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EyeBag Effectiveness in Meibomian Gland Dysfunction

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01870180
Acronym
MGD
Enrollment
18
Registered
2013-06-05
Start date
2013-05-31
Completion date
2014-12-31
Last updated
2015-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Meibomian Gland Dysfunction

Keywords

Meibomian Glad Dysfunction, EyeBag, Hot Compress, Dry Eyes

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

Interventions

DEVICEEyeBag

fabric bag of beads which can be heated in a microwave

OTHERPlacebo

Sponsors

Aston University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Ocular SymptomsBetween baseline and 2 weeksOcular symptomology: Ocular Surface Disease Index for right and left eyes
Change in Tear Film QualityBetween baseline and 2 weeksNon-invasive tear break up time: 3 measurements per eye

Secondary

MeasureTime frameDescription
Change in Ocular rednessBetween baseline and 2 weeksOcular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured
Change in Lipid layer thicknessBetween baseline and 2 weeksTear film lipid layer thickness: for right and left eyes, images captured with Tearscope
Change in Meibomian GlandsBetween baseline and 2 weeksMeibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026