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ELAZOP Switching Study in Korea

Primary Purpose

Open Angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Elazop (Azarga)
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Open angle glaucoma, OAG, Elazop, Azarga, Brinzolamide/Timolol combination

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Seoul National University Bundang Hospital
  • Youngnam Univ. Hospital
  • Seoul National University Hospital
  • Yonsei University Severance Hospital
  • Samsung Medical Center
  • Yonsei University Kangnam Severance Hospital
  • Seoul St. Mary's Hospital, The Catholic University of Korea
  • Asan Medical Center
  • Kim's Eye Hospital
  • St. Mary's Hospital, The Catholic University of Korea

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Elazop (Azarga)

Arm Description

Elazop Treatment arm

Outcomes

Primary Outcome Measures

Mean Intraocular Pressure (IOP) change from baseline at final visit.

Secondary Outcome Measures

Full Information

First Posted
January 22, 2010
Last Updated
December 13, 2012
Sponsor
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT01055366
Brief Title
ELAZOP Switching Study in Korea
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
Open angle glaucoma, OAG, Elazop, Azarga, Brinzolamide/Timolol combination

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elazop (Azarga)
Arm Type
Experimental
Arm Description
Elazop Treatment arm
Intervention Type
Drug
Intervention Name(s)
Elazop (Azarga)
Intervention Description
Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks
Primary Outcome Measure Information:
Title
Mean Intraocular Pressure (IOP) change from baseline at final visit.
Time Frame
12 weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Sungnam
State/Province
Gyounggi
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Youngnam Univ. Hospital
City
Daegu
ZIP/Postal Code
705-707
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Yonsei University Kangnam Severance Hospital
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Seoul St. Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
137-040
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-706
Country
Korea, Republic of
Facility Name
Kim's Eye Hospital
City
Seoul
ZIP/Postal Code
150-034
Country
Korea, Republic of
Facility Name
St. Mary's Hospital, The Catholic University of Korea
City
Seoul
ZIP/Postal Code
150-703
Country
Korea, Republic of

12. IPD Sharing Statement

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ELAZOP Switching Study in Korea

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