Fitting Children With Contact Lenses

Study Overview
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Brief Summary
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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.

Official Title
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Quality of Life and Ease of Fit, Fitting Children With Contact Lenses

Conditions
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Refractive Error

Intervention / Treatment
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* 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)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CARE<br>Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly | Device: Lotrafilcon B contact lens, investigational<br>* Investigational silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly<br>Device: Contact lens care system (ClearCare)<br>* Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses<br>* Other names: CLEAR CARE;|
| Active Comparator: AIR OPTIX AQUA<br>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)<br>* Commercially available silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly.<br>* Other names: AIR OPTIX AQUA;Device: Contact lens care system (ClearCare)<br>* Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses<br>* Other names: CLEAR CARE;|
| Active Comparator: AIR OPTIX AQUA MULTIFOCAL<br>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)<br>* Commercially available silicone hydrogel, multifocal, contact lens worn on a daily wear basis and replaced monthly.<br>* Other names: AIR OPTIX AQUA MULTIFOCAL;Device: Contact lens care system (ClearCare)<br>* Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses<br>* Other names: CLEAR CARE;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myopia, contact lenses, children