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

NCT ID: NCT01415401

Last Updated: 2014-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2013-06-30

Brief 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).

Conditions

Glaucoma; Ocular Hypertension; Open-angle Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

AZARGA

Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)

Group Type: EXPERIMENTAL

Brinzolamide 1% / timolol 0.5% maleate fixed combination

Intervention Type: DRUG

Interventions

Brinzolamide 1% / timolol 0.5% maleate fixed combination

Intervention Type: DRUG

Other Intervention Names

AZARGA®

Eligibility 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Danyel C. Carr, MS, CCRA

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

RDG-11-199

Identifier Type: -

Identifier Source: org_study_id