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OpenTrials
Completed

NCT Number: NCT01518244

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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.

Treatment and study plan

Brinzolamide/timolol maleate fixed combination

Drug

Other names: AZARGA®

Primary outcomes

  1. Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8

    Time frame: 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 outcomes

  1. Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2012
Registry last updated
Aug 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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