NCT02822742
Completed
Phase 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
Overview
- Phase
- Phase 3
- Intervention
- DE-117 ophthalmic solution
- Conditions
- Primary Open Angle Glaucoma or Ocular Hypertension
- Sponsor
- Santen Pharmaceutical Co., Ltd.
- Enrollment
- 26
- Primary Endpoint
- Intraocular pressure
- Status
- Completed
- Last Updated
- 8 years ago
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.
Investigators
Eligibility Criteria
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
DE-117 is Experimental. Latanoprost is Active Comparator.
Intervention: DE-117 ophthalmic solution
DE-117 ophthalmic solution and Latanoprost
DE-117 is Experimental. Latanoprost is Active Comparator.
Intervention: Latanoprost ophthalmic solution 0.005%
Outcomes
Primary Outcomes
Intraocular pressure
Time Frame: Week 4
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