Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

N/ACompletedNCT01611922

Alcon Research57 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Dry Eye

Interventions

Ophthalmic dyeOTHER

Topically instilled for the purpose of assessing lid margin staining

Contact lensesDEVICE

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.

Eligibility

Sex: ALLMin age: 17 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Canada

Outcomes

Primary Outcomes

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.

Time frame: 3 minutes after dye instillation

Data from ClinicalTrials.gov

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