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

Sponsor
Aston University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04920396
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
24.7
Anticipated Duration (Months)
2
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
N/A

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:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized allocation between treatmentsRandomized allocation between treatments
Masking:
Single (Investigator)
Masking Description:
Ocular assessment will be undertaken by a researcher masked to the participants treatment allocation
Primary Purpose:
Treatment
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

ArmIntervention/Treatment
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

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

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

    Sponsors and Collaborators

    • Aston University

    Investigators

    • Principal Investigator: James Wolffsohn, PhD, Aston University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    James Wolffsohn, associate Pro-Vice Chancellor, Aston University
    ClinicalTrials.gov Identifier:
    NCT04920396
    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:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 10, 2021