Clinical trial NCT04920396: Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
Official title: Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Lead sponsor: Aston University
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized allocation between treatments
Primary purpose: TREATMENT

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.)

Eligibility criteria: 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

Primary outcomes:
measure: Symptoms of dry eye disease
timeFrame: Change between baseline and day 75
measure: Tear film stability
timeFrame: Change between baseline and day 75
Secondary outcomes:
measure: Eye redness
timeFrame: Change between baseline and day 75
measure: Meibomian gland patency
timeFrame: Change between baseline and day 75
measure: Tear volume
timeFrame: Change between baseline and day 75
measure: Lipid layer thickness
timeFrame: Change between baseline and day 75
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Market Mall Eye Clinic - Calgary, AB
state: Alberta
Study officials:
affiliation: Aston University
name: James Wolffsohn, PhD
role: PRINCIPAL_INVESTIGATOR
References: