NCT01233089

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 21, 2016

Status Verified

September 1, 2011

Enrollment Period

11 months

First QC Date

November 1, 2010

Last Update Submit

November 17, 2016

Conditions

Refractive Error

Keywords

Myopiacontact lenseschildren

Outcome Measures

Primary Outcomes (3)

  • Visual acuity

    3 months

  • 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

  • PREP score

    3 months

Study Arms (3)

CARE

EXPERIMENTAL

Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly

Device: Lotrafilcon B contact lens, investigationalDevice: Contact lens care system (ClearCare)

AIR OPTIX AQUA

ACTIVE COMPARATOR

Commercially available single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly

Device: Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)Device: Contact lens care system (ClearCare)

AIR OPTIX AQUA MULTIFOCAL

ACTIVE COMPARATOR

Commercially available multifocal contact lenses worn bilaterally on a daily wear basis and replaced monthly

Device: Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)Device: Contact lens care system (ClearCare)

Interventions

Lotrafilcon B contact lens, investigationalDEVICE

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

CARE
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.

Also known as: AIR OPTIX AQUA
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.

Also known as: AIR OPTIX AQUA MULTIFOCAL
AIR OPTIX AQUA MULTIFOCAL
Contact lens care system (ClearCare)DEVICE

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

Also known as: CLEAR CARE
AIR OPTIX AQUAAIR OPTIX AQUA MULTIFOCALCARE

Eligibility Criteria

Age8 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

Related 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. Epub 2015 Jun 9.

    PMID: 26070228RESULT

MeSH Terms

Conditions

Refractive ErrorsMyopia

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2010

First Posted

November 3, 2010

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 21, 2016

Record last verified: 2011-09

Locations

CA(1)