A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

Phase 2

Completed

• Conditions: Open-Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Brimonidine tartrate ophthalmic solution, 0.2%; Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Drug: Brinzolamide ophthalmic suspension, 1%

• Registration Number: NCT01426867
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study was to describe the ocular discomfort immediately upon instillation of Brinzolamide 1%/Brimonidine 0.2% Tartrate Ophthalmic Suspension, Brinzolamide 1% Ophthalmic Suspension, and Brimonidine Tartrate 0.2% Ophthalmic Solution in subjects with open-angle glaucoma and/or ocular hypertension.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-08-24
• Study First Submitted QC: 2011-08-30
• Study Start: 2011-09
• Study First Posted: 2011-09-01
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Disposition First Submitted: 2012-07-17
• Disposition First Submitted QC: 2012-07-17
• Disposition First Posted: 2012-07-25
• Status Verified: 2013-05
• Results First Submitted: 2013-05-17
• Results First Submitted QC: 2013-05-17
• Last Update Submitted: 2013-05-17
• Results First Posted: 2013-07-08
• Last Update Posted: 2013-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Sign Informed Consent document.
• Diagnosis of open-angle glaucoma or ocular hypertension
• Other protocol-specified inclusion criteria may apply.

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Exclusion Criteria

• Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
• Severe central vision loss in either eye.
• Any chronic or recurrent inflammatory eye disease.
• Ocular trauma within the preceding 6 months.
• Ocular infection or ocular inflammation within the preceding 3 months.
• Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
• Any intraocular surgery within the preceding 6 months.
• Any ocular laser surgery within the preceding 3 months.
• History or current evidence of severe illness or any other conditions which would make the subject, in the opinion of the Investigator, unsuitable for the study.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Brimonidine	Brimonidine tartrate ophthalmic solution, 0.2%	Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
Brinz/Brim	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension	Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
Brinzolamide	Brinzolamide ophthalmic suspension, 1%	Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days

Primary Outcome Measures

Name	Time	Method
Mean Ocular Discomfort Score	Week 1	Ocular discomfort was assessed by the subject immediately following the 8 AM instillation of study drug and rated on a 5-point scale: 0 (none), 1 (mild), 2 (moderate), 3 (severe), and 4 (very severe).