EyeBag Effectiveness in Meibomian Gland Dysfunction

Study Overview
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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.

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

Official Title
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Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye

Conditions
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Meibomian Gland Dysfunction

Intervention / Treatment
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* Device: EyeBag
* Other: Placebo


Participation Criteria
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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 Exclusion Criteria: • Blepharitis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EyeBag<br>Eye self-treated with heated eyebag in the morning and evening each day as per manufacturer's instructions (see http://www.eyebagcompany.com/how) | Device: EyeBag<br>* fabric bag of beads which can be heated in a microwave<br>* Other names: MGDRx EyeBAg;|
| Placebo Comparator: Placebo<br>Non-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated | Other: Placebo<br> <br> * Other names: Non-Heated Eyebag;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ocular Symptoms | Ocular symptomology: Ocular Surface Disease Index for right and left eyes | Between baseline and 2 weeks | 
| Change in Tear Film Quality | Non-invasive tear break up time: 3 measurements per eye | Between baseline and 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ocular redness | Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured | Between baseline and 2 weeks | 
| Change in Lipid layer thickness | Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope | Between baseline and 2 weeks | 
| Change in Meibomian Glands | Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score | Between baseline and 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meibomian Glad Dysfunction, EyeBag, Hot Compress, Dry Eyes