Fitting Children With Contact Lenses
Not Applicable
Completed
- Conditions
- Refractive Error
- 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
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
- Primary Outcome Measures
Name Time Method Visual acuity 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.
PREP score 3 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Waterloo
🇨🇦Waterloo, Ontario, Canada
University of Waterloo🇨🇦Waterloo, Ontario, Canada