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

NCT03209505 | Completed Phase 4 Results FDA Device

• 1 other identifier: STUDY00000386
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lid Wiper Epitheliopathy

Keywords

Lid Wiper Epitheliopahty; Coefficient of Friction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Lid Wiper Epitheliopathy

  2 hours post contact lens fitting

Study Arms (2)

Eye 1: Low coefficient of friction

OTHER

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

Eye 2: High coefficient of friction

OTHER

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

Interventions

Acuvue Oasys DEVICE

FDA approved contact lens, fit for daily wear

Eye 1: Low coefficient of friction

Air Optix Night & Day Aqua DEVICE

FDA approved contact lens, fit for daily wear

Eye 2: High coefficient of friction

Eligibility Criteria

• Age: 18 Years - 46 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Houston: lead

Study Sites (1)

The Ocular Surface Institute, The University of Houston College of Optometry

Houston, Texas, 77204, United States

Location

Results Point of Contact

• Title: Eric Ritchey, OD, PhD
• Organization: University of Houston College of Optometry

erritche@central.uh.edu

713-743-1933

Study Officials

• Eric R Ritchey, OD, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

• Rachel Redfern, OD, PhD

  University of Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2017
• First Posted: July 6, 2017
• Study Start: June 26, 2017
• Primary Completion: April 13, 2018
• Study Completion: April 13, 2018
• Last Updated: August 31, 2021
• Results First Posted: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)