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EyeBag Effectiveness in Meibomian Gland Dysfunction (MGD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Aston University
Sponsor:
Information provided by (Responsible Party):
Aston University
ClinicalTrials.gov Identifier:
NCT01870180
First received: May 24, 2013
Last updated: June 3, 2013
Last verified: June 2013
  Purpose

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 Intervention
Meibomian Gland Dysfunction
Device: EyeBag
Other: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye

Further study details as provided by Aston University:

Primary Outcome Measures:
  • Change in Ocular Symptoms [ Time Frame: Between baseline and 2 weeks ] [ Designated as safety issue: No ]
    Ocular symptomology: Ocular Surface Disease Index for right and left eyes

  • Change in Tear Film Quality [ Time Frame: Between baseline and 2 weeks ] [ Designated as safety issue: No ]
    Non-invasive tear break up time: 3 measurements per eye


Secondary Outcome Measures:
  • Change in Ocular redness [ Time Frame: Between baseline and 2 weeks ] [ Designated as safety issue: No ]
    Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured

  • Change in Lipid layer thickness [ Time Frame: Between baseline and 2 weeks ] [ Designated as safety issue: No ]
    Tear film lipid layer thickness: for right and left eyes, images captured with Tearscope

  • Change in Meibomian Glands [ Time Frame: Between baseline and 2 weeks ] [ Designated as safety issue: No ]
    Meibography: for right and left eyes, images captured using Keratograph 5 leading to change in area score


Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01870180

Contacts
Contact: Paramdeep Bilkhu, BSc +44(0)1212045035 ext 5035 bilkhups@aston.ac.uk

Locations
United Kingdom
Aston University Recruiting
Birmingham, West Midlands, United Kingdom, B47ET
Contact: Paramdeep Bilkhu, BSc    +44(0)1212045035 ext 5035    bilkhups@aston.ac.uk   
Sponsors and Collaborators
Aston University
  More Information

No publications provided

Responsible Party: Aston University
ClinicalTrials.gov Identifier: NCT01870180     History of Changes
Other Study ID Numbers: 2013MGD
Study First Received: May 24, 2013
Last Updated: June 3, 2013
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Aston University:
Meibomian Glad Dysfunction
EyeBag
Hot Compress
Dry Eyes

ClinicalTrials.gov processed this record on November 20, 2014