EyeBag Effectiveness in Meibomian Gland Dysfunction

NCT01870180 | Completed

• 1 other identifier: 2013MGD
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Meibomian Gland Dysfunction

Keywords

Meibomian Glad Dysfunction; EyeBag; Hot Compress; Dry Eyes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in Ocular redness

  Between baseline and 2 weeks

• Change in Lipid layer thickness

  Between baseline and 2 weeks

• Change in Meibomian Glands

  Between baseline and 2 weeks

Study Arms (2)

EyeBag

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

EyeBag DEVICE

fabric bag of beads which can be heated in a microwave

Also known as: MGDRx EyeBAg

EyeBag

Placebo OTHER

Also known as: Non-Heated Eyebag

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Blepharitis

Sponsors & Collaborators

• Aston University: lead

Study Sites (1)

Aston University

Birmingham, West Midlands, B47ET, United Kingdom

Location

Related Publications (1)

• Bilkhu PS, Naroo SA, Wolffsohn JS. Randomised masked clinical trial of the MGDRx EyeBag for the treatment of meibomian gland dysfunction-related evaporative dry eye. Br J Ophthalmol. 2014 Dec;98(12):1707-11. doi: 10.1136/bjophthalmol-2014-305220. Epub 2014 Jul 4.

  PMID: 24997178 RESULT

MeSH Terms

Conditions

Meibomian Gland Dysfunction; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2013
• First Posted: June 5, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2014
• Last Updated: January 15, 2015

Record last verified: 2015-01

Locations

GB (1)