NCT00868894

Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension

A Randomized, Double-masked, Placebo- and Active-controlled, Multi-Center, Dose Escalation Trial of DE-104 Ophthalmic Solution in Japanese and Non-Japanese Subjects With Primary Open-angle Glaucoma or Ocular Hypertension

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Santen Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To investigate safety, efficacy, and the dose-response relationship of DE-104 in lowering intraocular pressure in Japanese and Non-Japanese subjects with primary open-angle glaucoma or ocular hypertension.

Conditions

• Open-Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	DE-104 medium concentration	Topical ocular application
DRUG	DE-104 high concentration	Topical ocular application
DRUG	Placebo	Topical ocular application
DRUG	0.005% latanoprost	Topical ocular application

Timeline

• Start date: 2009-03-01
• Primary completion: 2010-05-01
• Completion: 2010-06-01
• First posted: 2009-03-25
• Last updated: 2011-11-03

Locations

6 sites across 1 country: United States