NCT03209505

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: University of Houston · Academic / Other
• Sex: All
• Age: 18 Years – 46 Years
• Healthy volunteers: Accepted

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.

Conditions

• Lid Wiper Epitheliopathy

Interventions

Type	Name	Description
DEVICE	Acuvue Oasys	FDA approved contact lens, fit for daily wear
DEVICE	Air Optix Night & Day Aqua	FDA approved contact lens, fit for daily wear

Timeline

• Start date: 2017-06-26
• Primary completion: 2018-04-13
• Completion: 2018-04-13
• First posted: 2017-07-06
• Last updated: 2021-08-31
• Results posted: 2021-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study