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

Study Overview
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Brief Summary
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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
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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.)

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

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: E>Eye IRPL
* Device: Warm compress


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized allocation between treatments
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IRPL<br>Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45 | Device: E>Eye IRPL<br>* Regulated intense pulsed light therapy<br>|
| Active Comparator: Warm compress<br>Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes | Device: Warm compress<br>* Fabric mask with anti-bacterial coating filled with BodyBeads® heated in a microwave for 30 seconds before application over the eyes for 5 minutes<br>* Other names: The Eye Doctor Mask;|

What is the study measuring?
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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 |