drugset / Trial / NCT02623738

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

NCT02623738

Phase 2/3 Completed 253 enrolled Santen Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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%.

Timeline

Start
2015-12-06
Primary completion
2017-02-10
Completion
2017-02-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Latanoprost Small molecule 0.005 % Other
Subject omidenepag isopropyl Small molecule Other