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EyeBag Effectiveness in Meibomian Gland Dysfunction (MGD)

Primary Purpose

Meibomian Gland Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
EyeBag
Placebo
Sponsored by
Aston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Meibomian Gland Dysfunction focused on measuring Meibomian Glad Dysfunction, EyeBag, Hot Compress, Dry Eyes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Aston University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EyeBag

Placebo

Arm 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)

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

Outcomes

Primary Outcome Measures

Change in Ocular Symptoms
Ocular symptomology: Ocular Surface Disease Index for right and left eyes
Change in Tear Film Quality
Non-invasive tear break up time: 3 measurements per eye

Secondary Outcome Measures

Change in Ocular redness
Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured
Change in Lipid layer thickness
Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope
Change in Meibomian Glands
Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score

Full Information

First Posted
May 24, 2013
Last Updated
January 14, 2015
Sponsor
Aston University
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1. Study Identification

Unique Protocol Identification Number
NCT01870180
Brief Title
EyeBag Effectiveness in Meibomian Gland Dysfunction
Acronym
MGD
Official Title
Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aston University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meibomian Gland Dysfunction
Keywords
Meibomian Glad Dysfunction, EyeBag, Hot Compress, Dry Eyes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EyeBag
Arm Type
Experimental
Arm 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)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Non-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated
Intervention Type
Device
Intervention Name(s)
EyeBag
Other Intervention Name(s)
MGDRx EyeBAg
Intervention Description
fabric bag of beads which can be heated in a microwave
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Non-Heated Eyebag
Primary Outcome Measure Information:
Title
Change in Ocular Symptoms
Description
Ocular symptomology: Ocular Surface Disease Index for right and left eyes
Time Frame
Between baseline and 2 weeks
Title
Change in Tear Film Quality
Description
Non-invasive tear break up time: 3 measurements per eye
Time Frame
Between baseline and 2 weeks
Secondary Outcome Measure Information:
Title
Change in Ocular redness
Description
Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured
Time Frame
Between baseline and 2 weeks
Title
Change in Lipid layer thickness
Description
Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope
Time Frame
Between baseline and 2 weeks
Title
Change in Meibomian Glands
Description
Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score
Time Frame
Between baseline and 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Aston University
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B47ET
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
24997178
Citation
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.
Results Reference
result

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EyeBag Effectiveness in Meibomian Gland Dysfunction

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