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The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.
This is a two stage study.
Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.
Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose DE-117 | Experimental | Monotherapy |
|
| Medium Dose DE-117 | Experimental | Monotherapy |
|
| High Dose DE-117 | Experimental | Monotherapy |
|
| Low Dose DE-117 and 0.0015% tafluprost | Experimental | Adjunctive Therapy |
|
| Med. Dose DE-117 and 0.0015% tafluprost | Experimental | Adjunctive Therapy |
|
| High Dose DE-117 and 0.0015% tafluprost | Experimental | Adjunctive Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DE-117 | Drug | Ophthalmic Solution, QD, 28 Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point | Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santen Investigational Site | Newport Beach | California | 92663 | United States | ||
| Santen Investigational Site |
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| 0.0015% tafluprost |
| Active Comparator |
Monotherapy |
|
| Placebo | Placebo Comparator | Monotherapy |
|
| 0.0015% tafluprost | Drug | Ophthalmic Solution, QD, 28 days |
|
| DE-117 and 0.0015% tafluprost | Drug | Ophthalmic Solutions, QD, 28 days |
|
| Placebo | Drug | Ophthalmic Solution, QD, 28 days |
|
| Deerfield Beach |
| Florida |
| 33064 |
| United States |
| Santen Investigational Site | Largo | Florida | 33773 | United States |
| Santen Investigational Site | Morrow | Georgia | 30260 | United States |
| Santen Investigational Site | Roswell | Georgia | 30076 | United States |
| Santen Investigational Site | Rochester | New York | 14618 | United States |
| Santen Investigational Site | Cleveland | Ohio | 44115 | United States |
| Santen Investigational Site | Austin | Texas | 78731 | United States |
| Santen Investigational Site | Fort Worth | Texas | 76102 | United States |
| Santen Investigational Site | San Antonio | Texas | 78240 | United States |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C485333 | tafluprost |
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