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EyeBag Effectiveness in Meibomian Gland Dysfunction

Not Applicable
Completed
Conditions
Meibomian Gland Dysfunction
Interventions
Device: EyeBag
Other: Placebo
Registration Number
NCT01870180
Lead Sponsor
Aston University
Brief Summary

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

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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
18
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
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Exclusion Criteria

• Blepharitis

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
EyeBagEyeBagEye self-treated with heated eyebag in the morning and evening each day as per manufacturer's instructions (see http://www.eyebagcompany.com/how)
PlaceboPlaceboNon-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated
Primary Outcome Measures
NameTimeMethod
Change in Tear Film QualityBetween baseline and 2 weeks

Non-invasive tear break up time: 3 measurements per eye

Change in Ocular SymptomsBetween baseline and 2 weeks

Ocular symptomology: Ocular Surface Disease Index for right and left eyes

Secondary Outcome Measures
NameTimeMethod
Change in Lipid layer thicknessBetween baseline and 2 weeks

Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope

Change in Ocular rednessBetween baseline and 2 weeks

Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured

Change in Meibomian GlandsBetween baseline and 2 weeks

Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score

Trial Locations

Locations (1)

Aston University

🇬🇧

Birmingham, West Midlands, United Kingdom

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