ELAZOP Switching Study in Korea

Open Angle Glaucoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055366
• Other study ID #: RM-09-06
• Status: Completed
• Phase: Phase 4
• First received: January 22, 2010
• Last updated: December 13, 2012
• Start date: March 2010
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

Drug:
• Elazop (Azarga)
Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks

Locations

Country	Name	City	State
Korea, Republic of	Youngnam Univ. Hospital	Daegu
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kim's Eye Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University 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	Yonsei University Kangnam Severance Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Seoul National University Bundang Hospital	Sungnam	Gyounggi

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Intraocular Pressure (IOP) change from baseline at final visit.		12 weeks after treatment	No