search
Back to results

The Effect of an Eyelid Warming Device for the Management of Meibomian Gland Dysfunction (Hummingbird)

Primary Purpose

Meibomian Gland Dysfunction (MGD)

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MGDRx® EyeBag
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction (MGD)

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

  1. Is at least 17 years of age and has full legal capacity to volunteer;
  2. Has read and signed an information consent letter;
  3. Is willing and able to follow instructions and maintain the appointment schedule;
  4. OSDI score ≥ 23;
  5. Meibomian gland score of ≤ 9 (out of 15).
  6. Is on a stable dry eye regimen (if applicable) within the past 4 weeks, and is willing to maintain this regimen
  7. Agree to using MetricWire for online data entry
  8. Is not a contact lens wearer (Infrequent soft contact lens wearer is acceptable (wear contact lenses for maximum 2 days of the week)).

Exclusion Criteria:

A person will be excluded from the study if he/she:

  1. Is participating in any concurrent clinical or research study;
  2. Has any known hypersensitivity to flax, linseed or any of the other constituents of the EyeBag
  3. Has any known active* ocular disease and/or infection;
  4. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
  5. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
  6. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
  7. Is pregnant, lactating or planning a pregnancy at the time of enrolment, as determined verbally;
  8. Is aphakic;
  9. Has undergone refractive error surgery; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. An exception is made for lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Sites / Locations

  • Centre for Contact Lens Research, University of Waterloo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Participants will be instructed to use a warming MGDRx® EyeBag for minimum of 10 minutes, twice a day

No treatment

Outcomes

Primary Outcome Measures

Meibomian gland score (MGS)
Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
Meibomian gland score (MGS)
Eight weeks after treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
Meibomian gland yielding liquid secretions (MGYLS)
Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.
Meibomian gland yielding liquid secretions (MGYLS)
MGYLS is the number of glands with MGS grade 2 or higher.
Ocular Surface Disease Index Score (OSDI)
Prior to treatment (if applicable). The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.
Ocular Surface Disease Index Score (OSDI)
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.

Secondary Outcome Measures

Full Information

First Posted
November 3, 2014
Last Updated
May 28, 2015
Sponsor
University of Waterloo
search

1. Study Identification

Unique Protocol Identification Number
NCT02284997
Brief Title
The Effect of an Eyelid Warming Device for the Management of Meibomian Gland Dysfunction
Acronym
Hummingbird
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Waterloo

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Along the edge of the eyelids, there are glands (meibomian glands) that produce and deliver oils (meibum) onto the tear film. These oils serve to slow down the evaporation of tears. The meibomian glands may become obstructed due to change in meibum quality. When meibum thickens and solidifies, it plugs the gland openings and oils can no longer reach the tear film. The blockage of the glands is the primary cause of meibomian gland dysfunction (MGD), and may result in symptoms of dry eye (burning, stinging, grittiness, etc.). The typical treatment for MGD is a procedure called "warm compresses". It is a combination of applying heat and pressure to the eyelids for approximately 10 minutes to melt the meibum, unplug the gland openings, and allow oils to flow normally onto the tear film once again. One way to apply heat to the eyelids is by using the MGDRx® EyeBag. The EyeBag is microwaved for 30-40 seconds under full power, and is placed over the closed eyes for approximately 10 minutes. The eyes are gently massaged afterwards. The purpose of this study is to determine how effective the EyeBag is at improving MGD and dry eye symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction (MGD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Participants will be instructed to use a warming MGDRx® EyeBag for minimum of 10 minutes, twice a day
Arm Title
Control
Arm Type
No Intervention
Arm Description
No treatment
Intervention Type
Device
Intervention Name(s)
MGDRx® EyeBag
Intervention Description
Class 1 Medical Device, registered with the Medicines and Healthcare products Regulatory Agency. UK Patent: GB2421687B. The EyeBag is made of silk and 100% brushed black cotton and filled with flax / linseed. When heated, this device is intended to warm the eyelids. This melts the meibum and clears the meibum obstruction of the MGs.
Primary Outcome Measure Information:
Title
Meibomian gland score (MGS)
Description
Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
Time Frame
Baseline
Title
Meibomian gland score (MGS)
Description
Eight weeks after treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear
Time Frame
8 weeks after baseline/treatment visit
Title
Meibomian gland yielding liquid secretions (MGYLS)
Description
Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.
Time Frame
Baseline
Title
Meibomian gland yielding liquid secretions (MGYLS)
Description
MGYLS is the number of glands with MGS grade 2 or higher.
Time Frame
8 weeks after baseline/treatment visit
Title
Ocular Surface Disease Index Score (OSDI)
Description
Prior to treatment (if applicable). The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.
Time Frame
Baseline
Title
Ocular Surface Disease Index Score (OSDI)
Description
The OSDI is a questionnaire that consists of 12 questions about ocular irritation and the effect of dry eye on vision. For every question, participants check a score between 0 and 4, where 0 equals "none of the time" and 4 equals "all of the time". OSDI scores are calculated according to: OSDI = [(sum of scores for all questions answered)*100] / [(total number of questions answered)*4]. The possible range of the OSDI score is 0 to 100.
Time Frame
8 weeks after baseline/treatment visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A person is eligible for inclusion in the study if he/she: Is at least 17 years of age and has full legal capacity to volunteer; Has read and signed an information consent letter; Is willing and able to follow instructions and maintain the appointment schedule; OSDI score ≥ 23; Meibomian gland score of ≤ 9 (out of 15). Is on a stable dry eye regimen (if applicable) within the past 4 weeks, and is willing to maintain this regimen Agree to using MetricWire for online data entry Is not a contact lens wearer (Infrequent soft contact lens wearer is acceptable (wear contact lenses for maximum 2 days of the week)). Exclusion Criteria: A person will be excluded from the study if he/she: Is participating in any concurrent clinical or research study; Has any known hypersensitivity to flax, linseed or any of the other constituents of the EyeBag Has any known active* ocular disease and/or infection; Has a systemic condition that in the opinion of the investigator may affect a study outcome variable; Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable Has known sensitivity to the diagnostic pharmaceuticals to be used in the study; Is pregnant, lactating or planning a pregnancy at the time of enrolment, as determined verbally; Is aphakic; Has undergone refractive error surgery; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. An exception is made for lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyndon Jones, PhD
Organizational Affiliation
CCLR, University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Contact Lens Research, University of Waterloo
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2L 3G1
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

The Effect of an Eyelid Warming Device for the Management of Meibomian Gland Dysfunction

We'll reach out to this number within 24 hrs