NCT01868126

Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

A Phase II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution Compared With Latanoprost and Placebo in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate the safety and efficacy of four concentrations of DE-117 ophthalmic solution.

Detailed description

This is a 28-day randomized, observer-masked, placebo-and active-controlled, parallel-group, multi-center, study investigating the safety and efficacy of four concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) and placebo (vehicle of DE-117) in subjects with primary open-angle glaucoma or ocular hypertension.

Conditions

• Open-angle Glaucoma or Ocular Hypertension

Interventions

Type	Name	Description
DRUG	DE-117 ophthalmic solution
DRUG	latanoprost ophthalmic solution
OTHER	Placebo

Timeline

• Start date: 2013-05-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2013-06-04
• Last updated: 2018-04-18

Locations

7 sites across 1 country: United States