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

Meibomian Gland Dysfunction (MGD) Clinical Trial

— Hummingbird  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02284997
• Other study ID #: 20246
• Status: Completed
• Phase: N/A
• First received: November 3, 2014
• Last updated: May 28, 2015
• Start date: November 2014
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Clinical Research Ethics CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction (MGD)

Intervention

Device:
• MGDRx® EyeBag
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.

Locations

Country	Name	City	State
Canada	Centre for Contact Lens Research, University of Waterloo	Waterloo	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Waterloo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Meibomian gland score (MGS)	Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear	Baseline	No
Primary	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	8 weeks after baseline/treatment visit	No
Primary	Meibomian gland yielding liquid secretions (MGYLS)	Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.	Baseline	No
Primary	Meibomian gland yielding liquid secretions (MGYLS)	MGYLS is the number of glands with MGS grade 2 or higher.	8 weeks after baseline/treatment visit	No
Primary	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.	Baseline	No
Primary	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.	8 weeks after baseline/treatment visit	No