Overview

ELAZOP Switching Study in Korea

Status:
Completed
Trial end date:
2011-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Alcon Research
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.