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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

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ClinicalTrials.gov Identifier: NCT01514734
Recruitment Status : Terminated (Low recruitment rate)
First Posted : January 23, 2012
Results First Posted : October 21, 2013
Last Update Posted : October 21, 2013
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Brinzolamide/timolol maleate fixed combination Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2012
Primary Completion Date : August 2012
Study Completion Date : August 2012

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 Name: AZARGA®

Primary Outcome Measures :
  1. Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy). [ Time Frame: 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).

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01514734

Contact Alcon Call Center for Trial Locations
São Paulo, Brazil, 11045-140
Sponsors and Collaborators
Alcon Research
Study Director: Doug Hubatsch, M.Sc. Alcon Research

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01514734     History of Changes
Other Study ID Numbers: RDG-11-191
First Posted: January 23, 2012    Key Record Dates
Results First Posted: October 21, 2013
Last Update Posted: October 21, 2013
Last Verified: August 2013

Keywords provided by Alcon Research:
Primary open-angle glaucoma
Ocular hypertension
Pigment dispersion glaucoma

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Brimonidine Tartrate, Timolol Maleate Drug Combination
Brimonidine Tartrate
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Carbonic Anhydrase Inhibitors