Treating Lid Wiper Epitheliopathy

NCT06671041 | Completed Phase 4 FDA Drug

• 1 other identifier: IRB-2023-03-01AS
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Dry Eye; Visual Acuity

Keywords

Optometry; Dry Eye; Lens Wiper

Outcome Measures

Primary Outcomes (1)

• VAS

  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)

  2-Months

Study Arms (1)

Preservative-free eye drop

EXPERIMENTAL

Participants were assigned to use a preservative-free eye drop 4X a day

Drug: Preservative Free eye drop

Interventions

Preservative Free eye drop DRUG

Participants were required to use a lubricating eye drop

Preservative-free eye drop

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern College of Optometry: lead
• Alcon Research: collaborator

Study Sites (4)

Maitland Vision Center

Orlando, Florida, 32751, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Montaquila

Warwick, Rhode Island, 02888, United States

Location

The Southern College of Optometry

Memphis, Tennessee, 38104, United States

Location

Related Publications (1)

• Lievens C, Pucker AD, Franklin Q, Montaquila SM, Giedd B, Wesley G, Bromley M, Coker Z, Meyers J, Vianya-Estopa M. Investigating the Effect of Reducing the Signs and Symptoms of Lid Wiper Epitheliopathy in Patients With Dry Eye Disease With Perfluorohexyloctane. Curr Ther Res Clin Exp. 2025 Mar 20;102:100786. doi: 10.1016/j.curtheres.2025.100786. eCollection 2025.

  PMID: 40276144 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2024
• First Posted: November 4, 2024
• Study Start: May 27, 2024
• Primary Completion: August 14, 2024
• Study Completion: August 30, 2024
• Last Updated: February 25, 2025

Record last verified: 2024-10

Locations

US (4)