NCT02822729CompletedPhase 3
A Long-term Open-label Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension : RENGE Study
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 125
- Primary Endpoint
- Evaluation of adverse events
Study Overview
Brief Summary
The purposes of this study are to evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients with open angle glaucoma or ocular hypertension.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with 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 (Group1)
Experimental
Monotherapy
Intervention: DE-117 ophthalmic solution (Drug)
DE-117 ophthalmic solution (Group2)
Experimental
Monotherapy
Intervention: DE-117 ophthalmic solution (Drug)
DE-117 ophthalmic solution + Timolol (Group3)
Other
Concomitant Use
Intervention: DE-117 ophthalmic solution (Drug)
DE-117 ophthalmic solution + Timolol (Group3)
Other
Concomitant Use
Intervention: Timolol ophthalmic solution (Drug)
Outcomes
Primary Outcomes
Evaluation of adverse events
Time Frame: Week 52
Secondary Outcomes
No secondary outcomes reported
Investigators
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