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

Meibomian Gland Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04920396
• Other study ID #: Eeye03182021
• Status: Suspended
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: December 16, 2026

Study information

• Verified date: April 2024
• Source: Aston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.)

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 50
• Est. completion date: December 16, 2026
• Est. primary completion date: February 16, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Device:
• E>Eye IRPL
Regulated intense pulsed light therapy
• Warm 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

Locations

Country	Name	City	State
Canada	Market Mall Eye Clinic - Calgary, AB	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
Aston University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Tear volume	Change in tear meniscus height measured in millimeters	Change between baseline and day 75
Secondary	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