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
  Purpose

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 Intervention
Refractive Error
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)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Quality of Life and Ease of Fit, Fitting Children With Contact Lenses

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • 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 ]

Enrollment: 194
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: AIR OPTIX AQUA
Device: Contact lens care system (ClearCare)
Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses
Other Name: 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 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

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233089

Locations
Canada, Ontario
University of Waterloo
Waterloo, Ontario, Canada, N2L 3G1
Sponsors and Collaborators
CIBA VISION
University of Waterloo
  More Information

No publications provided

Responsible Party: Alcon Research ( CIBA VISION )
ClinicalTrials.gov Identifier: NCT01233089     History of Changes
Other Study ID Numbers: P-368-C-107, P/346/10/C
Study First Received: November 1, 2010
Last Updated: October 16, 2012
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by Alcon Research:
Myopia
contact lenses
children

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on April 23, 2014