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Phase 4 N=20 Randomized Double-blind Basic Science

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

Lid Wiper Epitheliopathy

Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Lid Wiper Epitheliopathy — 0.63; 0.25 score on a scale

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Acuvue Oasys (Device); Air Optix Night & Day Aqua (Device)
Age
Adult · 18+ yrs
Sex
All
Sponsor
University of Houston
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Lid Wiper Epitheliopathy
0.75; 0.13
SECONDARY
Lid Wiper Epitheliopathy
0.75; 0.13

Summary

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

Eligibility Criteria

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03209505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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