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



Status:Completed
Conditions:High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:10/14/2017
Start Date:March 2009
End Date:June 2010

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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

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.


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
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