Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

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 four concentrations of DE-117 ophthalmic solution.

Detailed Description
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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.

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

Conditions
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Open-angle Glaucoma or Ocular Hypertension

Intervention / Treatment
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* Drug: DE-117 ophthalmic solution
* Drug: latanoprost ophthalmic solution
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Main Inclusion Criteria: Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes Qualifying intraocular pressure in at least one eye at Baseline Qualifying corrected ETDRS visual acuity in each eye Qualifying central cornea thickness in each eye Main Exclusion Criteria: Closed/barely open anterior chamber angle or a history of acute angle closure in either eye Diagnosis of primary open-angle glaucoma or ocular hypertension due to etiology known to be non-responsive to conventional drug therapy Evidence of advanced glaucoma, visual field defect or progressive visual field loss that that do not meet the study criteria History of ocular surgery specifically intended to lower IOP History of any ocular or systemic abnormality or condition that may put the subject at significant risk, may confound study results, or may interfere significantly with the subject's participation in the study Intended or current use of any ocular medications other than study medications during the study Use of contact lenses within one week prior to Baseline (Day 1) until end of treatment Known allergy or sensitivity to any components of the study medications Use of steroids (systemic) within 30 days prior to Visit 1 (Screening) Anticipate the need to initiate or modify an existing chronic therapy that could substantially affect IOP or the study outcomes during the study period Females who are pregnant, nursing or planning a pregnancy

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: Group 1: DE-117 ophthalmic solution<br>One drop DE-117 Low Dose in each eye daily for 28 days | Drug: DE-117 ophthalmic solution<br> <br> |
| Experimental: Group 2: DE-117 ophthalmic solution<br>One drop DE-117 Low Middle Dose in each eye daily for 28 days | Drug: DE-117 ophthalmic solution<br> <br> |
| Experimental: Group 3: DE-117 ophthalmic solution<br>One drop DE-117 High Middle Dose in each eye daily for 28 days | Drug: DE-117 ophthalmic solution<br> <br> |
| Experimental: Group 4: DE-117 ophthalmic solution<br>One drop DE-117 High Dose in each eye daily for 28 days | Drug: DE-117 ophthalmic solution<br> <br> |
| Active Comparator: latanoprost ophthalmic solution<br>One drop latanoprost 0.005% in each eye daily for 28 days | Drug: latanoprost ophthalmic solution<br> <br> |
| Placebo Comparator: placebo (vehicle of DE-117) ophthalmic solution<br>One drop DE-117 vehicle in each eye once daily for 28 days | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | Day 1, Day 8, Day 15 and Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Santen, Eye, Glaucoma, Ocular hypertension