NCT02179008

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (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 five concentrations of DE-117 ophthalmic solution.

Detailed description

This is a 90-day randomized, observer-masked, active-controlled, parallel-group, multi-center, study assessing the safety and efficacy of five concentrations of DE-117 ophthalmic solution when compared to latanoprost (0.005% latanoprost) in subjects with primary open-angle glaucoma or ocular hypertension.

Conditions

• Open-angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	DE-117 Low Dose ophthalmic solution	Low Dose DE-117 ophthalmic solution
DRUG	DE-117 Low/Middle Dose ophthalmic solution	Low/Middle Dose DE-117
DRUG	DE-117 Middle Dose ophthalmic solution	Middle Dose DE-117
DRUG	DE-117 Middle/High Dose ophthalmic solution	Middle/High Dose DE-117
DRUG	DE-117 High Dose ophthalmic solution	High Dose DE-117
DRUG	latanoprost ophthalmic solution 0.005%	0.005% latanoprost

Timeline

• Start date: 2014-06-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2014-07-01
• Last updated: 2018-04-18

Locations

14 sites across 1 country: United States