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

Not Applicable

Suspended

• Conditions: Meibomian Gland Dysfunction
• Interventions: Device: Warm compress; Device: E>Eye IRPL

• Registration Number: NCT04920396
• Lead Sponsor: Aston University

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

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 Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-03
• Study Start: 2021-06-08
• Study First Posted: 2021-06-09
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2026-02-16
• Study Completion: 2026-12-16

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Warm compress	Warm compress	Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes
IRPL	E>Eye IRPL	Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45

Primary Outcome Measures

Name	Time	Method
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
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

Name	Time	Method
Tear volume	Change between baseline and day 75	Change in tear meniscus height measured in millimeters
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)
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)
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)

Trial Locations

Locations (1)

Market Mall Eye Clinic - Calgary, AB; 🇨🇦 Calgary, Alberta, Canada