Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

Detailed Description
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This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects. Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.

Official Title
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A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

Conditions
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Ocular Hypertension, Open-angle Glaucoma

Intervention / Treatment
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* Drug: DE-112
* Drug: DE-112
* Drug: DE-112
* Drug: DE-112
* Drug: DE-112 Vehicle Solution
* Drug: Timolol Maleate Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide signed, written informed consent 18 yeas of age and older Diagnosed with primary open-angle glaucoma or ocular hypertension Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study Meet specific Visit 2, Day 0 (Baseline)criteria at baseline Exclusion Criteria: 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Concentration 1<br> | Drug: DE-112<br>* Topical ocular solution<br>|
| Experimental: Concentration 2<br> | Drug: DE-112<br>* Topical ocular solution<br>|
| Experimental: Concentration 3<br> | Drug: DE-112<br>* Topical ocular solution<br>|
| Experimental: Concentration 4<br> | Drug: DE-112<br>* Topical ocular solution<br>|
| Placebo Comparator: Vehicle Solution<br> | Drug: DE-112 Vehicle Solution<br>* Topical ocular solution<br>|
| Active Comparator: Timolol Maleate Ophthalmic Solution<br> | Drug: Timolol Maleate Solution<br>* Topical ocular solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) | Change from baseline in mean diurnal IOP | 29 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure (IOP) | Percent change from baseline in mean diurnal IOP | 29 days |