Status:
COMPLETED
Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Santen Inc.
Conditions:
Open-Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 hyperten...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00868894
Start Date
March 1 2009
End Date
June 1 2010
Last Update
November 3 2011
Active Locations (6)
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1
Artesia, California, United States, 90701
2
Pasadena, California, United States, 91105
3
San Francisco, California, United States, 94102
4
Honolulu, Hawaii, United States, 96814