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Fitting Children With Contact Lenses (COPPER)

This study has been completed.
Sponsor:
Collaborator:
University of Waterloo
Information provided by (Responsible Party):
Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier:
NCT01233089
First received: November 1, 2010
Last updated: October 16, 2012
Last verified: September 2011

November 1, 2010
October 16, 2012
September 2010
August 2011   (final data collection date for primary outcome measure)
  • Visual acuity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ease of fit [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    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.
  • PREP score [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Visual acuity [ Time Frame: 3 months of wear time ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01233089 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Fitting Children With Contact Lenses
Quality of Life and Ease of Fit, Fitting Children With Contact Lenses

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Refractive Error
  • Device: Lotrafilcon B contact lens, investigational
    Investigational silicone hydrogel, spherical contact lens worn 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 Name: AIR OPTIX AQUA
  • 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 Name: AIR OPTIX AQUA MULTIFOCAL
  • Device: Contact lens care system (ClearCare)
    Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses
    Other Name: CLEAR CARE
  • Experimental: CARE
    Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly
    Interventions:
    • Device: Lotrafilcon B contact lens, investigational
    • Device: Contact lens care system (ClearCare)
  • Active Comparator: AIR OPTIX AQUA
    Commercially available single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly
    Interventions:
    • Device: Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)
    • Device: Contact lens care system (ClearCare)
  • Active Comparator: AIR OPTIX AQUA MULTIFOCAL
    Commercially available multifocal contact lenses worn bilaterally on a daily wear basis and replaced monthly
    Interventions:
    • Device: Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)
    • Device: Contact lens care system (ClearCare)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
194
August 2011
August 2011   (final data collection date for primary outcome measure)

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.
Both
8 Years to 16 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01233089
P-368-C-107, P/346/10/C
No
Alcon Research ( CIBA VISION )
CIBA VISION
University of Waterloo
Not Provided
Alcon Research
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP