Refractive Error Clinical Trial
— COPPEROfficial title:
Quality of Life and Ease of Fit, Fitting Children With Contact Lenses
Verified date | September 2011 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review CommitteeCanada: Health Canada |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 194 |
Est. completion date | August 2011 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 8 Years to 16 Years |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University of Waterloo | Waterloo | Ontario |
Lead Sponsor | Collaborator |
---|---|
CIBA VISION | University of Waterloo |
Canada,
Paquette L, Jones DA, Sears M, Nandakumar K, Woods CA. Contact lens fitting and training in a child and youth population. Cont Lens Anterior Eye. 2015 Dec;38(6):419-23. doi: 10.1016/j.clae.2015.05.002. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Visual acuity | 3 months | No | |
Primary | 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 | No |
Primary | PREP score | 3 months | No |
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