The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)

Study Overview
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Brief Summary
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This study examines the development of Lid Wiper Epitheliopathy (LWE) in individuals fit with contact lenses having difference coefficients of friction (CoF)

Detailed Description
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The primary study objectives are to determine the amount of Lid Wiper Epitheliopathy (LWE) induced in subjects after contact lens fitting that do not have LWE at study enrollment. Subjects in the trial will be fit in 2 contact lenses with different coefficients of friction (CoF). One eye will be fit in a contact lens with a low coefficient of friction (Acuvue Oasys®, Johnson & Johnson Vision, Jacksonville FL) while the contralateral eye will be fit in a contact lens with a high CoF (Air Optix® Night & Day® Aqua, Ft. Worth, TX), as reported in the scientific literature. The eye receiving each lens will be assigned randomly. The presence of LWE will be assessed at 2 different time points, approximately 2 hours after contact lens fitting and approximately after 7 days of contact lens wear.

Official Title
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The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)

Conditions
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Lid Wiper Epitheliopathy

Intervention / Treatment
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* Device: Acuvue Oasys
* Device: Air Optix Night & Day Aqua


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be able to read and understand the study informed consent Must be a minimum of 18 years of age and less than 46 years of age at study enrollment Must be healthy non-soft contact lens wearers (neophytes), or experienced contact lens wearers that have not worn their contact lenses for a minimum of 7 days Have a spherical equivalent refractive error between -0.75 to -6.50DS at the spectacle plane The subject must be able to attend study visits at the prescribed visit times and adhere to the study instructions Exclusion Criteria: Pregnant and/or lactating females by self-report Presence of current LWE on the upper eyelid (>0.5 in height or width) Has greater than -1.00DC of refractive cylinder Has greater than 1.00D of anisometropia Is aphakic Has clinically significant corneal or conjunctival staining that would prevent contact lens fitting, as assessed with sodium fluorescein dye Has significant ocular surface disease (e.g. Sjögrens Disease, Stevens-Johnson Syndrome, etc.) or significant Dry Eye Syndrome Has clinically significant corneal vascularization or central corneal scaring Has active ocular surface infection (e.g. conjunctivitis) Has a positive history of eyelid surgery or trauma Has a positive history of refractive surgery Takes medications that significantly impact contact lens comfort and/or ocular surface health Has taken part in another contact lens or contact lens solution clinical trial within the last 7 days Is unwilling to have eyes photographed or video recorded

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 46 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. One eye will be fit in a contact lens with a low coefficient of friction while the contralateral eye will be fit in a contact lens with a high coefficient of friction.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Eye 1: Low coefficient of friction<br>Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 1 will be fit in a contact lens with a low coefficient of friction, Acuvue Oasys. | Device: Acuvue Oasys<br>* FDA approved contact lens, fit for daily wear<br>|
| Other: Eye 2: High coefficient of friction<br>Subjects will be fit in a different contact lens brand in each eye. Assignment of the contact lens to each eye will be randomized. Eye 2 One eye will be fit in a contact lens with a high coefficient of friction, Air Optix Night & Day Aqua | Device: Air Optix Night & Day Aqua<br>* FDA approved contact lens, fit for daily wear<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lid Wiper Epitheliopathy | Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy. | One week post contact lens fitting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lid Wiper Epitheliopathy | Lid Wiper Staining of the Upper Eyelid. The lid wiper region of the eyelid is the portion of the marginal conjunctival epithelium that moves across the ocular surface or contact lens during blinking. Participants were classified according to their lid wiper epitheliopathy grade for each eye using the following scale: None = 0, Mild = 0.25 - 1.00, Moderate = 1.25 - 2.00, and Severe = 2.25 - 3.00. Grades range from 0 to 3, where higher grades indicate worsening lid wiper epitheliopathy. | 2 hours post contact lens fitting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lid Wiper Epitheliopahty, Coefficient of Friction