Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

Completed

• Conditions: Dry Eye
• Interventions: Other: Ophthalmic dye; Device: Contact lenses

• Registration Number: NCT01611922
• Lead Sponsor: Alcon Research

Brief Summary

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

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-04
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Study First Submitted: 2012-05-31
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-04
• Last Update Submitted: 2012-06-04
• Study First Posted: 2012-06-05
• Last Update Posted: 2012-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Symptomatic Lens Wearers	Ophthalmic dye	Contact lens wearers reporting a habitual wear time of less than eight hours and a noticeable reduction in comfort over a wearing day
Symptomatic Lens Wearers	Contact lenses	Contact lens wearers reporting a habitual wear time of less than eight hours and a noticeable reduction in comfort over a wearing day
Non-Symptomatic Contact Lens Wearers	Ophthalmic dye	Contact lens wearers reporting a comfortable wear time of more than 10 hours and minimal reduction in comfort over a wearing day
Non-Symptomatic Contact Lens Wearers	Contact lenses	Contact lens wearers reporting a comfortable wear time of more than 10 hours and minimal reduction in comfort over a wearing day
Asymptomatic Non-Contact Lens Wearers	Ophthalmic dye	Non-contact lens wearers reporting a minimal reduction in ocular comfort over the course of a day

Primary Outcome Measures

Name	Time	Method
LWE-associated staining score	3 minutes after dye instillation	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.

Trial Locations

Locations (1)

Centre for Contact Lens Research, University of Waterloo; 🇨🇦 Waterloo, Canada