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

Phase 4

Terminated

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

• Registration Number: NCT01514734
• 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 patients 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
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Trial Locations

Study Timeline

• Study First Submitted: 2012-01-18
• Study First Submitted QC: 2012-01-18
• Study First Posted: 2012-01-23
• Study Start: 2012-03
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2013-08
• Results First Submitted: 2013-08-15
• Results First Submitted QC: 2013-08-15
• Last Update Submitted: 2013-08-15
• Results First Posted: 2013-10-21
• Last Update Posted: 2013-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• 18 years of age or older.
• Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
• Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.
• IOP considered safe in both eyes in such a way that should 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 not listed in inclusion criteria #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 three 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.
• Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the 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, one drop self-administered in study eye(s) twice a day for 8 weeks

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).	8 weeks	Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇧🇷 São Paulo, Brazil