Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

EyeBag Effectiveness in Meibomian Gland Dysfunction (MGD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 24, 2013
First Posted Date  ICMJE June 5, 2013
Last Update Posted Date January 15, 2015
Study Start Date  ICMJE May 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2013)
  • Change in Ocular Symptoms [ Time Frame: Between baseline and 2 weeks ]
    Ocular symptomology: Ocular Surface Disease Index for right and left eyes
  • Change in Tear Film Quality [ Time Frame: Between baseline and 2 weeks ]
    Non-invasive tear break up time: 3 measurements per eye
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2013)
  • Change in Ocular redness [ Time Frame: Between baseline and 2 weeks ]
    Ocular hyperaemia: limbal and temporal conjunctiva for both eyes, images captured
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE EyeBag Effectiveness in Meibomian Gland Dysfunction
Official Title  ICMJE Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Meibomian Gland Dysfunction
Intervention  ICMJE
  • Device: EyeBag
    fabric bag of beads which can be heated in a microwave
    Other Name: MGDRx EyeBAg
  • Other: Placebo
    Other Name: Non-Heated Eyebag
Study Arms  ICMJE
  • 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)
    Intervention: Device: EyeBag
  • Placebo Comparator: Placebo
    Non-heated EyeBAG: As with eyebag arm but second eyebag applied on other eye at same time BUT not heated
    Intervention: Other: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 14, 2015)
18
Original Estimated Enrollment  ICMJE
 (submitted: June 3, 2013)
20
Actual Study Completion Date  ICMJE December 2014
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01870180
Other Study ID Numbers  ICMJE 2013MGD
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Aston University
Study Sponsor  ICMJE Aston University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Aston University
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP