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Completed

NCT Number: NCT02284997

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

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.

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Key information

Conditions

Meibomian Gland Dysfunction (MGD) Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MGDRx® EyeBag

Device

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 outcomes

  1. Meibomian gland score (MGS)

    Time frame: Baseline

    Prior to treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear

  2. Meibomian gland score (MGS)

    Time frame: 8 weeks after baseline/treatment visit

    Eight weeks after treatment (if applicable). Scale 0-3. 0: no secretion, 1: inspissated (toothpaste), 2: cloudy with debris, 3: clear

  3. Meibomian gland yielding liquid secretions (MGYLS)

    Time frame: Baseline

    Prior to treatment (if applicable). MGYLS is the number of glands with MGS grade 2 or higher.

  4. Meibomian gland yielding liquid secretions (MGYLS)

    Time frame: 8 weeks after baseline/treatment visit

    MGYLS is the number of glands with MGS grade 2 or higher.

  5. Ocular Surface Disease Index Score (OSDI)

    Time frame: Baseline

    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.

  6. Ocular Surface Disease Index Score (OSDI)

    Time frame: 8 weeks after baseline/treatment visit

    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.

Sponsors and collaborators

Lead sponsor

University of Waterloo

Other

Registry information

Acronym: Hummingbird

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2014
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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