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Randomised controlled trial
Original article
Randomised masked trial of the clinical safety and tolerability of MGO Manuka Honey eye cream for the management of blepharitis
  1. Jennifer P Craig1,
  2. Michael T M Wang1,
  3. Kalaivarny Ganesalingam1,
  4. Ilva D Rupenthal1,
  5. Simon Swift2,
  6. Chee Seang Loh1,
  7. Leah Te Weehi1,
  8. Isabella M Y Cheung1,
  9. Grant A Watters1
  1. 1 Department of Ophthalmology, New Zealand National Eye Centre, The University of Auckland, Auckland, New Zealand
  2. 2 Department of Molecular Medicine and Pathology, The University of Auckland, Auckland, New Zealand
  1. Correspondence to Associate Professor Jennifer P Craig; jp.craig{at}auckland.ac.nz

Abstract

Objective To assess the clinical safety and tolerability of a novel MGO Manuka Honey microemulsion (MHME) eye cream for the management of blepharitis in human subjects.

Methods and analysis Twenty-five healthy subjects were enrolled in a prospective, randomised, paired-eye, investigator-masked trial. The MHME eye cream (Manuka Health New Zealand) was applied to the closed eyelids of one eye (randomised) overnight for 2 weeks. LogMAR visual acuity, eyelid irritation symptoms, ocular surface characteristics and tear film parameters were assessed at baseline, day 7 and day 14. Expression of markers of ocular surface inflammation (matrix metalloproteinase-9 and interleukin-6) and goblet cell function (MUC5AC) were quantified using impression cytology at baseline and day 14.

Results There were no significant changes in visual acuity, eyelid irritation symptoms, ocular surface characteristics, tear film parameters and inflammatory marker expression during the 2-week treatment period in treated and control eyes (all p>0.05), and measurements did not differ significantly between eyes (all p>0.05). No major adverse events were reported. Two subjects experienced transient ocular stinging, presumably due to migration of the product into the eye, which resolved following aqueous irrigation.

Conclusion The MHME eye cream application was found to be well tolerated in healthy human subjects and was not associated with changes in visual acuity, ocular surface characteristics, tear film parameters, expression of markers of inflammation or goblet cell function. The findings support future clinical efficacy trials in patients with blepharitis.

Trial registration number ACTRN12616000540415

  • blepharitis
  • Manuka honey
  • methylglyoxal
  • conjunctival impression cytology

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjophth-2016-000066

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    Footnotes

    • Contributors All authors took an active part in the design, conduct, data analysis and publication drafting and approval.

    • Funding Manuka Health New Zealand Ltd provided unrestricted research grant support.

    • Competing interests None declared.

    • Ethics approval The University of Auckland Human Participants Ethics Committee.

    • Provenance and peer review Commissioned; externally peer reviewed.

    • Data sharing statement All data relating to the study is published. Any requests for data can be made to the corresponding author. Any queries relating to the MGO Manuka Honey microemulsion can be made to Manuka Health New Zealand Ltd.