Multi-center Phase II 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 five concentrations of DE-117 ophthalmic solution.

Detailed Description
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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.

Conditions
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Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: DE-117 Low Dose ophthalmic solution
* Drug: DE-117 Low/Middle Dose ophthalmic solution
* Drug: DE-117 Middle Dose ophthalmic solution
* Drug: DE-117 Middle/High Dose ophthalmic solution
* Drug: DE-117 High Dose ophthalmic solution
* Drug: latanoprost ophthalmic solution 0.005%


Participation Criteria
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Eligibility Criteria
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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 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DE-117 Low Dose ophthalmic solution<br>One drop Low Dose DE-117 in each eye QD for 90 days | Drug: DE-117 Low Dose ophthalmic solution<br>* Low Dose DE-117 ophthalmic solution<br>* Other names: DE-117;|
| Experimental: DE-117 Low/Middle Dose ophthalmic solution<br>One drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days | Drug: DE-117 Low/Middle Dose ophthalmic solution<br>* Low/Middle Dose DE-117<br>* Other names: DE-117;|
| Experimental: DE-117 Middle Dose ophthalmic solution<br>One drop Middle Dose DE-117 in each eye QD for 90 days | Drug: DE-117 Middle Dose ophthalmic solution<br>* Middle Dose DE-117<br>* Other names: DE-117;|
| Experimental: DE-117 Middle/High Dose ophthalmic solution<br>One drop Middle/High Dose DE-117 in each eye QD for 90 days | Drug: DE-117 Middle/High Dose ophthalmic solution<br>* Middle/High Dose DE-117<br>* Other names: DE-117;|
| Experimental: DE-117 High Dose ophthalmic solution<br>One drop High Dose DE-117 in each eye QD for 90 days | Drug: DE-117 High Dose ophthalmic solution<br>* High Dose DE-117<br>* Other names: DE-117;|
| Active Comparator: latanoprost ophthalmic solution 0.005%<br>One drop latanaprost in each eye QD for 90 days | Drug: latanoprost ophthalmic solution 0.005%<br>* 0.005% latanoprost<br>* Other names: latanoprost;|

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 using Goldmann applanation tonometry | Day 91 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

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