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Fitting Children With Contact Lenses (COPPER)

Primary Purpose

Refractive Error

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lotrafilcon B contact lens, investigational
Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)
Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)
Contact lens care system (ClearCare)
Sponsored by
CIBA VISION
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractive Error focused on measuring Myopia, contact lenses, children

Eligibility Criteria

8 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

CARE

AIR OPTIX AQUA

AIR OPTIX AQUA MULTIFOCAL

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Visual acuity
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.
PREP score

Secondary Outcome Measures

Full Information

First Posted
November 1, 2010
Last Updated
November 17, 2016
Sponsor
CIBA VISION
Collaborators
University of Waterloo
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1. Study Identification

Unique Protocol Identification Number
NCT01233089
Brief Title
Fitting Children With Contact Lenses
Acronym
COPPER
Official Title
Quality of Life and Ease of Fit, Fitting Children With Contact Lenses
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CIBA VISION
Collaborators
University of Waterloo

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractive Error
Keywords
Myopia, contact lenses, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
194 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CARE
Arm Type
Experimental
Arm Description
Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly
Arm Title
AIR OPTIX AQUA
Arm Type
Active Comparator
Arm Description
Commercially available single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly
Arm Title
AIR OPTIX AQUA MULTIFOCAL
Arm Type
Active Comparator
Arm Description
Commercially available multifocal contact lenses worn bilaterally on a daily wear basis and replaced monthly
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lens, investigational
Intervention Description
Investigational silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)
Other Intervention Name(s)
AIR OPTIX AQUA
Intervention Description
Commercially available silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly.
Intervention Type
Device
Intervention Name(s)
Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)
Other Intervention Name(s)
AIR OPTIX AQUA MULTIFOCAL
Intervention Description
Commercially available silicone hydrogel, multifocal, contact lens worn on a daily wear basis and replaced monthly.
Intervention Type
Device
Intervention Name(s)
Contact lens care system (ClearCare)
Other Intervention Name(s)
CLEAR CARE
Intervention Description
Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses
Primary Outcome Measure Information:
Title
Visual acuity
Time Frame
3 months
Title
Ease of fit
Description
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.
Time Frame
1 week
Title
PREP score
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
26070228
Citation
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.
Results Reference
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Fitting Children With Contact Lenses

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