Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

Phase 4

Completed

• Conditions: Glaucoma
• Interventions: Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

• Registration Number: NCT00966576
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-26
• Study First Submitted QC: 2009-08-26
• Study First Posted: 2009-08-27
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2012-04
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

• Sign Informed Consent.
• 21 years of age or older.
• Able to follow instructions and willing to attend required study visits.
• Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
• Intra-ocular pressure (IOP) considered to be safe in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the trial.
• Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• Presence of other primary or secondary glaucomas not listed in inclusion criterion.
• Presence of corneal dystrophies.
• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
• Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1.
• Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
• Women of childbearing potential not using reliable means of birth control.
• Women who are pregnant or lactating.
• Participation in any other investigational study within 30 days prior to Visit 1.
• Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
• Severe allergic rhinitis
• History of ocular herpes simplex.
• 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
Brinzolamide/Timolol Maleate Fixed Combination	Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)	-

Primary Outcome Measures

Name	Time	Method
The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline	12 weeks

Secondary Outcome Measures

Name	Time	Method
Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success	Week 4 and Week 12