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OpenTrials
Completed

NCT Number: NCT01484951

AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.

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Key information

Conditions

Glaucoma Eye Diseases Glaucoma, Open-Angle Ocular Hypertension

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

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, primary open-angle or pigment dispersion glaucoma in both eyes.
  • Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
  • Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
  • Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
  • Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
  • Any abnormality preventing reliable applanation tonometry in either eye.
  • Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
  • Pregnant or lactating.
  • Participation in any other investigational study within 30 days of screening visit.
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Brinzolamide 1% and timolol 0.5% fixed combination eye drops

Drug

Other names: AZARGA®

Primary outcomes

  1. Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)

    Time frame: Baseline, Week 8

    As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.

Secondary outcomes

  1. Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy

    Time frame: Week 8

    As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

Assessing the Safety and Efficacy of Switching to AZARGA® (Brinzolamide/Timolol Fixed Combination) as Replacement Therapy in Patients With Uncontrolled Intraocular Pressure in Taiwan

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 5, 2011
Registry last updated
May 1, 2013

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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