The Effect of Eyelid Margin Debridement on Contact Lens Discomfort

NCT03311204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2020-03-20

No results posted yet for this study

Summary

In this study, clinical variables related to eyelids that potentially have an effect on contact lens discomfort will be investigated such as eyelid signs and secretions, eyelid sensitivity, eyelid microbiome, Demodex infestation and tear film properties. The main aim of this study is to understand the duration of efficacy of debridement of the eyelid margin and its impact on various eyelid signs (such as lid wiper epitheliopathy, lid-parallel conjunctival folds, eyelid sensitivity, meibomian gland morphology and meibum secretions, palpebral conjunctival reaction, eyelid microbiome and Demodex infestation, tear properties (both biophysical properties such as tear volume, tear meniscus height, tear evaporation, tear osmolarity and tear breakup time; and biochemical properties that are tear lipid analysis). To observe these variables, this study employs a cross-sectional design to study the effect of treatment at three instances, that is at baseline and two follow-up visits.

Conditions

  • Contact Lens Discomfort

Interventions

DEVICE

BlephEx

BlephEx is an instrument that contains a hand piece used to spin a medical grade micro-sponge along the edge of eyelids and lashes that helps in removing scurf and debris from eyelids and helps in exfoliating the lids. A new micro-sponge will be used for every subject to avoid cross-contamination. This procedure lasts for 6-8 mins.

OTHER

Lid Hygenix

Foam-based hypoallergenic cleanser used to clean eyelid margins is used as a control intervention for the study.

Sponsors & Collaborators

  • The University of New South Wales

    lead OTHER

Principal Investigators

  • Mark Willcox, D Sc · University of New South Wales

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-01-01
Completion
2018-02-01

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03311204 on ClinicalTrials.gov