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

Alcon

Status and phase

Completed

Phase 4

Conditions

Open-angle Glaucoma

Glaucoma

Ocular Hypertension

Treatments

Drug: Brinzolamide 1% / timolol 0.5% maleate fixed combination

Study type

Interventional

Funder types

Industry

Identifiers

NCT01415401

RDG-11-199

Details and patient eligibility

About

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).

Enrollment

57 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.