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

NCT ID: NCT04920396

Last Updated: 2024-04-23

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-08
• Study Completion Date: 2026-12-16

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.)

Conditions

Meibomian Gland Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

IRPL

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

Group Type: EXPERIMENTAL

E>Eye IRPL

Intervention Type: DEVICE

Regulated intense pulsed light therapy

Warm compress

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

Group Type: ACTIVE_COMPARATOR

Warm compress

Intervention Type: DEVICE

Fabric mask with anti-bacterial coating filled with BodyBeads® heated in a microwave for 30 seconds before application over the eyes for 5 minutes

Interventions

E>Eye IRPL

Regulated intense pulsed light therapy

Intervention Type: DEVICE

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

Intervention Type: DEVICE

Other Intervention Names

The Eye Doctor Mask

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aston University

OTHER

Sponsor Role: lead

Responsible Party

James Wolffsohn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Wolffsohn, PhD

Role: PRINCIPAL_INVESTIGATOR

Aston University

Locations

Market Mall Eye Clinic - Calgary, AB

Calgary, Alberta, Canada

Countries

Canada

Other Identifiers

Eeye03182021

Identifier Type: -

Identifier Source: org_study_id