Fitting Children With Contact Lenses

Not Applicable

Completed

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

• Registration Number: NCT01233089
• Lead Sponsor: CIBA VISION

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 available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-03
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-09
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 194

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AIR OPTIX AQUA MULTIFOCAL	Contact lens care system (ClearCare)	Commercially available multifocal contact lenses worn bilaterally on a daily wear basis and replaced monthly
CARE	Lotrafilcon B contact lens, investigational	Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly
AIR OPTIX AQUA MULTIFOCAL	Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)	Commercially available multifocal contact lenses worn bilaterally on a daily wear basis and replaced monthly
AIR OPTIX AQUA	Contact lens care system (ClearCare)	Commercially available single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly
CARE	Contact lens care system (ClearCare)	Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly
AIR OPTIX AQUA	Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)	Commercially available single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly

Primary Outcome Measures

Name	Time	Method
Visual acuity	3 months
PREP score	3 months
Ease of fit	1 week	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.

Trial Locations

Locations (1)

University of Waterloo; 🇨🇦 Waterloo, Ontario, Canada