Skip to main content
OpenTrials
Completed

NCT Number: NCT06671041

Treating Lid Wiper Epitheliopathy

Lid wiper epitheliopathy (LWE) is a relatively new entry into the abundance of clinical ocular surface health signs. LWE was first reported in 2002 as a potential cause for dry eye disease (DED) (Korb et al., 2002). This clinical sign is visualised by everting the eyelid after a dye has been applied and observing the palpebral conjunctiva proximal to the eyelashes

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Maitland Vision Center, Orlando, Florida, United States

Loading trial locations.

About this study

Lid wiper epitheliopathy (LWE) is a relatively new entry into the abundance of clinical ocular surface health signs. LWE was first reported in 2002 as a potential cause for dry eye disease. This clinical sign is visualised by everting the eyelid after a dye has been applied and observing the palpebral conjunctiva proximal to the eyelashes. An observable line at the mucocutaneous junction, called the line of Marx, is present in all eyelids and any further staining of the tissue in the palpebral marginal conjunctiva can be regarded as LWE. LWE has been described as a micro-trauma caused by inadequate ocular lubrication and/or excessive friction. The lid wiper is one of the most sensitive conjunctival tissue areas of the ocular surface and upper eyelid LWE has been reported to be highly correlated to ocular surface discomfort and DED

Korb, theorised some plausible aetiologies for LWE. They were all ultimately linked to frictional related damaged initiated by 1) tear film dysfunction not including tear volume (since normal Schirmer testing was an inclusion in their study), 2) localised disorders of the lid wiper itself, 3) aberrant blinking, 4) ocular surface abnormalities at the cellular level (subclinical) to initiate excessive localised trauma, and 5) conditions that would lead to inflammation of the lid wiper.

The TFOS executive summary determined that a complete review of the clinical trials revealed a potential link of LWE to DED and suggested that future trials be performed to make conclusions as to which interventions might deliver the greatest impact Because LWE has been linked to DED, most of the proposed treatment strategies to relieve LWE have paralleled after treatments for DED and MGD. Treatment options fall into several categories. They are as follows: blinking, tear supplements and lubricants, tear retention agents, tear stimulants (secretagogues), biological tear substitutes, anti-inflammatory therapy, essential fatty acids, treatment of MGD and environmental strategies (including in-office treatments).

Excessive tear evaporation due to a deficient lipid layer is believed to be the most common cause of DED, and most evaporative DED is associated with MGD. Perfluorohexyloctane (PFHO) ophthalmic solution (MIEBO™; Bausch + Lomb) is a preservative-free eye drop that has demonstrated the ability to form a long-lasting barrier that inhibits evaporation in preclinical studies. FDA approval of PFHO was based on results from 2 pivotal clinical trials (GOBI [NCT04139798] and MOJAVE [NCT04567329]) in patients with DED and clinical signs of MGD, which demonstrated consistent improvements in both signs and symptoms of DED (Karpecki et al., 2023; Vittitow et al., 2023). PFHO is the first and only FDA-approved eye drop that directly targets tear

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Adults ≥18 years of age
  • best corrected visual acuity (BCVA) of 20/100 or better
  • who have symptomatic DED will be recruited (SPEED ≥6)
  • Subjects will also be required to have a LWE score of 1.0 or greater to be included in the study.
  • Subjects will be required to discontinue contact lens wear throughout the study.

Exclusion criteria

  • known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome),
  • have a history of ocular surgery within the past 12 months, have a history of severe ocular trauma, active ocular infection or inflammation,
  • are currently using Accutane or ocular medications, or if they are pregnant or breast feeding.
  • Artificial tear use will be discontinued at least one week prior to enrollment. Subjects with a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study will be excluded.
  • Subjects that have had a physical meibomian gland treatment withing 1 month of enrollment (iLux, Lipiflow, etc.) will be excluded.
  • Subjects will not be allowed to use any eye drops beyond their assignment during the study.

Treatment and study plan

Preservative Free eye drop

Drug

Participants were required to use a lubricating eye drop

Primary outcomes

  1. VAS

    Time frame: 2-Months

    VAS on a scale from 0-100 will be reported at baseline, 2 weeks, 1 month and 2 months and recoreded to see if there is a reduction in the percentage of subjects with a reduction in VAS scores for eye dryness, eye scratchiness, eye gritty/sandy feeling, eye irritation/soreness, eye burning/stinging, tired eyes, and itchy eyes (0-100)

Sponsors and collaborators

Lead sponsor

Southern College of Optometry

Other

Collaborators

  • Alcon Research

Registry information

Official study title

Treating Lid Wiper Epitheliopathy With Perfluorohexyloctane

Acronym: TLWE

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 4, 2024
Registry last updated
Feb 25, 2025

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.

Published trials that share one or more normalized conditions with this study.