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Completed

NCT Number: NCT01870180

EyeBag Effectiveness in Meibomian Gland Dysfunction

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.

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Key information

Conditions

Meibomian Gland Dysfunction Dry Eye Syndromes Eye Diseases Eyelid Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aston University

Birmingham, West Midlands, B47ET, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EyeBag

Device

fabric bag of beads which can be heated in a microwave

Other names: MGDRx EyeBAg

Placebo

Other

Other names: Non-Heated Eyebag

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Aston University

Other

Registry information

Official study title

Investigating the Efficacy of the MGDRx EyeBag in Patients With Meibomian Gland Dysfunction Related Evaporative Dry Eye

Acronym: MGD

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Jun 5, 2013
Registry last updated
Jan 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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