Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

Study Overview
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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.

Official Title
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Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

Conditions
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Dry Eye

Intervention / Treatment
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* Other: Ophthalmic dye
* Device: Contact lenses


Participation Criteria
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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; 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.

Ages Eligible for Study
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Minimum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic Lens Wearers<br>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<br>* Topically instilled for the purpose of assessing lid margin staining<br>* Other names: Sodium Fluorescein;Device: Contact lenses<br>* 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.<br>|
| Non-Symptomatic Contact Lens Wearers<br>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<br>* Topically instilled for the purpose of assessing lid margin staining<br>* Other names: Sodium Fluorescein;Device: Contact lenses<br>* 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.<br>|
| Asymptomatic Non-Contact Lens Wearers<br>Non-contact lens wearers reporting a minimal reduction in ocular comfort over the course of a day | Other: Ophthalmic dye<br>* Topically instilled for the purpose of assessing lid margin staining<br>* Other names: Sodium Fluorescein;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eye, eyelid, contact lenses, dry eye disease