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

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Alcon

Status

Completed

Conditions

Dry Eye

Treatments

Other: Ophthalmic dye
Device: Contact lenses

Study type

Observational

Funder types

Industry

Identifiers

NCT01611922
P/365/11/L

Details and patient eligibility

About

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.

Enrollment

57 patients

Sex

All

Ages

17+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

57 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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