Overview

A Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-

Status:
Completed
Trial end date:
2017-02-10
Target enrollment:
0
Participant gender:
All
Summary
The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Santen Pharmaceutical Co., Ltd.
Treatments:
Latanoprost
Ophthalmic Solutions
Pharmaceutical Solutions
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