ELAZOP Switching Study in Korea

Alcon

Status and phase

Completed

Phase 4

Conditions

Open Angle Glaucoma

Treatments

Drug: Elazop (Azarga)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01055366

RM-09-06

Details and patient eligibility

About

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.

Enrollment

96 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.