Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Brimonidine Tartrate, Timolol Maleate Drug Combination; Brinzolamide; Maleic acid; Timolol

Criteria

Inclusion Criteria:

• Willing to sign an Informed Consent form.

• Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).

• Be on a stable IOP lowering regimen within 30 days of Screening Visit.

• IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.

• Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.

• IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.

• Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.

• Willing to follow instructions and able to attend required study visits.

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known history of hypersensitivity to any component of the preparations used in this study.

• Presence of primary or secondary glaucoma not listed in inclusion criterion #2.

• History of ocular herpes simplex.

• Abnormality preventing reliable applanation tonometry.

• Corneal dystrophies.

• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.

• Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to the Screening Visit.

• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.

• Progressive retinal or optic nerve disease from any cause.

• Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit.

• Pregnant or lactating.

• Other protocol-defined exclusion criteria may apply.