Optimization of Assessment and Grading for Lid Wiper Epitheliopathy (BURNABY)

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye
• Intervention / Treatment: Other: Ophthalmic dye; Device: Contact lenses

• Study Type: Observational
• Enrollment (Actual): 57

Contacts and Locations

Study Locations

• Canada
  • Waterloo, Canada, N2L 3G1
    • Centre for Contact Lens Research, University of Waterloo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be identified and screened by the University of Waterloo in Ontario, Canada.

Description

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;
• Other protocol-defined inclusion criteria may apply.

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;
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Ophthalmic dye; Topically instilled for the purpose of assessing lid margin staining; Other Names: Lissamine Green; Sodium Fluorescein; Device: 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	Other: Ophthalmic dye; Topically instilled for the purpose of assessing lid margin staining; Other Names: Lissamine Green; Sodium Fluorescein; Device: 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	Other: Ophthalmic dye; Topically instilled for the purpose of assessing lid margin staining; Other Names: Lissamine Green; Sodium Fluorescein

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
LWE-associated staining score	Lens wearers must wear lenses for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled. LWE-associated staining will be assessed by the investigator and reported as a composite score based on Korb's method.	3 minutes after dye instillation

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Principal Investigator: Lyndon Jones, FCOptom, PhD, Centre for Contact Lens Research, School of Optometry, University of Waterloo

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: May 31, 2012
• First Submitted That Met QC Criteria: June 4, 2012
• First Posted (Estimate): June 5, 2012

Study Record Updates

• Last Update Posted (Estimate): June 5, 2012
• Last Update Submitted That Met QC Criteria: June 4, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: contact lenses; eye; dry eye disease; eyelid
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: P/365/11/L