A Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution in Patients With POAG or OHT

• Status: Completed
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Santen Inc.
• Treatments: Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Male or Female, 18 years of age or older

2. Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes

3. Qualifying intraocular pressure (IOP) in at least one eye at Baseline

Exclusion Criteria:

1. Closed/barely open anterior chamber angle or a history of acute angle closure in either eye

2. Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period

3. Females who are pregnant, nursing or planning a pregnancy

4. Presence of any abnormality or significant illness that could be expected to interfere with the study.