ELAZOP Switching Study in Korea

Phase 4

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Drug: Elazop (Azarga)

• Registration Number: NCT01055366
• Lead Sponsor: Alcon Research

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-01-22
• Study First Submitted QC: 2010-01-22
• Study First Posted: 2010-01-25
• Study Start: 2010-03
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-05
• Last Update Submitted: 2012-12-13
• Last Update Posted: 2012-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Elazop (Azarga)	Elazop (Azarga)	Elazop Treatment arm

Primary Outcome Measures

Name	Time	Method
Mean Intraocular Pressure (IOP) change from baseline at final visit.	12 weeks after treatment

Trial Locations

Locations (10)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Sungnam, Gyounggi, Korea, Republic of

Youngnam Univ. Hospital; 🇰🇷 Daegu, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Kangnam Severance Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of

St. Mary's Hospital, The Catholic University of Korea; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kim's Eye Hospital; 🇰🇷 Seoul, Korea, Republic of

Yonsei University Severance Hospital; 🇰🇷 Seoul, Korea, Republic of