Optimization of Assessment and Grading for Lid Wiper Epitheliopathy
NCT ID: NCT01611922
Last Updated: 2012-06-05
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
57 participants
OBSERVATIONAL
2012-04-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Symptomatic Lens Wearers
Contact lens wearers reporting a habitual wear time of less than eight hours and a noticeable reduction in comfort over a wearing day
Ophthalmic dye
Topically instilled for the purpose of assessing lid margin staining
Contact lenses
Silicone hydrogel contact lenses per subject's habitual brand and power, worn for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled.
Non-Symptomatic Contact Lens Wearers
Contact lens wearers reporting a comfortable wear time of more than 10 hours and minimal reduction in comfort over a wearing day
Ophthalmic dye
Topically instilled for the purpose of assessing lid margin staining
Contact lenses
Silicone hydrogel contact lenses per subject's habitual brand and power, worn for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled.
Asymptomatic Non-Contact Lens Wearers
Non-contact lens wearers reporting a minimal reduction in ocular comfort over the course of a day
Ophthalmic dye
Topically instilled for the purpose of assessing lid margin staining
Interventions
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Ophthalmic dye
Topically instilled for the purpose of assessing lid margin staining
Contact lenses
Silicone hydrogel contact lenses per subject's habitual brand and power, worn for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Has read and signed an information consent letter;
* Is willing and able to follow instructions and maintain the appointment schedule;
* Has had an ocular examination in the last two years;
* Has clear corneas and no active ocular disease;
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 known sensitivity to the diagnostic pharmaceuticals to be used in the study;
* Has undergone corneal refractive surgery;
* Currently wears contact lenses on an extended wear basis (overnight);
* Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
17 Years
ALL
Yes
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Lyndon Jones, FCOptom, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre for Contact Lens Research, School of Optometry, University of Waterloo
Locations
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Centre for Contact Lens Research, University of Waterloo
Waterloo, , Canada
Countries
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Other Identifiers
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P/365/11/L
Identifier Type: -
Identifier Source: org_study_id
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