ELAZOP Switching Study in Korea
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open Angle Glaucoma
Intervention: Elazop (Azarga) (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research
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.
Clinical Details
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Intraocular Pressure (IOP) change from baseline at final visit.
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 18 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.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- 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.
- Other protocol-defined exclusion criteria may apply.
Locations and Contacts
Youngnam Univ. Hospital, Daegu 705-707, Korea, Republic of
Asan Medical Center, Seoul 138-706, Korea, Republic of
Kim's Eye Hospital, Seoul 150-034, Korea, Republic of
Samsung Medical Center, Seoul 135-710, Korea, Republic of
Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul 137-040, Korea, Republic of
St. Mary's Hospital, The Catholic University of Korea, Seoul 150-703, Korea, Republic of
Yonsei University Kangnam Severance Hospital, Seoul 135-720, Korea, Republic of
Yonsei University Severance Hospital, Seoul 120-752, Korea, Republic of
Seoul National University Bundang Hospital, Sungnam, Gyounggi 463-707, Korea, Republic of
Additional Information
Starting date: March 2010
Last updated: December 13, 2012
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