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.


Background/aims: To investigate the efficacy and safety of the MGDRx EyeBag (The Eyebag Company, Halifax, UK) eyelid warming device.

Methods: Twenty-five patients with confirmed meibomian gland dysfunction (MGD)-related evaporative dry eye were enrolled into a randomised, single masked, contralateral clinical trial. Test eyes received a heated device; control eyes a non-heated device for 5 min twice a day for 2 weeks. Efficacy (ocular symptomology, non-invasive break-up time, lipid layer thickness, osmolarity, meibomian gland dropout and function) and safety (visual acuity, corneal topography, conjunctival hyperaemia and staining) measurements were taken at baseline and follow-up. Subsequent patient device usage and ocular comfort was ascertained at 6 months.

Results: Differences between test and control eyes at baseline were not statistically significant for all measurements (p>0.05). After 2 weeks, statistically significant improvements occurred in all efficacy measurements in test eyes (p<0.05). Visual acuity and corneal topography were unaffected (p>0.05). All patients maintained higher ocular comfort after 6 months (p<0.05), although the benefit was greater in those who continued usage 1-8 times a month (p<0.001).

Conclusions: The MGDRx EyeBag is a safe and effective device for the treatment of MGD-related evaporative dry eye. Subjective benefit lasts at least 6 months, aided by occasional retreatment.

Trial registration number: NCT01870180.

Keywords: Ocular surface; Tears; Treatment other.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Corneal Topography
  • Dry Eye Syndromes / complications
  • Dry Eye Syndromes / therapy*
  • Eyelid Diseases / etiology
  • Eyelid Diseases / therapy*
  • Female
  • Humans
  • Hyperthermia, Induced / adverse effects
  • Hyperthermia, Induced / instrumentation*
  • Lipid Metabolism
  • Male
  • Meibomian Glands
  • Osmolar Concentration
  • Single-Blind Method
  • Tears / chemistry
  • Tears / metabolism
  • Treatment Outcome
  • Visual Acuity / physiology
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT01870180