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Completed

NCT Number: NCT01611922

Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

17 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ophthalmic dye

Other

Topically instilled for the purpose of assessing lid margin staining

Other names: Lissamine Green, Sodium Fluorescein

Contact Lenses

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.

Primary outcomes

  1. LWE-associated staining score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Acronym: BURNABY

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jun 5, 2012
Registry last updated
Jun 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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