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
PHASE4
96 participants
INTERVENTIONAL
2010-03-31
2011-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Elazop (Azarga)
Elazop Treatment arm
Elazop (Azarga)
Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks
Interventions
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Elazop (Azarga)
Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
* Must be on a stable regimen of Intraocular Pressure (IOP) lowering medication (i.e., either a single therapeutic agent or two separate ocular hypotensive agents) for at least one month prior to the Screening Visit.
* Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
* Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Exclusion Criteria
* Intraocular conventional surgery or laser surgery in either eye less than three months prior to the Screening visit.
* History of ocular herpes simplex.
* Pregnant or lactating.
* Participation in any other investigational study within 30 days of Screening visit.
18 Years
80 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Locations
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Youngnam Univ. Hospital
Daegu, Daegu, South Korea
Seoul National University Bundang Hospital
Sungnam, Gyounggi, South Korea
Seoul National University Hospital
Seoul, , South Korea
Yonsei University Severance Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Yonsei University Kangnam Severance Hospital
Seoul, , South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Kim's Eye Hospital
Seoul, , South Korea
St. Mary's Hospital, The Catholic University of Korea
Seoul, , South Korea
Countries
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Other Identifiers
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RM-09-06
Identifier Type: -
Identifier Source: org_study_id