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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01611922
First received: May 31, 2012
Last updated: June 4, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention
Dry Eye
 Other: Ophthalmic dye
Device: Contact lenses

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

Resource links provided by NLM:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • LWE-associated staining score [ Time Frame: 3 minutes after dye instillation ] [ Designated as safety issue: No ]
    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.


Enrollment: 57
Study Start Date: April 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Symptomatic Lens Wearers
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
Topically instilled for the purpose of assessing lid margin staining
Other Names:
  • Lissamine Green
  • Sodium Fluorescein
Device: Contact lenses
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.
Non-Symptomatic Contact Lens Wearers
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
Topically instilled for the purpose of assessing lid margin staining
Other Names:
  • Lissamine Green
  • Sodium Fluorescein
Device: Contact lenses
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.
Asymptomatic Non-Contact Lens Wearers
Non-contact lens wearers reporting a minimal reduction in ocular comfort over the course of a day
 Other: Ophthalmic dye
Topically instilled for the purpose of assessing lid margin staining
Other Names:
  • Lissamine Green
  • Sodium Fluorescein

  Eligibility

Ages Eligible for Study:   17 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Participants will be identified and screened by the University of Waterloo in Ontario, Canada.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611922

Locations
Canada
Centre for Contact Lens Research, University of Waterloo
Waterloo, Canada, N2L 3G1
Sponsors and Collaborators
Alcon Research
Investigators
Principal Investigator: Lyndon Jones, FCOptom, PhD Centre for Contact Lens Research, School of Optometry, University of Waterloo
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01611922     History of Changes
Other Study ID Numbers: P/365/11/L
Study First Received: May 31, 2012
Last Updated: June 4, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Alcon Research:
eye
eyelid
contact lenses
dry eye disease

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
 Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases

ClinicalTrials.gov processed this record on May 16, 2013