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

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Glaucoma and Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT01654484

Run by

Santen Inc.

People needed

60

Starts

2012-07-01

Expected to finish

2012-11-01

Last updated by the study team

2018-04-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or Female, 18 years of age or older
• Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
• Qualifying intraocular pressure (IOP) in at least one eye at Baseline

You may not qualify if…

• Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
• Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
• Females who are pregnant, nursing or planning a pregnancy
• Presence of any abnormality or significant illness that could be expected to interfere with the study.

Where it is running

• Santen Investigational Site — Newport Beach, California, United States
• Santen Investigational Site — Deerfield Beach, Florida, United States
• Santen Investigational Site — Largo, Florida, United States
• Santen Investigational Site — Morrow, Georgia, United States
• Santen Investigational Site — Roswell, Georgia, United States
• Santen Investigational Site — Rochester, New York, United States
• Santen Investigational Site — Cleveland, Ohio, United States
• Santen Investigational Site — Austin, Texas, United States
• Santen Investigational Site — Fort Worth, Texas, United States
• Santen Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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