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

Phase 4

Completed

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

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Eye 2: High coefficient of friction	Air Optix Night & Day Aqua	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
Eye 1: Low coefficient of friction	Acuvue Oasys	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.

Primary Outcome Measures

Name	Time	Method
Lid Wiper Epitheliopathy	One week post contact lens fitting	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.

Secondary Outcome Measures

Name	Time	Method
Lid Wiper Epitheliopathy	2 hours post contact lens fitting	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.