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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014