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

Aston University

Status: Suspended

Conditions: Meibomian Gland Dysfunction

Treatments: Device: E>Eye IRPL; Device: Warm compress

Study type: Interventional

Funder types: Other

Identifiers

NCT04920396

Eeye03182021

Details and patient eligibility

About

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

Full 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.)

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

IRPL

Experimental group

Description:

Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45

Treatment:

Device: E>Eye IRPL

Warm compress

Active Comparator group

Description:

Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes

Treatment:

Device: Warm compress