EyeBag Effectiveness in Meibomian Gland Dysfunction

Meibomian Gland Dysfunction Clinical Trial

— MGD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01870180
• Other study ID #: 2013MGD
• Status: Completed
• Phase: N/A
• First received: May 24, 2013
• Last updated: January 14, 2015
• Start date: May 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Aston University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2014
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Meibomian Gland Dysfunction

Intervention

Device:
• EyeBag
fabric bag of beads which can be heated in a microwave

Other:
• Placebo

Locations

Country	Name	City	State
United Kingdom	Aston University	Birmingham	West Midlands

Sponsors (1)

Lead Sponsor	Collaborator
Aston University

Country where clinical trial is conducted

United Kingdom, 

References & 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 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Ocular Symptoms	Ocular symptomology: Ocular Surface Disease Index for right and left eyes	Between baseline and 2 weeks	No
Primary	Change in Tear Film Quality	Non-invasive tear break up time: 3 measurements per eye	Between baseline and 2 weeks	No
Secondary	Change in Ocular redness	Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured	Between baseline and 2 weeks	No
Secondary	Change in Lipid layer thickness	Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope	Between baseline and 2 weeks	No
Secondary	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	No