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

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

Study Overview

• Status: Suspended
• Conditions: Meibomian Gland Dysfunction
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, AB T3A 0E2
      • Market Mall Eye Clinic - Calgary, AB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms of dry eye disease	Change in Ocular Surface Disease Index (OSDI) questionnaire score from baseline to end of trial	Change between baseline and day 75
Tear film stability	Change in non-invasive assessed tear film retention time from baseline to end of trial	Change between baseline and day 75

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eye redness	Change in ocular redness graded against standardised Efron grading scale (from 0 to 4, where lower is better)	Change between baseline and day 75
Meibomian gland patency	Change in the number of glands expressing multiplied by the quality (on a 4 point standardised scale)	Change between baseline and day 75
Tear volume	Change in tear meniscus height measured in millimeters	Change between baseline and day 75
Lipid layer thickness	Change in white light interferometry pattern graded against the Guillon standardised categories (Open meshwork, closed meshwork, wave pattern, amorphous or colored fringes)	Change between baseline and day 75

Collaborators and Investigators

• Sponsor: Aston University
• Investigators: Principal Investigator: James Wolffsohn, PhD, Aston University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2021
• Primary Completion (Estimated): February 16, 2026
• Study Completion (Estimated): December 16, 2026

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: June 3, 2021
• First Posted (Actual): June 9, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction
• Other Study ID Numbers: Eeye03182021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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