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

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

Conditions studied: Open-Angle Glaucoma, Ocular Hypertension

In brief

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.

Key facts

Study ID

NCT00868894

Run by

Santen Inc.

People needed

49

Starts

2009-03-01

Expected to finish

2010-06-01

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.
• 18 years of age and older.
• Diagnosed with primary open-angle glaucoma or ocular hypertension.
• 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

• Study site — Artesia, California, United States
• Study site — Pasadena, California, United States
• Study site — San Francisco, California, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Kailua, Hawaii, United States
• Study site — New York, New York, United States

Full record on ClinicalTrials.gov

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