June 2022
Volume 63, Issue 7
Open Access
ARVO Annual Meeting Abstract  |   June 2022
The effect of a novel selenium disulphide-containing topical treatment on ocular signs in individuals with meibomian gland dysfunction
Author Affiliations & Notes
  • Jacqueline Tan
    School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia
  • Tianni Jia
    School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia
  • Charles Bosworth
    Azura Ophthalmics, Arizona, United States
  • Nancy Briggs
    School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia
  • Marc T Gleeson
    Azura Ophthalmics, Arizona, United States
  • Fiona Stapleton
    School of Optometry and Vision Science, University of New South Wales, Sydney, New South Wales, Australia
  • Footnotes
    Commercial Relationships   Jacqueline Tan Azura Ophthalmics, Code F (Financial Support); Tianni Jia None; Charles Bosworth Azura Ophthalmics, Code I (Personal Financial Interest); Nancy Briggs None; Marc Gleeson Azura Ophthalmics, Code I (Personal Financial Interest); Fiona Stapleton Azura Ophthalmics, Code F (Financial Support)
  • Footnotes
    Support  Investigator Initiated Trial Grant from Azura Ophthalmics
Investigative Ophthalmology & Visual Science June 2022, Vol.63, 1535 – A0260. doi:
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    • Get Citation

      Jacqueline Tan, Tianni Jia, Charles Bosworth, Nancy Briggs, Marc T Gleeson, Fiona Stapleton; The effect of a novel selenium disulphide-containing topical treatment on ocular signs in individuals with meibomian gland dysfunction. Invest. Ophthalmol. Vis. Sci. 2022;63(7):1535 – A0260.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : A novel topical ointment AZR-MD-001, containing selenium disulphide designed to treat meibomian gland hyperkeratinisation, has been shown to improve symptoms and signs of meibomian gland dysfunction (MGD). This study evaluated the effect of biweekly dosing on tear film parameters in a double-masked, vehicle-controlled, randomized, parallel group clinical trial in individuals with MGD.

Methods : Participants with evidence of MGD (Meibomian Gland Secretion score [MGS] ≤12 for 15 glands of the lower lid), and signs and symptoms of dry eye (fluorescein tear break-up time [FBUT] <10 seconds and Ocular Surface Disease Index [OSDI] score >12) in both eyes were enrolled. Participants were randomly assigned to receive either the test AZR-MD-001 1% or control ointment to the lower eyelid margin (NCT04314362). Tear evaporation rate (TER), lipid layer thickness (LLT), non-invasive keratograph tear break-up time (NIKBUT), tear meniscus height (TMH) and FBUT were measured at baseline and after 2, 4, 6 weeks and 3 months of treatment. Differences between active and vehicle were analyzed relative to baseline using ANCOVA.

Results : Twenty-two participants (7 males and 15 females, aged 44.8 ± 17.7 years, average baseline OSDI 37.1 ± 14.2) completed the study. Compared with the vehicle group, a significantly greater improvement (reduction) in TER was observed in the active treatment group at the 2-week visit (mean treatment difference ± standard error: -30.2 ± 14.8gm-2h, p=0.044). A corresponding reduction (worsening) in FBUT was also observed in the vehicle group at the 2-week visit compared to the treatment group (1.3 ± 0.6 sec, p=0.037). The number of meibomian glands yielding liquid secretion was significantly higher in the active group at 3 months (1.8 ± 0.9, p = 0.043), whereas the improvement in MGS score didn’t quite reach statistical significance (5.6 ± 2.9, p = 0.056). No differences were observed for change from baseline between the two groups for OSDI score, LLT, NIKBUT or TMH at any visit.

Conclusions : Measurable improvements in tear film stability were observed with use of the novel topical ointment containing selenium disulphide. Further work to understand the potential longer-term benefits of the ointment, including any changes to meibomian gland morphology associated with functional improvements, is warranted.

This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.

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