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

Completed · Phase 2 · Has a placebo group

Conditions studied: Open-Angle Glaucoma, Ocular Hypertension

In brief

To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) in subjects with Primary Open-Angle Glaucoma or Ocular Hypertension

Key facts

Study ID

NCT00650338

Run by

Santen Inc.

People needed

165

Starts

2008-03-01

Expected to finish

2008-10-01

Last updated by the study team

2011-11-03

Who can join

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

You may qualify if…

• Provided signed, written informed consent.
• Diagnosed with primary open-angle glaucoma or ocular hypertension.
• 18 years of age and older.
• If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.

You may not qualify if…

• Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
• Presence of any abnormality or significant illness that could be expected to interfere with the study.

Where it is running

• Sall Research Medical Center — Artesia, California, United States
• USC Department of Ophthalmology — Los Angeles, California, United States
• Wolstan Eye Associates — Torrance, California, United States
• East Florida Eye Institute — Stuart, Florida, United States
• Seidenberg Protzko Eye Associates — Bel Air, Maryland, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Rochester Ophthalmological Group, PC — Rochester, New York, United States
• Cornerstone Eye Care — High Point, North Carolina, United States
• Associated Glaucoma Consultants — Philadelphia, Pennsylvania, United States
• Keystone Research, Ltd. — Austin, Texas, United States
• David Shulman, MD P-A — San Antonio, Texas, United States
• Eye Clinics of South Texas — San Antonio, Texas, United States
• Medical Center Ophthalmology Associates — San Antonio, Texas, United States
• Virginia Eye Consultants — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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