Fitting Children With Contact Lenses

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01233089

Acronym

COPPER

Enrollment

194

Registered

2010-11-03

Start date

2010-09-30

Completion date

2011-08-31

Last updated

2016-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractive Error

Keywords

Myopia, contact lenses, children

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.

Interventions

DEVICELotrafilcon B contact lens, investigational

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

DEVICELotrafilcon B contact lens, commercial (AIR OPTIX AQUA)

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

DEVICELotrafilcon 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.

DEVICEContact lens care system (ClearCare)

Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

8 Years to 16 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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	—

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026