Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
- Conditions
- Open-angle Glaucoma or Ocular Hypertension
- Interventions
- Registration Number
- NCT01868126
- Lead Sponsor
- Santen Inc.
- Brief Summary
The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description latanoprost ophthalmic solution latanoprost ophthalmic solution One drop latanoprost 0.005% in each eye daily for 28 days placebo (vehicle of DE-117) ophthalmic solution Placebo One drop DE-117 vehicle in each eye once daily for 28 days Group 3: DE-117 ophthalmic solution DE-117 ophthalmic solution One drop DE-117 High Middle Dose in each eye daily for 28 days Group 1: DE-117 ophthalmic solution DE-117 ophthalmic solution One drop DE-117 Low Dose in each eye daily for 28 days Group 2: DE-117 ophthalmic solution DE-117 ophthalmic solution One drop DE-117 Low Middle Dose in each eye daily for 28 days Group 4: DE-117 ophthalmic solution DE-117 ophthalmic solution One drop DE-117 High Dose in each eye daily for 28 days
- Primary Outcome Measures
Name Time Method Intraocular pressure (mmHg) Day 1, Day 8, Day 15 and Day 29 Intraocular pressure (mmHg) measurements will be collected at each visit using Goldmann applanation tonometry
- Secondary Outcome Measures
Name Time Method Adverse events Day 1, Day 8, Day 15 and Day 29 Adverse events will be assessed at each visit to evaluate safety
Ocular signs and symptoms Day 1, Day 8, Day 15 and Day 29 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