The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)
Condition: Lid Wiper Epitheliopathy
Intervention: Acuvue Oasys; Air Optix Night & Day Aqua
Intervention description: FDA approved contact lens, fit for daily wear; FDA approved contact lens, fit for daily wear
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking description: Subjects will be masked to the contact lens brand fit in each eye. The subject's Lid Wiper Epitheliopathy will be graded using photographs of the eyelid, where the grader is masked to the lens type in each eye.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 46 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Lid Wiper Epitheliopahty; Coefficient of Friction

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          1. Must be able to read and understand the study informed consent

          2. Must be a minimum of 18 years of age and less than 46 years of age at study enrollment

          3. 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

          4. Have a spherical equivalent refractive error between -0.75 to -6.50DS at the spectacle
             plane

          5. The subject must be able to attend study visits at the prescribed visit times and
             adhere to the study instructions

        Exclusion Criteria:

          1. Pregnant and/or lactating females by self-report

          2. Presence of current LWE on the upper eyelid (>0.5 in height or width)

          3. Has greater than -1.00DC of refractive cylinder

          4. Has greater than 1.00D of anisometropia

          5. Is aphakic

          6. Has clinically significant corneal or conjunctival staining that would prevent contact
             lens fitting, as assessed with sodium fluorescein dye

          7. Has significant ocular surface disease (e.g. Sjögrens Disease, Stevens-Johnson
             Syndrome, etc.) or significant Dry Eye Syndrome

          8. Has clinically significant corneal vascularization or central corneal scaring

          9. Has active ocular surface infection (e.g. conjunctivitis)

         10. Has a positive history of eyelid surgery or trauma

         11. Has a positive history of refractive surgery

         12. Takes medications that significantly impact contact lens comfort and/or ocular surface
             health

         13. Has taken part in another contact lens or contact lens solution clinical trial within
             the last 7 days

         14. Is unwilling to have eyes photographed or video recorded