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Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

Primary Purpose

Open-Angle Glaucoma, Ocular Hypertension

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Brinzolamide ophthalmic suspension, 1%
Brimonidine tartrate ophthalmic solution, 0.2%
Vehicle
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, Brinzolamide, Brimonidine, Intraocular Pressure

Eligibility Criteria

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

Inclusion Criteria:

  • Sign Informed Consent document.
  • Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
  • Any form of glaucoma other than open-angle glaucoma.
  • Severe central vision loss in either eye.
  • 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 such as retinal degeneration, diabetic retinopathy, or retinal detachment.
  • Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
  • Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
  • Ocular surgery within the preceding 6 months.
  • Ocular laser surgery within the preceding 3 months.
  • Any abnormality preventing reliable applanation tonometry.
  • Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study.
  • Other protocol-specified exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Brinz/Brim

    Brinz

    Brim

    Brinz+Brim

    Arm Description

    Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

    Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

    Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

    Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

    Outcomes

    Primary Outcome Measures

    Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim
    The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).
    Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim
    The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.

    Secondary Outcome Measures

    Full Information

    First Posted
    August 18, 2009
    Last Updated
    May 17, 2013
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00961649
    Brief Title
    Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination
    Official Title
    Safety and IOP-Lowering Efficacy of Brinzolamide/Brimonidine Fixed Combination Ophthalmic Suspension in Patients With Open-Angle Glaucoma and/or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2013
    Overall Recruitment Status
    Terminated
    Study Start Date
    October 2009 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    February 2010 (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 compare the safety and intraocular pressure (IOP)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to: its individual components (Brinz and Brim), and the concomitant administration of Brinz and Brim (Brinz+Brim).
    Detailed Description
    This study consisted of 5 visits conducted during 2 sequential phases: the screening/eligibility phase, which included a screening visit and 2 eligibility visits, and the treatment phase, which included 2 on-therapy visits conducted at Week 2 and Week 6 (or early exit). A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 4 study drug groups for 6 weeks. Study drug instillation began the morning after the second eligibility visit. The study was terminated by the sponsor out of caution due to microgel formation in the Brinz/Brim formulation. 13 remaining active subjects were discontinued. Further analysis revealed that neither the drop size nor the concentration of the active ingredients was affected.

    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, Brinzolamide, Brimonidine, Intraocular Pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    195 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brinz/Brim
    Arm Type
    Experimental
    Arm Description
    Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.
    Arm Title
    Brinz
    Arm Type
    Active Comparator
    Arm Description
    Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.
    Arm Title
    Brim
    Arm Type
    Active Comparator
    Arm Description
    Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.
    Arm Title
    Brinz+Brim
    Arm Type
    Active Comparator
    Arm Description
    Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide ophthalmic suspension, 1%
    Intervention Type
    Drug
    Intervention Name(s)
    Brimonidine tartrate ophthalmic solution, 0.2%
    Intervention Type
    Other
    Intervention Name(s)
    Vehicle
    Intervention Description
    Inactive ingredients used as placebo
    Primary Outcome Measure Information:
    Title
    Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim
    Description
    The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).
    Time Frame
    Baseline, Week 6
    Title
    Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim
    Description
    The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.
    Time Frame
    Baseline, Week 6

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Sign Informed Consent document. Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s. Other protocol-specified inclusion criteria may apply. Exclusion Criteria: Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures. Any form of glaucoma other than open-angle glaucoma. Severe central vision loss in either eye. 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 such as retinal degeneration, diabetic retinopathy, or retinal detachment. Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart. Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product. Ocular surgery within the preceding 6 months. Ocular laser surgery within the preceding 3 months. Any abnormality preventing reliable applanation tonometry. Any other conditions, including severe illness, which could make the patient, in the opinion of the Investigator, unsuitable for the study. Other protocol-specified exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    James Teague, BS, Sr. Clinical Manager
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

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