Fitting Children With Contact Lenses

NCT ID: NCT01233089

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Refractive Error

Keywords

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Myopia contact lenses children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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CARE

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

Group Type EXPERIMENTAL

Lotrafilcon B contact lens, investigational

Intervention Type DEVICE

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

Contact lens care system (ClearCare)

Intervention Type DEVICE

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

AIR OPTIX AQUA

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

Group Type ACTIVE_COMPARATOR

Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)

Intervention Type DEVICE

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

Contact lens care system (ClearCare)

Intervention Type DEVICE

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

AIR OPTIX AQUA MULTIFOCAL

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DEVICE

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

Contact lens care system (ClearCare)

Intervention Type DEVICE

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

Interventions

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Lotrafilcon B contact lens, investigational

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

Intervention Type DEVICE

Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)

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

Intervention Type DEVICE

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.

Intervention Type DEVICE

Contact lens care system (ClearCare)

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

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX AQUA AIR OPTIX AQUA MULTIFOCAL CLEAR CARE

Eligibility Criteria

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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.

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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Waterloo

OTHER

Sponsor Role collaborator

CIBA VISION

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Waterloo

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 26070228 (View on PubMed)

Other Identifiers

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P/346/10/C

Identifier Type: OTHER

Identifier Source: secondary_id

P-368-C-107

Identifier Type: -

Identifier Source: org_study_id