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OpenTrials
Completed

NCT Number: NCT01233089

Fitting Children With Contact Lenses

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.

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Key information

Conditions

Refractive Error Eye Diseases Myopia Refractive Errors

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon B contact lens, investigational

Device

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

Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)

Device

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

Other names: AIR OPTIX AQUA

Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)

Device

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

Other names: AIR OPTIX AQUA MULTIFOCAL

Contact lens care system (ClearCare)

Device

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

Other names: CLEAR CARE

Primary outcomes

  1. Visual acuity

    Time frame: 3 months

  2. 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.

  3. PREP score

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

CIBA VISION

Industry

Collaborators

  • University of Waterloo

Registry information

Official study title

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

Acronym: COPPER

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 3, 2010
Registry last updated
Nov 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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