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Completed

NCT Number: NCT03209505

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)

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Key information

Age range

18 year–46 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Houston, Texas, 77204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Acuvue Oasys

Device

FDA approved contact lens, fit for daily wear

Air Optix Night & Day Aqua

Device

FDA approved contact lens, fit for daily wear

Primary outcomes

  1. Lid Wiper Epitheliopathy

    Time frame: One week post contact lens fitting

    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.

Secondary outcomes

  1. Lid Wiper Epitheliopathy

    Time frame: 2 hours post contact lens fitting

    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.

Sponsors and collaborators

Lead sponsor

University of Houston

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 6, 2017
Registry last updated
Aug 31, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.