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Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

Primary Purpose

Glaucoma, Ocular Hypertension, Open-angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brinzolamide 1% / timolol 0.5% maleate fixed combination
Sponsored by
Alcon Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Ocular hypertension, Intraocular pressure (IOP), Open angle glaucoma, Pigment dispersion glaucoma, Pigmentary

Eligibility Criteria

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

Inclusion Criteria:

  • Willing to sign an Informed Consent form.
  • Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
  • Be on a stable IOP lowering regimen within 30 days of Screening Visit.
  • 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 study period.
  • Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.
  • IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
  • Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.
  • Willing to follow instructions and able to attend required study visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known history of hypersensitivity to any component of the preparations used in this study.
  • Presence of primary or secondary glaucoma not listed in inclusion criterion #2.
  • History of ocular herpes simplex.
  • Abnormality preventing reliable applanation tonometry.
  • Corneal dystrophies.
  • Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
  • Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to the Screening Visit.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
  • Progressive retinal or optic nerve disease from any cause.
  • Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit.
  • Pregnant or lactating.
  • Other protocol-defined exclusion criteria may apply.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    AZARGA

    Arm Description

    Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)

    Outcomes

    Primary Outcome Measures

    Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)
    IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

    Secondary Outcome Measures

    Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)
    IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

    Full Information

    First Posted
    August 10, 2011
    Last Updated
    May 30, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01415401
    Brief Title
    Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada
    Official Title
    Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Canada
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2011 (undefined)
    Primary Completion Date
    June 2013 (Actual)
    Study Completion Date
    June 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 assess the efficacy and tolerability of changing to AZARGA® from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Hypertension, Open-angle Glaucoma
    Keywords
    Glaucoma, Ocular hypertension, Intraocular pressure (IOP), Open angle glaucoma, Pigment dispersion glaucoma, Pigmentary

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    57 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    AZARGA
    Arm Type
    Experimental
    Arm Description
    Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide 1% / timolol 0.5% maleate fixed combination
    Other Intervention Name(s)
    AZARGA®
    Primary Outcome Measure Information:
    Title
    Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)
    Description
    IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
    Time Frame
    Baseline, Week 8
    Secondary Outcome Measure Information:
    Title
    Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)
    Description
    IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in mmHg. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
    Time Frame
    Week 8

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Willing to sign an Informed Consent form. Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye). Be on a stable IOP lowering regimen within 30 days of Screening Visit. 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 study period. Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1. IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy. Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye. Willing to follow instructions and able to attend required study visits. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known history of hypersensitivity to any component of the preparations used in this study. Presence of primary or secondary glaucoma not listed in inclusion criterion #2. History of ocular herpes simplex. Abnormality preventing reliable applanation tonometry. Corneal dystrophies. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed. Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to the Screening Visit. Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment. Progressive retinal or optic nerve disease from any cause. Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit. Pregnant or lactating. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Danyel C. Carr, MS, CCRA
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

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