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Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Brinzolamide 1% ophthalmic suspension
Brimonidine tartrate 0.2% ophthalmic solution
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-Angle Glaucoma focused on measuring Open-Angle glaucoma, Ocular Hypertension, OAG, OHT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosed with open angle glaucoma or ocular hypertension, and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
  • Meet qualifying IOP entry criteria.
  • Able to understand and sign an informed consent form.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Women of childbearing potential if pregnant, test positive for pregnancy at Screening Visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
  • Severe central visual field loss.
  • Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
  • Chronic, recurrent or severe inflammatory eye disease.
  • Ocular trauma within the preceding 6 months.
  • Ocular infection or ocular inflammation within the preceding 3 months.
  • Clinically significant or progressive retinal disease.
  • Other ocular pathology.
  • Intraocular surgery within the 6 months prior to entry.
  • Ocular laser surgery within the 3 months prior to entry.
  • Any abnormality preventing reliable applanation tonometry.
  • Any other conditions, including severe illness, which would make the subject, in the opinion of the Investigator, unsuitable for the study.
  • Recent use of high-dose (>1 gram daily) salicylate therapy.
  • Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.
  • Concurrent use of glucocorticoid medications administered by any route.
  • Other protocol-specified exclusion crtieria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    Brinz/Brim

    Brinz

    Brim

    Arm Description

    Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months

    Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months

    Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months

    Outcomes

    Primary Outcome Measures

    Mean Diurnal IOP Change From Baseline at Month 3
    Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

    Secondary Outcome Measures

    Full Information

    First Posted
    March 7, 2011
    Last Updated
    January 24, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01310777
    Brief Title
    Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
    Official Title
    Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Fixed Combination Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension and Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2013
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2011 (undefined)
    Primary Completion Date
    January 2013 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Alcon Research

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma or ocular hypertension.
    Detailed Description
    This study consisted of 7 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements within the specified range during this period were randomized to 1 of 3 study drug groups: Brinz/Brim, Brinz, or Brim.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Open-Angle Glaucoma, Ocular Hypertension
    Keywords
    Open-Angle glaucoma, Ocular Hypertension, OAG, OHT

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    771 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brinz/Brim
    Arm Type
    Experimental
    Arm Description
    Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
    Arm Title
    Brinz
    Arm Type
    Active Comparator
    Arm Description
    Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
    Arm Title
    Brim
    Arm Type
    Active Comparator
    Arm Description
    Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide 1% ophthalmic suspension
    Other Intervention Name(s)
    AZOPT™
    Intervention Type
    Drug
    Intervention Name(s)
    Brimonidine tartrate 0.2% ophthalmic solution
    Primary Outcome Measure Information:
    Title
    Mean Diurnal IOP Change From Baseline at Month 3
    Description
    Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM, + 2 h, and + 7 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
    Time Frame
    Baseline (Day 1), Month 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosed with open angle glaucoma or ocular hypertension, and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications. Meet qualifying IOP entry criteria. Able to understand and sign an informed consent form. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Women of childbearing potential if pregnant, test positive for pregnancy at Screening Visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. Severe central visual field loss. Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent). Chronic, recurrent or severe inflammatory eye disease. Ocular trauma within the preceding 6 months. Ocular infection or ocular inflammation within the preceding 3 months. Clinically significant or progressive retinal disease. Other ocular pathology. Intraocular surgery within the 6 months prior to entry. Ocular laser surgery within the 3 months prior to entry. Any abnormality preventing reliable applanation tonometry. Any other conditions, including severe illness, which would make the subject, in the opinion of the Investigator, unsuitable for the study. Recent use of high-dose (>1 gram daily) salicylate therapy. Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist. Concurrent use of glucocorticoid medications administered by any route. Other protocol-specified exclusion crtieria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James Teague, Sr. Clinical Manager
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

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