A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

Conditions
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Glaucoma and Ocular Hypertension

Intervention / Treatment
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* Drug: DE-117
* Drug: 0.0015% tafluprost
* Drug: DE-117 and 0.0015% tafluprost
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, 18 years of age or older Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes Qualifying intraocular pressure (IOP) in at least one eye at Baseline Exclusion Criteria: Closed/barely open anterior chamber angle or a history of acute angle closure in either eye Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period Females who are pregnant, nursing or planning a pregnancy Presence of any abnormality or significant illness that could be expected to interfere with the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Low Dose DE-117<br>Monotherapy | Drug: DE-117<br>* Ophthalmic Solution, QD, 28 Days<br>|
| Experimental: Medium Dose DE-117<br>Monotherapy | Drug: DE-117<br>* Ophthalmic Solution, QD, 28 Days<br>|
| Experimental: High Dose DE-117<br>Monotherapy | Drug: DE-117<br>* Ophthalmic Solution, QD, 28 Days<br>|
| Experimental: Low Dose DE-117 and 0.0015% tafluprost<br>Adjunctive Therapy | Drug: DE-117 and 0.0015% tafluprost<br>* Ophthalmic Solutions, QD, 28 days<br>|
| Experimental: Med. Dose DE-117 and 0.0015% tafluprost<br>Adjunctive Therapy | Drug: DE-117 and 0.0015% tafluprost<br>* Ophthalmic Solutions, QD, 28 days<br>|
| Experimental: High Dose DE-117 and 0.0015% tafluprost<br>Adjunctive Therapy | Drug: DE-117 and 0.0015% tafluprost<br>* Ophthalmic Solutions, QD, 28 days<br>|
| Active Comparator: 0.0015% tafluprost<br>Monotherapy | Drug: 0.0015% tafluprost<br>* Ophthalmic Solution, QD, 28 days<br>|
| Placebo Comparator: Placebo<br>Monotherapy | Drug: Placebo<br>* Ophthalmic Solution, QD, 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |