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COPPER: Fitting Children With Contact Lenses

Sponsor
CIBA VISION (Industry)
Overall Status
Completed
CT.gov ID
NCT01233089
Collaborator
University of Waterloo (Other)
194
Enrollment
1
Location
3
Arms
11
Duration (Months)
17.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this three-month study is to compare the quality of life and ease of fit among children wearing investigational single-vision contact lenses, commercially marketed single-vision contact lenses, and commercially marketed multifocal contact lenses.

Condition or Disease Intervention/Treatment Phase
  • Device: Lotrafilcon B contact lens, investigational
  • Device: Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)
  • Device: Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)
  • Device: Contact lens care system (ClearCare)
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
194 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Quality of Life and Ease of Fit, Fitting Children With Contact Lenses
Study Start Date :
Sep 1, 2010
Actual Primary Completion Date :
Aug 1, 2011
Actual Study Completion Date :
Aug 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: CARE

Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly

Device: Lotrafilcon B contact lens, investigational
Investigational silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly

Device: Contact lens care system (ClearCare)
Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses
Other Names:
  • CLEAR CARE

    		•
    Active Comparator: AIR OPTIX AQUA

    Commercially available single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly

    Device: Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)
    Commercially available silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly.
    Other Names:
  • AIR OPTIX AQUA

    • Device: Contact lens care system (ClearCare)
    Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses
    Other Names:
  • CLEAR CARE

    		•
    Active Comparator: AIR OPTIX AQUA MULTIFOCAL

    Commercially available multifocal contact lenses worn bilaterally on a daily wear basis and replaced monthly

    Device: Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)
    Commercially available silicone hydrogel, multifocal, contact lens worn on a daily wear basis and replaced monthly.
    Other Names:
  • AIR OPTIX AQUA MULTIFOCAL

    • Device: Contact lens care system (ClearCare)
    Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses
    Other Names:
  • CLEAR CARE

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [3 months]

    2. Ease of fit [1 week]

      A participant was deemed to be successfully fit if they could insert/remove, handle and maintain study lenses by the 1-week visit and continued in the study.

    3. PREP score [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Is between 8 and 16 years of age.

    • Has the permission of a parent/legal guardian.

    • Is willing and able to, or has a parent/legal guardian who is willing and able to help them, follow instructions and maintain the appointment schedule.

    • Has had an ocular examination in the last two years.

    • Has never worn contact lenses before.

    • Has clear corneas and no active ocular disease.

    • Can be successfully fit with the lenses to be used in the study.

    • Has 20/25 or better best corrected visual acuity in each eye.

    • Other protocol-defined inclusion/exclusion criteria may apply.

    Exclusion Criteria:

    • Has any ocular disease.

    • Has a systemic condition that may affect a study outcome variable.

    • Is using any systemic or topical medications that may affect ocular health.

    • Has ocular or systemic allergies that could interfere with contact lens wear.

    • Has any ocular pathology or condition that would affect the wearing of contact lenses.

    • Other protocol-defined inclusion/exclusion criteria may apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Waterloo Waterloo Ontario Canada N2L 3G1

    Sponsors and Collaborators

    • CIBA VISION
    • University of Waterloo

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CIBA VISION
    ClinicalTrials.gov Identifier:
    NCT01233089
    Other Study ID Numbers:
    • P-368-C-107
    • P/346/10/C
    First Posted:
    Nov 3, 2010
    Last Update Posted:
    Nov 21, 2016
    Last Verified:
    Sep 1, 2011
    Keywords provided by CIBA VISION
    Myopia
    contact lenses
    children
    Additional relevant MeSH terms:
    Refractive Errors

    Study Results

    No Results Posted as of Nov 21, 2016