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

History of Changes

Tracking Information
First Received Date ^ICMJE	November 1, 2010
Last Updated Date	October 16, 2012
Start Date ^ICMJE	September 2010
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 16, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE (submitted: November 1, 2010)	Visual acuity [ Time Frame: 3 months of wear time ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01233089 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Fitting Children With Contact Lenses
Official Title ^ICMJE	Quality of Life and Ease of Fit, Fitting Children With Contact Lenses
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Refractive Error
Intervention ^ICMJE	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
Study Arm (s)	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)
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	194
Completion Date	August 2011
Primary Completion Date	August 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	8 Years to 16 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01233089
Other Study ID Numbers ^ICMJE	P-368-C-107, P/346/10/C
Has Data Monitoring Committee	No
Responsible Party	Alcon Research ( CIBA VISION )
Study Sponsor ^ICMJE	CIBA VISION
Collaborators ^ICMJE	University of Waterloo
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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