A Phase III Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost Ophthalmic Solution in Subjects With OAG or OHT
Overview
The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.
Full Title of Study: “A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Compared With Latanoprost Ophthalmic Solution 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension- PEONY Study”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Single (Investigator)
- Study Primary Completion Date: January 2019
Interventions
- Drug: DE-117
- DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
- Drug: Latanoprost ophthalmic solution
- Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
Arms, Groups and Cohorts
- Experimental: DE-117 ophthalmic solution
- Active Comparator: Latanoprost ophthalmic solution 0.005%
Clinical Trial Outcome Measures
Primary Measures
- Mean Diurnal IOP at Month 3
- Time Frame: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
- The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Secondary Measures
- IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)
- Time Frame: 09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.
- The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
- Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)
- Time Frame: Week 1
- The IOP (mmHg) measured in the study eye (identified at Day 1 [baseline]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
Participating in This Clinical Trial
Inclusion Criteria
- Patients with open angle glaucoma or ocular hypertension in both eyes Exclusion Criteria:
- Patients at risk of progression of visual field loss – Patients with severe visual field defect – Patients with any diseases that preclude participation in this study for safety reasons
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Santen Pharmaceutical Co., Ltd.
- Provider of Information About this Clinical Study
- Sponsor
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