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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-26

Study Completion Date

2018-04-13

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)

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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.

Conditions

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Lid Wiper Epitheliopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

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.

Study Groups

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Eye 1: Low coefficient of friction

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.

Group Type OTHER

Acuvue Oasys

Intervention Type DEVICE

FDA approved contact lens, fit for daily wear

Eye 2: High coefficient of friction

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

Group Type OTHER

Air Optix Night & Day Aqua

Intervention Type DEVICE

FDA approved contact lens, fit for daily wear

Interventions

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Acuvue Oasys

FDA approved contact lens, fit for daily wear

Intervention Type DEVICE

Air Optix Night & Day Aqua

FDA approved contact lens, fit for daily wear

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

46 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes