Study Results
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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COMPLETED
NA
194 participants
INTERVENTIONAL
2010-09-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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CARE
Investigational single-vision contact lenses worn bilaterally on a daily wear basis and replaced monthly
Lotrafilcon B contact lens, investigational
Investigational silicone hydrogel, spherical 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
AIR OPTIX AQUA
Commercially available single-vision contact lenses worn bilaterally 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.
Contact lens care system (ClearCare)
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
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
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
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
8 Years
16 Years
ALL
No
Sponsors
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University of Waterloo
OTHER
CIBA VISION
INDUSTRY
Responsible Party
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Locations
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University of Waterloo
Waterloo, Ontario, Canada
Countries
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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.
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