Safety and Efficacy Study of DE-104 Ophthalmic Solution to Treat Open-angle Glaucoma or Ocular Hypertension
NCT ID: NCT00650338
Last Updated: 2011-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
165 participants
INTERVENTIONAL
2008-03-31
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
\<described in intervention\>
DE-104 ophthalmic solution, low concentration
Topical ocular application
2
\<described in intervention\>
DE-104 ophthalmic solution, medium concentration
Topical ocular application
3
\<described in intervention\>
DE-104 ophthalmic solution, high concentration
Topical ocular application
4
\<described in intervention\>
Placebo
placebo
5
\<described intervention\>
0.005% latanoprost
Topical ocular application
Interventions
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DE-104 ophthalmic solution, low concentration
Topical ocular application
DE-104 ophthalmic solution, medium concentration
Topical ocular application
DE-104 ophthalmic solution, high concentration
Topical ocular application
Placebo
placebo
0.005% latanoprost
Topical ocular application
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Presence of any abnormality or significant illness that could be expected to interfere with the study.
18 Years
ALL
No
Sponsors
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Santen Inc.
INDUSTRY
Responsible Party
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Locations
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Sall Research Medical Center
Artesia, California, United States
USC Department of Ophthalmology
Los Angeles, California, United States
Wolstan Eye Associates
Torrance, California, United States
East Florida Eye Institute
Stuart, Florida, United States
Seidenberg Protzko Eye Associates
Bel Air, Maryland, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Rochester Ophthalmological Group, PC
Rochester, New York, United States
Cornerstone Eye Care
High Point, North Carolina, United States
Associated Glaucoma Consultants
Philadelphia, Pennsylvania, United States
Keystone Research, Ltd.
Austin, Texas, United States
David Shulman, MD P-A
San Antonio, Texas, United States
Eye Clinics of South Texas
San Antonio, Texas, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, United States
Virginia Eye Consultants
Norfolk, Virginia, United States
Countries
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Other Identifiers
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27-002
Identifier Type: -
Identifier Source: org_study_id