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
Phase 2
Completed
- Conditions
- Open-angle GlaucomaOcular Hypertension
- Interventions
- Drug: DE-117 Low Dose ophthalmic solutionDrug: DE-117 Low/Middle Dose ophthalmic solutionDrug: DE-117 Middle Dose ophthalmic solutionDrug: DE-117 Middle/High Dose ophthalmic solutionDrug: DE-117 High Dose ophthalmic solution
- Registration Number
- NCT02179008
- Lead Sponsor
- Santen Inc.
- Brief Summary
The purpose of this study is to investigate the safety and efficacy of five concentrations of DE-117 ophthalmic solution.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 184
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DE-117 Low Dose ophthalmic solution DE-117 Low Dose ophthalmic solution One drop Low Dose DE-117 in each eye QD for 90 days DE-117 Low/Middle Dose ophthalmic solution DE-117 Low/Middle Dose ophthalmic solution One drop DE-117 Low/Middle Dose ophthalmic solution in each eye QD for 90 days DE-117 Middle Dose ophthalmic solution DE-117 Middle Dose ophthalmic solution One drop Middle Dose DE-117 in each eye QD for 90 days DE-117 Middle/High Dose ophthalmic solution DE-117 Middle/High Dose ophthalmic solution One drop Middle/High Dose DE-117 in each eye QD for 90 days DE-117 High Dose ophthalmic solution DE-117 High Dose ophthalmic solution One drop High Dose DE-117 in each eye QD for 90 days latanoprost ophthalmic solution 0.005% latanoprost ophthalmic solution 0.005% One drop latanaprost in each eye QD for 90 days
- Primary Outcome Measures
Name Time Method Intraocular pressure (mmHg) Day 91 Intraocular pressure (mmHg) measurements will be collected using Goldmann applanation tonometry
- Secondary Outcome Measures
Name Time Method Number of Subjects with Adverse Events as a Measure of Safety and Tolerability Day 1, Day 8, Day 15, Day 31, Day 61 and Day 91 Adverse events will be assessed at each visit to evaluate safety