Back to resultsIntense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
Primary Purpose
Meibomian Gland Dysfunction
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
E>Eye IRPL
Warm compress
Sponsored by
About this trial
This is an interventional treatment trial for Meibomian Gland Dysfunction
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
Sites / Locations
- Market Mall Eye Clinic - Calgary, ABRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IRPL
Warm compress
Arm Description
Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45
Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes
Outcomes
Primary Outcome Measures
Symptoms of dry eye disease
Change in Ocular Surface Disease Index (OSDI) questionnaire score from baseline to end of trial
Tear film stability
Change in non-invasive assessed tear film retention time from baseline to end of trial
Secondary Outcome Measures
Eye redness
Change in ocular redness graded against standardised Efron grading scale (from 0 to 4, where lower is better)
Meibomian gland patency
Change in the number of glands expressing multiplied by the quality (on a 4 point standardised scale)
Tear volume
Change in tear meniscus height measured in millimeters
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04920396
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 8, 2021 (Actual)
Primary Completion Date
February 16, 2024 (Anticipated)
Study Completion Date
February 16, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aston University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized allocation between treatments
Masking
Investigator
Masking Description
Ocular assessment will be undertaken by a researcher masked to the participants treatment allocation
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IRPL
Arm Type
Experimental
Arm Description
Three treatments with IRPL (manufacturer: E-Swin, France) on days 0, 15 and 45
Arm Title
Warm compress
Arm Type
Active Comparator
Arm Description
Daily use of a warm compress (manufacturer: The Eye Doctor, UK) with Sterileyes® twice a day for 5 minutes
Intervention Type
Device
Intervention Name(s)
E>Eye IRPL
Intervention Description
Regulated intense pulsed light therapy
Intervention Type
Device
Intervention Name(s)
Warm compress
Other Intervention Name(s)
The Eye Doctor Mask
Intervention Description
Fabric mask with anti-bacterial coating filled with BodyBeads® heated in a microwave for 30 seconds before application over the eyes for 5 minutes
Primary Outcome Measure Information:
Title
Symptoms of dry eye disease
Description
Change in Ocular Surface Disease Index (OSDI) questionnaire score from baseline to end of trial
Time Frame
Change between baseline and day 75
Title
Tear film stability
Description
Change in non-invasive assessed tear film retention time from baseline to end of trial
Time Frame
Change between baseline and day 75
Secondary Outcome Measure Information:
Title
Eye redness
Description
Change in ocular redness graded against standardised Efron grading scale (from 0 to 4, where lower is better)
Time Frame
Change between baseline and day 75
Title
Meibomian gland patency
Description
Change in the number of glands expressing multiplied by the quality (on a 4 point standardised scale)
Time Frame
Change between baseline and day 75
Title
Tear volume
Description
Change in tear meniscus height measured in millimeters
Time Frame
Change between baseline and day 75
Title
Lipid layer thickness
Description
Change in white light interferometry pattern graded against the Guillon standardised categories (Open meshwork, closed meshwork, wave pattern, amorphous or colored fringes)
Time Frame
Change between baseline and day 75
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
James Wolffsohn, PhD
Phone
07833049245
Email
j.s.w.wolffsohn@aston.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Wolffsohn, PhD
Organizational Affiliation
Aston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Market Mall Eye Clinic - Calgary, AB
City
Calgary
State/Province
Alberta
ZIP/Postal Code
AB T3A 0E2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Saleel Jivraj, PhD
Phone
+1 587-324-2824
Email
jivrajs1@aston.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Intense Regulated Pulsed Light Vs Standard of Care for the Treatment of Meibomian Gland Dysfunction
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