Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction

Aston University (Other)
Overall Status
Recruiting ID
Anticipated Duration (Months)
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is to evaluate the effectiveness of E>EYE intense regulated pulsed light (IRPL) treatment compared to the current standard of care using a daily warm compress

Condition or DiseaseIntervention/TreatmentPhase
  • Device: E>Eye IRPL
  • Device: Warm compress

Detailed Description

E-Eye is a medical device that has been specifically designed for treating dry eye syndrome due to meibomian gland dysfunction (MGD). This study is a prospective, single centred, interventional, randomized study assessing the efficacy and safety of E>EYE in the management of MGD (3 applications on days 0, 15 and 45, with a follow up 1 month later) compared to daily use of a warm compress over a period of 75 days.

The study will monitor the change in symptoms and signs of dry eye at each visit.)

Study Design

Study Type:
Anticipated Enrollment :
50 participants
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized allocation between treatmentsRandomized allocation between treatments
Single (Investigator)
Masking Description:
Ocular assessment will be undertaken by a researcher masked to the participants treatment allocation
Primary Purpose:
Official Title:
Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
Actual Study Start Date :
Jun 8, 2021
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

Experimental: IRPL

Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45

Device: E>Eye IRPL
Regulated intense pulsed light therapy

Active Comparator: Warm compress

Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes

Device: Warm compress
Fabric mask with anti-bacterial coating filled with BodyBeads® heated in a microwave for 30 seconds before application over the eyes for 5 minutes
Other Names:
  • The Eye Doctor Mask
  • Outcome Measures

    Primary Outcome Measures

    1. Symptoms of dry eye disease [Change between baseline and day 75]

      Change in Ocular Surface Disease Index (OSDI) questionnaire score from baseline to end of trial

    2. Tear film stability [Change between baseline and day 75]

      Change in non-invasive assessed tear film retention time from baseline to end of trial

    Secondary Outcome Measures

    1. Eye redness [Change between baseline and day 75]

      Change in ocular redness graded against standardised Efron grading scale (from 0 to 4, where lower is better)

    2. Meibomian gland patency [Change between baseline and day 75]

      Change in the number of glands expressing multiplied by the quality (on a 4 point standardised scale)

    3. Tear volume [Change between baseline and day 75]

      Change in tear meniscus height measured in millimeters

    4. Lipid layer thickness [Change between baseline and day 75]

      Change in white light interferometry pattern graded against the Guillon standardised categories (Open meshwork, closed meshwork, wave pattern, amorphous or colored fringes)

    Eligibility Criteria


    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Accepts Healthy Volunteers:
    Inclusion Criteria:
    • Willing and able to provide informed consent and participate in the required study visit

    • Subjects determined to have signs and symptoms of evaporative Dry Eye disease due to

    MGD, defined by the following:
    • OSDI score >13 and

    • NITBUT <= 10sec

    Exclusion Criteria:
    • No use of warm compresses, intense pulsed light therapy or other lid warming treatment in the past 6 Months

    • Patients with greater 75% meibomian gland loss

    • Presence of ocular pathology or systemic conditions other than previously diagnosed moderate or severe chronic dry eye and/or Sjogren's syndrome, that in the investigator's judgment may affect the testing for, or diagnosis of, dry eye if present

    • Use of prescribed ocular topical medication (e.g., anti-hypertensive, steroid, Cyclosporin A, antibiotic) within the last 24 hours

    • Artificial tear usage within 2 hours prior to study testing

    • Other invasive ocular diagnostic testing within 2 hours prior to study testing

    • Eye makeup present on the eye lid within 10 minutes prior to study testing

    Contacts and Locations


    SiteCityStateCountryPostal Code
    1Market Mall Eye Clinic - Calgary, ABCalgaryAlbertaCanadaAB T3A 0E2

    Sponsors and Collaborators

    • Aston University


    • Principal Investigator: James Wolffsohn, PhD, Aston University

    Study Documents (Full-Text)

    None provided.

    More Information


    None provided.
    Responsible Party:
    James Wolffsohn, associate Pro-Vice Chancellor, Aston University Identifier:
    Other Study ID Numbers:
    • Eeye03182021
    First Posted:
    Jun 9, 2021
    Last Update Posted:
    Jun 10, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Plan to Share IPD:
    Studies a U.S. FDA-regulated Drug Product:
    Studies a U.S. FDA-regulated Device Product:
    Product Manufactured in and Exported from the U.S.:
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2021