Fitting Children With Contact Lenses (COPPER)

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.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: Lotrafilcon B contact lens, investigational; Device: Contact lens care system (ClearCare); Device: Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA); Device: Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)

• Study Type: Interventional
• Enrollment (Actual): 194
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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: Contact lens care system (ClearCare); Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses; Other Names: CLEAR CARE; 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
ACTIVE_COMPARATOR: AIR OPTIX AQUA MULTIFOCAL; Commercially available multifocal contact lenses worn bilaterally 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual acuity		3 months
Ease of fit	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.	1 week
PREP score		3 months

Collaborators and Investigators

• Sponsor: CIBA VISION
• Collaborators: University of Waterloo

Publications and helpful links

General Publications

• Paquette L, Jones DA, Sears M, Nandakumar K, Woods CA. Contact lens fitting and training in a child and youth population. Cont Lens Anterior Eye. 2015 Dec;38(6):419-23. doi: 10.1016/j.clae.2015.05.002. Epub 2015 Jun 9.

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: November 1, 2010
• First Submitted That Met QC Criteria: November 1, 2010
• First Posted (ESTIMATE): November 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): November 21, 2016
• Last Update Submitted That Met QC Criteria: November 17, 2016
• Last Verified: September 1, 2011

More Information

Terms related to this study

• Keywords: children; Myopia; contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: P-368-C-107; P/346/10/C (OTHER: University of Waterloo)