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

Alcon

Status and phase

Completed

Phase 4

Conditions

Glaucoma

Treatments

Drug: Brinzolamide/timolol maleate fixed combination

Study type

Interventional

Funder types

Industry

Identifiers

NCT01518244

RDG-11-198

Details and patient eligibility

About

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
IOP considered safe in both eyes in order to 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.
History of ocular herpes simplex.
Any 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 Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
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 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.