ELAZOP Switching Study in Korea

Sponsor

Alcon Research (Industry)

Overall Status

Completed

CT.gov ID

NCT01055366

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

9.6

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Open Angle Glaucoma	Drug: Elazop (Azarga)	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

96 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Elazop (Azarga) Elazop Treatment arm	Drug: Elazop (Azarga) Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks

Arm

Intervention/Treatment

Experimental: Elazop (Azarga)

Elazop Treatment arm

Drug: Elazop (Azarga)

Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks

Outcome Measures

Primary Outcome Measures

Mean Intraocular Pressure (IOP) change from baseline at final visit. [12 weeks after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Sungnam	Gyounggi	Korea, Republic of	463-707
2	Youngnam Univ. Hospital	Daegu		Korea, Republic of	705-707
3	Seoul National University Hospital	Seoul		Korea, Republic of	110-744
4	Yonsei University Severance Hospital	Seoul		Korea, Republic of	120-752
5	Samsung Medical Center	Seoul		Korea, Republic of	135-710
6	Yonsei University Kangnam Severance Hospital	Seoul		Korea, Republic of	135-720
7	Seoul St. Mary's Hospital, The Catholic University of Korea	Seoul		Korea, Republic of	137-040
8	Asan Medical Center	Seoul		Korea, Republic of	138-706
9	Kim's Eye Hospital	Seoul		Korea, Republic of	150-034
10	St. Mary's Hospital, The Catholic University of Korea	Seoul		Korea, Republic of	150-703