Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil

• Status: Terminated
• Trial end date: 2012-08-01
• 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 COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.

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

Details

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

Criteria

Inclusion Criteria:

• 18 years of age or older.

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

• Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.

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

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

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

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Presence of other primary or secondary glaucoma not listed in inclusion criteria #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 three 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.

• Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.

• Pregnant or lactating.

• Other protocol-defined exclusion criteria may apply.