Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

Dry Eye Clinical Trial

— BURNABY  

Official title:

Optimization of Assessment and Grading for Lid Wiper Epitheliopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611922
• Other study ID #: P/365/11/L
• Status: Completed
• Phase: N/A
• First received: May 31, 2012
• Last updated: June 4, 2012
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: June 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 17 Years and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Dry Eye

Intervention

Other:
• Ophthalmic dye
Topically instilled for the purpose of assessing lid margin staining

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.

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No