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

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

Study Overview

• Status: Completed
• Conditions: Lid Wiper Epitheliopathy
• Intervention / Treatment: Device: Acuvue Oasys; Device: Air Optix Night & Day Aqua

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • The Ocular Surface Institute, The University of Houston College of Optometry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Device: Acuvue Oasys; FDA approved contact lens, fit for daily wear
Other: 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	Device: Air Optix Night & Day Aqua; FDA approved contact lens, fit for daily wear

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Houston
• Investigators: Principal Investigator: Eric R Ritchey, OD, PhD, University of Houston; Principal Investigator: Rachel Redfern, OD, PhD, University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Actual): April 13, 2018
• Study Completion (Actual): April 13, 2018

Study Registration Dates

• First Submitted: June 30, 2017
• First Submitted That Met QC Criteria: July 3, 2017
• First Posted (Actual): July 6, 2017

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 27, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Lid Wiper Epitheliopahty; Coefficient of Friction
• Other Study ID Numbers: STUDY00000386

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes