Fitting Children With Contact Lenses

Refractive Error Clinical Trial

— COPPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01233089
• Other study ID #: P-368-C-107
• Secondary ID: P/346/10/C
• Status: Completed
• Phase: N/A
• First received: November 1, 2010
• Last updated: November 17, 2016
• Start date: September 2010
• Est. completion date: August 2011

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• Lotrafilcon B contact lens, investigational
Investigational silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly
• Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)
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)
Commercially available silicone hydrogel, multifocal, contact lens worn on a daily wear basis and replaced monthly.
• Contact lens care system (ClearCare)
Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses

Locations

Country	Name	City	State
Canada	University of Waterloo	Waterloo	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
CIBA VISION	University of Waterloo

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

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