EyeBag Effectiveness in Meibomian Gland Dysfunction

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-12-31

Brief Summary

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Meibomian gland dysfunction (MGD) is a common condition that causes the secretion from meibomian glands in the eyelids to become blocked. Normally, the secretion helps to maintain a healthy tear film. In MGD, the tear film becomes unstable and often causes dry eye symptoms. Treatments often involve gently warming the eyelids to melt this blockage which prevents tears from spreading over the eye. Although there has been some research on application of heat with warm moist flannels, the Eye Bags potentially offers a simpler and more effective method of applying heat to the eyelids. This study will test the efficiency of these eyelid warming devices over a period of two weeks use in one eye compared to the other non-treated eye.

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Detailed Description

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Study Design

Contralateral treatment study Randomised eye treated with heated eyebag in the morning and evening each day as per manufacturer's instructions Other eye acts as control with room temperature eyebag overlaid in same manner as treatment eye Investigators masked SMS messaging twice a day for 14 days to remind patients to use eyebag and collect 0-10 comfort score

Conditions

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Meibomian Gland Dysfunction

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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EyeBag

Eye self-treated with heated eyebag in the morning and evening each day as per manufacturer's instructions (see http://www.eyebagcompany.com/how)

Group Type EXPERIMENTAL

EyeBag

Intervention Type DEVICE

fabric bag of beads which can be heated in a microwave

Placebo

Non-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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EyeBag

fabric bag of beads which can be heated in a microwave

Intervention Type DEVICE

Placebo

Intervention Type OTHER

Other Intervention Names

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MGDRx EyeBAg Non-Heated Eyebag

Eligibility Criteria

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Inclusion Criteria

* 18 or over
* Have otherwise healthy eyes
* Are prepared not to wear contact lens for the 2 weeks of the trial
* Have a NITBUT \<10s
* OSDI score: greater than or equal to 12
* Symptom frequency at least "some of the time"
* Presence of cloudy fluid expressed from at least 1 of the central 8 glands on the lower/upper lid AND/OR presence of poor expressibility from at least 2-3 of the central 8 glands on the lower lid