Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

NCT ID: NCT01611922

Last Updated: 2012-06-05

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

Total Enrollment

57 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-05-31

Brief Summary

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The purpose of this study is to assess eyelid margin staining, termed "lid wiper epitheliopathy" (LWE), in three populations. The hypothesis is LWE will be more prevalent in symptomatic contact lens wearers than non-symptomatic contact lens wearers and least prevalent in asymptomatic non-contact lens wearers.

Detailed Description

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Conditions

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Dry Eye

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type OTHER

Topically instilled for the purpose of assessing lid margin staining

Contact lenses

Intervention Type DEVICE

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

Intervention Type OTHER

Topically instilled for the purpose of assessing lid margin staining

Contact lenses

Intervention Type DEVICE

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

Intervention Type OTHER

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

Intervention Type OTHER

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.

Intervention Type DEVICE

Other Intervention Names

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Lissamine Green Sodium Fluorescein

Eligibility Criteria

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Inclusion Criteria

* Has full legal capacity to volunteer;
* 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 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 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;
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Canada

Other Identifiers

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P/365/11/L

Identifier Type: -

Identifier Source: org_study_id

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