BURNABY: Optimization of Assessment and Grading for Lid Wiper Epitheliopathy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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:
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:
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:
|
Outcome Measures
Primary Outcome Measures
- LWE-associated staining score [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Has full legal capacity to volunteer;
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Has read and signed an information consent letter;
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Is willing and able to follow instructions and maintain the appointment schedule;
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Has had an ocular examination in the last two years;
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Has clear corneas and no active ocular disease;
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Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
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Has any ocular disease;
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Has a systemic condition that may affect a study outcome variable;
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Is using any systemic or topical medications that may affect ocular health;
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Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
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Has undergone corneal refractive surgery;
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Currently wears contact lenses on an extended wear basis (overnight);
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Has any clinically significant lid or conjunctival abnormalities, neovascularization, corneal scars or corneal opacities;
-
Other protocol-defined exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- P/365/11/L