Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2010-07-31
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Phase 1: Habitual no Replacement, then Habitual Replacement
Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a replacement pair dispensed at Day 28.
Habitual contact lens
Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
Phase 1: Habitual Replacement, then Habitual no Replacement
Contact lenses per participant's habitual prescription worn for 30 days with replacement pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.
Habitual contact lens
Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
Phase 2: Lotrafilcon B Replacement
Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
Lotrafilcon B contact lens
Commercially marketed silicone hydrogel contact lens
Contact lens cleaning and disinfecting system (ClearCare)
Commercially marketed, hydrogen peroxide-based contact lens care system
Phase 3: Lotrafilcon B Replacement Replacement
Contact lenses worn for 43 days with replacement pair dispensed at Day 1 and Day 28.
Lotrafilcon B contact lens
Commercially marketed silicone hydrogel contact lens
Contact lens cleaning and disinfecting system (ClearCare)
Commercially marketed, hydrogen peroxide-based contact lens care system
Interventions
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Habitual contact lens
Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
Lotrafilcon B contact lens
Commercially marketed silicone hydrogel contact lens
Contact lens cleaning and disinfecting system (ClearCare)
Commercially marketed, hydrogen peroxide-based contact lens care system
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ocular exam in the last two years.
* Currently wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis with a monthly replacement schedule.
* Wearing contact lenses at least five days per week for a minimum of 10 hours each day.
* Able to wear lenses in the available power range with a best-corrected visual acuity of at least 20/32 in both eyes.
Exclusion Criteria
* Systemic condition that may affect a study outcome.
* Using any systemic or topical medications that may affect ocular health.
* Wears lenses on an extended or continuous wear schedule.
* Habitually wears multifocal lenses.
17 Years
ALL
No
Sponsors
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University of Waterloo
OTHER
CIBA VISION
INDUSTRY
Responsible Party
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Principal Investigators
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Desmond Fonn, MOptom FAAO
Role: STUDY_DIRECTOR
University of Waterloo Centre for Contact Lens Research
Locations
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University of Waterloo
Waterloo, Ontario, Canada
Countries
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Other Identifiers
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P-373-C-006
Identifier Type: -
Identifier Source: org_study_id