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

NCT02284997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2015-05-29

No results posted yet for this study

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.

Conditions

  • Meibomian Gland Dysfunction (MGD)

Interventions

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.

Sponsors & Collaborators

  • University of Waterloo

    lead OTHER

Principal Investigators

  • Lyndon Jones, PhD · CCLR, University of Waterloo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Canada

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02284997 on ClinicalTrials.gov