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Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%

NCT01297920 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1062

Last updated 2013-07-04

Study results available
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Summary

The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/or ocular hypertension.

Conditions

Interventions

DRUG

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

DRUG

Brinzolamide ophthalmic suspension, 1%

DRUG

Brimonidine tartrate ophthalmic solution, 0.2%

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • James Teague, BS, Sr. Clinical Manager · Alcon Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-06-30
Completion
2012-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01297920 on ClinicalTrials.gov