York | 14618 | United States |
| High Point | North Carolina | 27262 | United States |
| Cleveland | Ohio | 44115 | United States |
| Austin | Texas | 78731 | United States |
| Houston | Texas | 77005 | 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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| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D000077338 | Latanoprost |
| ID | Term |
|---|---|
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D020313 | Specialty Uses of Chemicals |
| 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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