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

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 Brazil

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.

Study Overview

• Status: Terminated
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Brinzolamide/timolol maleate fixed combination

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil, 11045-140
    • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AZARGA; Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks	Drug: Brinzolamide/timolol maleate fixed combination; Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.; Other Names: AZARGA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).	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).	8 weeks

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Doug Hubatsch, M.Sc., Alcon Research

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): August 1, 2012
• Study Completion (ACTUAL): August 1, 2012

Study Registration Dates

• First Submitted: January 18, 2012
• First Submitted That Met QC Criteria: January 18, 2012
• First Posted (ESTIMATE): January 23, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): October 21, 2013
• Last Update Submitted That Met QC Criteria: August 15, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Ocular hypertension; Primary open-angle glaucoma; Pigment dispersion glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Antihypertensive Agents; Enzyme Inhibitors; Carbonic Anhydrase Inhibitors; Timolol; Brinzolamide
• Other Study ID Numbers: RDG-11-191