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

CIBA VISION1 site in 1 country194 target enrollmentSeptember 2010

ConditionsRefractive Error

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Refractive Error
Sponsor: CIBA VISION
Enrollment: 194
Locations: 1
Primary Endpoint: Visual acuity
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 2010

End Date

August 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CIBA VISION

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Visual acuity

Time Frame: 3 months

Ease of fit

Time Frame: 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.

PREP score

Time Frame: 3 months