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

Phase 4

Completed

• Conditions: Glaucoma; Ocular Hypertension; Open-angle Glaucoma
• Interventions: Drug: Brinzolamide 1% / timolol 0.5% maleate fixed combination

• Registration Number: NCT01415401
• Lead Sponsor: Alcon Research

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-12
• Study Start: 2011-09
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-05
• Results First Submitted: 2014-05-30
• Results First Submitted QC: 2014-05-30
• Last Update Submitted: 2014-05-30
• Results First Posted: 2014-07-01
• Last Update Posted: 2014-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)	Baseline, Week 8	IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). 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)	Week 8	IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. 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.