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:
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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.
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 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
165 Patients enrolled
Trial Details
Trial ID
NCT00650338
Start Date
March 1 2008
End Date
October 1 2008
Last Update
November 3 2011
Active Locations (14)
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1
Sall Research Medical Center
Artesia, California, United States, 90701
2
USC Department of Ophthalmology
Los Angeles, California, United States, 90033
3
Wolstan Eye Associates
Torrance, California, United States, 90505
4
East Florida Eye Institute
Stuart, Florida, United States, 34994