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

NCT ID: NCT02284997

Last Updated: 2015-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Meibomian Gland Dysfunction (MGD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

MGDRx® EyeBag

Intervention Type 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.

Control

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Waterloo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lyndon Jones, PhD

Role: PRINCIPAL_INVESTIGATOR

CCLR, University of Waterloo

Locations

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Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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20246

Identifier Type: -

Identifier Source: org_study_id