NCT01279083

Safety and Efficacy Trial to Treat Open-Angle Glaucoma or Ocular Hypertension

A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.

Detailed description

This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects. Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.

Conditions

• Open-angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	DE-112	Topical ocular solution
DRUG	DE-112	Topical ocular solution
DRUG	DE-112	Topical ocular solution
DRUG	DE-112	Topical ocular solution
DRUG	DE-112 Vehicle Solution	Topical ocular solution
DRUG	Timolol Maleate Solution	Topical ocular solution

Timeline

• Start date: 2011-01-01
• Primary completion: 2011-11-01
• Completion: 2012-02-01
• First posted: 2011-01-19
• Last updated: 2012-12-17

Locations

2 sites across 1 country: United States