EyeBag Effectiveness in Meibomian Gland Dysfunction (MGD)

Aston University

Status: Completed

Conditions: Meibomian Gland Dysfunction

Treatments: Other: Placebo; Device: EyeBag

Study type: Interventional

Funder types: Other

Identifiers

NCT01870180

2013MGD

Details and patient eligibility

About

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.

Full 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

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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18 participants in 2 patient groups, including a placebo group

EyeBag

Experimental group

Description:

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

Treatment:

Device: EyeBag

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo