Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

NCT01611922 | Completed

• 1 other identifier: P/365/11/L
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dry Eye

Keywords

eye; eyelid; contact lenses; dry eye disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

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; Device: Contact lenses

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; Device: Contact lenses

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

Interventions

Ophthalmic dye OTHER

Topically instilled for the purpose of assessing lid margin staining

Also known as: Lissamine Green, Sodium Fluorescein

Asymptomatic Non-Contact Lens Wearers; Non-Symptomatic Contact Lens Wearers; Symptomatic Lens Wearers

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.

Non-Symptomatic Contact Lens Wearers; Symptomatic Lens Wearers

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Fluorescein; Contact Lenses

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Lyndon Jones, FCOptom, PhD

  Centre for Contact Lens Research, School of Optometry, University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2012
• First Posted: June 5, 2012
• Study Start: April 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

CA (1)