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Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

Primary Purpose

Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
BETAXON (levobetaxolol HCl)
AZOPT (brinzolamide)
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

Eligibility Criteria

1 Week - 5 Years (Child)All SexesDoes not accept healthy volunteers

INCLUSION: Children 5 years old and younger require treatment for glaucoma or ocular hypertension vision is 20/80 or better cup-to-disc ratio of 0.8 or less EXCLUSION: do not have abnormal fixation IOP greater than 36 mm Hg significant retinal disease penetrating keratoplasty severe ocular pathology optic atrophy eye surgery in the past 30 days cardiovascular abnormalities hypersensitivity to beta blockers, carbonic anhydrase inhibitors or sulfa drugs

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Brinzolamide suspension, 1%

    Levobetaxolol suspension, 0.5%

    Arm Description

    Dosed twice daily for 12 weeks

    Dosed twice daily for 12 weeks

    Outcomes

    Primary Outcome Measures

    Mean Change from Baseline IOP

    Secondary Outcome Measures

    Full Information

    First Posted
    May 28, 2003
    Last Updated
    November 16, 2016
    Sponsor
    Alcon Research
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00061516
    Brief Title
    Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
    Official Title
    Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2003 (undefined)
    Primary Completion Date
    February 2006 (Actual)
    Study Completion Date
    February 2006 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    The purpose of this study is to evaluate the safety and efficacy of both BETAXON and AZOPT in pediatric patients. Patients will dose with study drug at 8 am and 8 pm daily for twelve weeks. Patients will have vision tested, slit lamp exam, blood pressure and pulse checks at each visit. Patients will have a dilated fundus exam and corneal measurements taken at first and last visit.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glaucoma, Ocular Hypertension
    Keywords
    Glaucoma, Ocular Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    78 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Brinzolamide suspension, 1%
    Arm Type
    Experimental
    Arm Description
    Dosed twice daily for 12 weeks
    Arm Title
    Levobetaxolol suspension, 0.5%
    Arm Type
    Experimental
    Arm Description
    Dosed twice daily for 12 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    BETAXON (levobetaxolol HCl)
    Intervention Description
    levobetaxolol suspension, 0.5%
    Intervention Type
    Drug
    Intervention Name(s)
    AZOPT (brinzolamide)
    Intervention Description
    brinzolamide suspension, 1%
    Primary Outcome Measure Information:
    Title
    Mean Change from Baseline IOP
    Time Frame
    Up to Week 12

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Week
    Maximum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    INCLUSION: Children 5 years old and younger require treatment for glaucoma or ocular hypertension vision is 20/80 or better cup-to-disc ratio of 0.8 or less EXCLUSION: do not have abnormal fixation IOP greater than 36 mm Hg significant retinal disease penetrating keratoplasty severe ocular pathology optic atrophy eye surgery in the past 30 days cardiovascular abnormalities hypersensitivity to beta blockers, carbonic anhydrase inhibitors or sulfa drugs

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18289898
    Citation
    Whitson JT, Roarty JD, Vijaya L, Robin AL, Gross RD, Landry TA, Dickerson JE, Scheib SA, Scott H, Hua SY, Woodside AM, Bergamini MV; Brinzolamide Pediatric Study Group. Efficacy of brinzolamide and levobetaxolol in pediatric glaucomas: a randomized clinical trial. J AAPOS. 2008 Jun;12(3):239-246.e3. doi: 10.1016/j.jaapos.2007.11.004. Epub 2008 Mar 4.
    Results Reference
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    Safety and Efficacy Study of BETAXON 0.5% and AZOPT 1.0% in Pediatric Patients With Glaucoma or Ocular Hypertension

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