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MGD: EyeBag Effectiveness in Meibomian Gland Dysfunction

Sponsor
Aston University (Other)
Overall Status
Completed
CT.gov ID
NCT01870180
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
19
Duration (Months)
0.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: EyeBag
  • Other: Placebo
 N/A

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

Study Design

Study Type:
Interventional
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 1, 2013
Actual Primary Completion Date :
Jul 1, 2013
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

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 Names:
  • 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 Names:
  • Non-Heated Eyebag

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Ocular Symptoms [Between baseline and 2 weeks]

      Ocular symptomology: Ocular Surface Disease Index for right and left eyes

    2. Change in Tear Film Quality [Between baseline and 2 weeks]

      Non-invasive tear break up time: 3 measurements per eye

    Secondary Outcome Measures

    1. Change in Ocular redness [Between baseline and 2 weeks]

      Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured

    2. Change in Lipid layer thickness [Between baseline and 2 weeks]

      Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope

    3. Change in Meibomian Glands [Between baseline and 2 weeks]

      Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aston University Birmingham West Midlands United Kingdom B47ET

    Sponsors and Collaborators

    • Aston University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Aston University
    ClinicalTrials.gov Identifier:
    NCT01870180
    Other Study ID Numbers:
    • 2013MGD
    First Posted:
    Jun 5, 2013
    Last Update Posted:
    Jan 15, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Aston University
    Meibomian Glad Dysfunction
    EyeBag
    Hot Compress
    Dry Eyes
    Additional relevant MeSH terms:
    Meibomian Gland Dysfunction

    Study Results

    No Results Posted as of Jan 15, 2015