ELAZOP Switching Study in Korea
1 other identifier
interventional
96
1 country
10
Brief Summary
The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2010
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 25, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedDecember 17, 2012
May 1, 2012
1.8 years
January 22, 2010
December 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Intraocular Pressure (IOP) change from baseline at final visit.
12 weeks after treatment
Study Arms (1)
Elazop (Azarga)
EXPERIMENTALElazop Treatment arm
Interventions
Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks
Eligibility Criteria
You may qualify if:
- years of age or older.
- 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.
You may not qualify if:
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in the study that is deemed clinically significant in the opinion of the Principal Investigator.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (10)
Youngnam Univ. Hospital
Daegu, Daegu, 705-707, South Korea
Seoul National University Bundang Hospital
Sungnam, Gyounggi, 463-707, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Yonsei University Severance Hospital
Seoul, 120-752, South Korea
Samsung Medical Center
Seoul, 135-710, South Korea
Yonsei University Kangnam Severance Hospital
Seoul, 135-720, South Korea
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 137-040, South Korea
Asan Medical Center
Seoul, 138-706, South Korea
Kim's Eye Hospital
Seoul, 150-034, South Korea
St. Mary's Hospital, The Catholic University of Korea
Seoul, 150-703, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 25, 2010
Study Start
March 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
December 17, 2012
Record last verified: 2012-05