Meibomian Gland Dysfunction
Conditions
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.)
Interventions
DEVICEE>Eye IRPL
Regulated intense pulsed light therapy
DEVICEWarm 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
Sponsors
Aston University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Ocular assessment will be undertaken by a researcher masked to the participants treatment allocation
Intervention model description
Randomized allocation between treatments
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORJames Wolffsohn, PhD
Aston University
Outcome results
None listed