NCT02822742CompletedPhase 3
A Phase III, Open-label, Single-arm, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension Who Are Non-/Low-responders to Latanoprost Ophthalmic Solution: FUJI Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 26
- Primary Endpoint
- Intraocular pressure
Study Overview
Brief Summary
The purposes of this study are to investigate the effect of intraocular pressure lowering efficacy and safety of DE-117 ophthalmic solution in subjects with primary open-angle glaucoma or ocular hypertension who are non-/low-responders to latanoprost ophthalmic solution.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Primary open angle glaucoma or ocular hypertension
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
Arms & Interventions
DE-117 ophthalmic solution and Latanoprost
Other
DE-117 is Experimental. Latanoprost is Active Comparator.
Intervention: DE-117 ophthalmic solution (Drug)
DE-117 ophthalmic solution and Latanoprost
Other
DE-117 is Experimental. Latanoprost is Active Comparator.
Intervention: Latanoprost ophthalmic solution 0.005% (Drug)
Outcomes
Primary Outcomes
Intraocular pressure
Time Frame: Week 4
Secondary Outcomes
No secondary outcomes reported
Investigators
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