Phase 4
N=20
The Impact of Contact Lens Coefficient of Friction (CoF) on the Development of Lid Wiper Epitheliopathy (LWE)
Lid Wiper Epitheliopathy
Bottom Line
View on ClinicalTrials.gov: NCT03209505 ↗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
| Outcome | Result | p-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
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.