Fitting Children With Contact Lenses

CIBA VISION194 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

194

Conditions

Refractive Error

Interventions

Lotrafilcon B contact lens, investigationalDEVICE

Investigational silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly

Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)DEVICE

Commercially available silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly.

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

Commercially available silicone hydrogel, multifocal, contact lens worn on a daily wear basis and replaced monthly.

Eligibility

Sex: ALLMin age: 8 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Waterloo

Waterloo, Ontario, Canada

Outcomes

Primary Outcomes

Visual acuity

Time frame: 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.

Time frame: 1 week

PREP score

Time frame: 3 months

Data from ClinicalTrials.gov

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