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

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Brinzolamide/timolol maleate fixed combination

• Registration Number: NCT01518244
• Lead Sponsor: Alcon Research

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-23
• Study First Posted: 2012-01-25
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2014-02
• Results First Submitted: 2014-02-25
• Results First Submitted QC: 2014-02-25
• Results First Posted: 2014-04-04
• Last Update Submitted: 2015-07-17
• Last Update Posted: 2015-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZARGA®	Brinzolamide/timolol maleate fixed combination	Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8	Baseline, Week 8	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8	Week 8	IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.