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EyeBag Effectiveness in Meibomian Gland Dysfunction (MGD)

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ClinicalTrials.gov Identifier: NCT01870180
Recruitment Status : Completed
First Posted : June 5, 2013
Last Update Posted : January 15, 2015
Sponsor:
Information provided by (Responsible Party):
Aston University

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.

Condition or disease Intervention/treatment Phase
Meibomian Gland Dysfunction Device: EyeBag Other: Placebo Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye
Study Start Date : May 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : December 2014

Arm Intervention/treatment
Experimental: EyeBag
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
fabric bag of beads which can be heated in a microwave
Other Name: MGDRx EyeBAg

Placebo Comparator: Placebo
Non-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated
Other: Placebo
Other Name: Non-Heated Eyebag




Primary Outcome Measures :
  1. Change in Ocular Symptoms [ Time Frame: Between baseline and 2 weeks ]
    Ocular symptomology: Ocular Surface Disease Index for right and left eyes

  2. Change in Tear Film Quality [ Time Frame: Between baseline and 2 weeks ]
    Non-invasive tear break up time: 3 measurements per eye


Secondary Outcome Measures :
  1. Change in Ocular redness [ Time Frame: Between baseline and 2 weeks ]
    Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured

  2. Change in Lipid layer thickness [ Time Frame: Between baseline and 2 weeks ]
    Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope

  3. Change in Meibomian Glands [ Time Frame: Between baseline and 2 weeks ]
    Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870180


Locations
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United Kingdom
Aston University
Birmingham, West Midlands, United Kingdom, B47ET
Sponsors and Collaborators
Aston University
Publications of Results:
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Responsible Party: Aston University
ClinicalTrials.gov Identifier: NCT01870180    
Other Study ID Numbers: 2013MGD
First Posted: June 5, 2013    Key Record Dates
Last Update Posted: January 15, 2015
Last Verified: January 2015
Keywords provided by Aston University:
Meibomian Glad Dysfunction
EyeBag
Hot Compress
Dry Eyes
Additional relevant MeSH terms:
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Meibomian Gland Dysfunction
Eyelid Diseases
Eye Diseases