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 |
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.
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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