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

NCT04920396 | Suspended

• 1 other identifier: Eeye03182021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Meibomian Gland Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Eye redness

  Change between baseline and day 75

• Meibomian gland patency

  Change between baseline and day 75

• Tear volume

  Change between baseline and day 75

• Lipid layer thickness

  Change between baseline and day 75

Study Arms (2)

IRPL

EXPERIMENTAL

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

Device: E>Eye IRPL

Warm compress

ACTIVE COMPARATOR

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

Device: Warm compress

Interventions

E>Eye IRPL DEVICE

Regulated intense pulsed light therapy

IRPL

Warm compress 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

Also known as: The Eye Doctor Mask

Warm compress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aston University: lead

Study Sites (1)

Market Mall Eye Clinic - Calgary, AB

Calgary, Alberta, AB T3A 0E2, Canada

Location

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Study Officials

• James Wolffsohn, PhD

  Aston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Ocular assessment will be undertaken by a researcher masked to the participants treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Randomized allocation between treatments

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 9, 2021
• Study Start: June 8, 2021
• Primary Completion: February 16, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)