AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops

• Registration Number: NCT01484951
• Lead Sponsor: Alcon Research

Brief Summary

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.

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 Start: 2011-05
• Study First Submitted: 2011-12-01
• Study First Submitted QC: 2011-12-01
• Study First Posted: 2011-12-05
• Primary Completion: 2012-03
• Study Completion: 2012-03
• Results First Submitted: 2013-03-12
• Results First Submitted QC: 2013-03-12
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-25
• Results First Posted: 2013-04-26
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AZARGA	Brinzolamide 1% and timolol 0.5% fixed combination eye drops	Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.

Primary Outcome Measures

Name	Time	Method
Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)	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 Outcome Measures

Name	Time	Method
Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy	Week 8	As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States