Study of the Cell Response in the Tear Film After Overnight Contact Lens Wear
NCT ID: NCT01379768
Last Updated: 2013-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2011-05-31
2012-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Lotrafilcon A
Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
Lotrafilcon A contact lens
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.
Clear Care Cleaning and Disinfection Solution
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Lotrafilcon B
Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
Clear Care Cleaning and Disinfection Solution
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
No lens wear
No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
No interventions assigned to this group
Interventions
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Lotrafilcon A contact lens
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.
Lotrafilcon B contact lens
Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
Clear Care Cleaning and Disinfection Solution
Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ocular examination in the last two years.
* Has up-to-date spectacles.
* Falls into one of the following three categories:
* Adapted wearer of Lotrafilcon A contact lenses
* Adapted wearer of Lotrafilcon B contact lenses
* Does not wear contact lenses
Exclusion Criteria
* Systemic or topical medications that may affect ocular health.
* Known sensitivity to diagnostic pharmaceuticals used in study.
* Uses artificial tears and/or rewetting drops.
* Wears contact lenses on an overnight basis for more than one night per week.
17 Years
ALL
Yes
Sponsors
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University of Waterloo
OTHER
CIBA VISION
INDUSTRY
Responsible Party
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Principal Investigators
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Lyndon Jones, PhD FCOptom FAAO, Director
Role: PRINCIPAL_INVESTIGATOR
Centre for Contact Lens Research, School of Optometry, University of Waterloo
Locations
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University of Waterloo Centre for Contact Lens Research
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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P-373-C-102
Identifier Type: -
Identifier Source: org_study_id
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