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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-09-30

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.

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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.

Conditions

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Open-angle Glaucoma or Ocular Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group 1: DE-117 ophthalmic solution

One drop DE-117 Low Dose in each eye daily for 28 days

Group Type EXPERIMENTAL

DE-117 ophthalmic solution

Intervention Type DRUG

Group 2: DE-117 ophthalmic solution

One drop DE-117 Low Middle Dose in each eye daily for 28 days

Group Type EXPERIMENTAL

DE-117 ophthalmic solution

Intervention Type DRUG

Group 3: DE-117 ophthalmic solution

One drop DE-117 High Middle Dose in each eye daily for 28 days

Group Type EXPERIMENTAL

DE-117 ophthalmic solution

Intervention Type DRUG

Group 4: DE-117 ophthalmic solution

One drop DE-117 High Dose in each eye daily for 28 days

Group Type EXPERIMENTAL

DE-117 ophthalmic solution

Intervention Type DRUG

latanoprost ophthalmic solution

One drop latanoprost 0.005% in each eye daily for 28 days

Group Type ACTIVE_COMPARATOR

latanoprost ophthalmic solution

Intervention Type DRUG

placebo (vehicle of DE-117) ophthalmic solution

One drop DE-117 vehicle in each eye once daily for 28 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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DE-117 ophthalmic solution

Intervention Type DRUG

latanoprost ophthalmic solution

Intervention Type DRUG

Placebo

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No