Fitting Children With Contact Lenses (COPPER)

Ciba Vision

Status: Completed

Conditions: Refractive Error

Treatments: Device: Contact lens care system (ClearCare); 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)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01233089

P-368-C-107

P/346/10/C (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 194 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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194 participants in 3 patient groups

CARE

Experimental group

Description:

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

Treatment:

Device: Lotrafilcon B contact lens, investigational

Device: Contact lens care system (ClearCare)

AIR OPTIX AQUA

Active Comparator group

Description:

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

Treatment:

Device: Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)

Device: Contact lens care system (ClearCare)

AIR OPTIX AQUA MULTIFOCAL

Active Comparator group

Description:

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

Treatment:

Device: Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)

Device: Contact lens care system (ClearCare)