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Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brinzolamide 1% / timolol 0.5% Fixed Combination
Habitual prostaglandin monotherapy
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 AZARGA®, Open angle glaucoma, Prostaglandin Therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Clinical diagnosis of ocular hypertension, primary open angle (including pigment dispersion) glaucoma in both eyes.
  • 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.
  • Treated with, and in the Investigator's judgment demonstrated an inadequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit 1. Last dose of prostaglandin instilled correctly to put patient within the dosing cycle at Visit 1.
  • At Visit 1, have an IOP of ≥ 20 mmHg in at least one eye and ≤ 35 mmHg in both eyes treated with prostaglandin monotherapy.
  • Best corrected visual acuity of 1.0 LogMAR or better in each eye.
  • In any eye not qualifying as a study eye, IOP should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
  • Willing to sign an informed consent form.
  • Able to follow instructions and willing and able to attend required study visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known medical history of allergy, hypersensitivity or poor tolerance to any component of AZARGA® that is deemed clinically significant in the opinion of the investigator.
  • A history of, or at risk for uveitis or cystoid macular edema (CME).
  • History of ocular herpes simplex.
  • Corneal dystrophies in either eye.
  • Concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye (excluding Blepharitis or non-clinically significant conjunctival hyperemia).
  • Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to Visit 1.
  • 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 apart from glaucoma.
  • Use of systemic medications known to affect IOP (e.g. oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Visit 1 or an anticipated change in the dosage during the course of the study.
  • Use of corticosteroids (oral, topical ocular or nasal) within 30 days of Visit 1 and during the course of the study.
  • Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
  • History of severe allergic rhinitis.
  • A condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
  • Use of any systemic carbonic anhydrase inhibitors (CAI) (e.g. methazolamide [Neptazane], acetazolamide [Diamox]).
  • Severely impared renal function.
  • History of an allergy to sulphonamides.
  • Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, severe allergic rhinitis or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
  • Pregnant, lactating, or of childbearing potential and not using a reliable method of birth control.
  • Any clinically significant, serious, or severe medical condition.
  • Participation in any other investigational study within 30 days prior to the screening/baseline visit.
  • 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% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.

    Outcomes

    Primary Outcome Measures

    Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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. Only one eye (study eye) contributed to the mean.

    Secondary Outcome Measures

    Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.
    Mean Change From Baseline in IOP at Week 4
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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. Only one eye (study eye) contributed to the mean.
    Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.

    Full Information

    First Posted
    December 17, 2010
    Last Updated
    May 18, 2014
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01263444
    Brief Title
    Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy
    Official Title
    Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (AZARGA®) to Ocular Hypertensive or Glaucoma Patients Uncontrolled on Prostaglandin Monotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2011 (undefined)
    Primary Completion Date
    April 2013 (Actual)
    Study Completion Date
    April 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 adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.
    Detailed Description
    This study consisted of 3 study visits (Screening/Baseline, Week 4, and Week 12). Eligible patients self-administered the study medication (AZARGA® Eye Drops), adjunct to their current prostaglandin monotherapy for 3 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Hypertension
    Keywords
    AZARGA®, Open angle glaucoma, Prostaglandin Therapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Azarga
    Arm Type
    Experimental
    Arm Description
    Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
    Intervention Type
    Drug
    Intervention Name(s)
    Brinzolamide 1% / timolol 0.5% Fixed Combination
    Other Intervention Name(s)
    AZARGA®
    Intervention Type
    Drug
    Intervention Name(s)
    Habitual prostaglandin monotherapy
    Other Intervention Name(s)
    Latanoprost, Travoprost, Bimatoprost, Tafluprost
    Intervention Description
    Topical ocular therapy used daily as prescribed
    Primary Outcome Measure Information:
    Title
    Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
    Description
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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. Only one eye (study eye) contributed to the mean.
    Time Frame
    Baseline, Week 12
    Secondary Outcome Measure Information:
    Title
    Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
    Description
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.
    Time Frame
    Baseline, Week 12
    Title
    Mean Change From Baseline in IOP at Week 4
    Description
    IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. 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. Only one eye (study eye) contributed to the mean.
    Time Frame
    Baseline, Week 4
    Title
    Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)
    Description
    IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.
    Time Frame
    Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Clinical diagnosis of ocular hypertension, primary open angle (including pigment dispersion) glaucoma in both eyes. 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. Treated with, and in the Investigator's judgment demonstrated an inadequate response to, prostaglandin monotherapy for a minimum of 4 weeks at Visit 1. Last dose of prostaglandin instilled correctly to put patient within the dosing cycle at Visit 1. At Visit 1, have an IOP of ≥ 20 mmHg in at least one eye and ≤ 35 mmHg in both eyes treated with prostaglandin monotherapy. Best corrected visual acuity of 1.0 LogMAR or better in each eye. In any eye not qualifying as a study eye, IOP should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone. Willing to sign an informed consent form. Able to follow instructions and willing and able to attend required study visits. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Known medical history of allergy, hypersensitivity or poor tolerance to any component of AZARGA® that is deemed clinically significant in the opinion of the investigator. A history of, or at risk for uveitis or cystoid macular edema (CME). History of ocular herpes simplex. Corneal dystrophies in either eye. Concurrent infectious/non infectious conjunctivitis, keratitis or uveitis in either eye (excluding Blepharitis or non-clinically significant conjunctival hyperemia). Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to Visit 1. 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 apart from glaucoma. Use of systemic medications known to affect IOP (e.g. oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for 7 days prior to Visit 1 or an anticipated change in the dosage during the course of the study. Use of corticosteroids (oral, topical ocular or nasal) within 30 days of Visit 1 and during the course of the study. Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. History of severe allergic rhinitis. A condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject. Use of any systemic carbonic anhydrase inhibitors (CAI) (e.g. methazolamide [Neptazane], acetazolamide [Diamox]). Severely impared renal function. History of an allergy to sulphonamides. Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, severe allergic rhinitis or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker. Pregnant, lactating, or of childbearing potential and not using a reliable method of birth control. Any clinically significant, serious, or severe medical condition. Participation in any other investigational study within 30 days prior to the screening/baseline visit. Other protocol-defined exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Severine Durier, Pharm. D
    Organizational Affiliation
    Alcon Research
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy

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