Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial

Erin C. O'Neil, Jiayan Huang, Eric B. Suhler, James P. Dunn, Victor L. Perez, David C. Gritz, Kathy McWilliams, Ellen Peskin, Gui Shuang Ying, Vatinee Y. Bunya, Maureen G. Maguire, John H. Kempen

Research output: Contribution to journalArticle

Abstract

Currently available treatment options for non-infectious scleritis, including non-steroidal anti-inflammatory drugs, systemic corticosteroids and immunosuppressive therapies, have both efficacy and side effect limitations. Iontophoretic delivery of corticosteroids has been demonstrated to be effective for anterior uveitis and represents a potential new approach to scleritis therapy. We hypothesised that iontophoretic delivery would provide effective and precise medication delivery to the sclera, while limiting systemic exposure and side effects. This first-in-human randomised, double-masked, dose-escalating study of iontophoretic administration of dexamethasone phosphate for scleritis suggests the treatment to be well tolerated and safe (within the limitations of the 18 patients sample size). There was a suggestion of efficacy in the lowest (1.2 mA/min at 0.4 mA) dose group (corresponding to the superficial location of scleritis compared with anterior uveitis), with 5/7 eyes meeting the primary efficacy outcome within 28 days. Our results suggest iontophoretic delivery of corticosteroids is a promising potential treatment for scleritis, with favourable safety and preliminary efficacy results in this phase 1 trial. Trial registration number NCT01059955.

Original languageEnglish (US)
Pages (from-to)1011-1013
Number of pages3
JournalBritish Journal of Ophthalmology
Volume102
Issue number8
DOIs
StatePublished - Aug 2018

Keywords

  • Clinical Trial
  • Dr.ugs
  • Sclera and Episclera
  • Treatment other

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

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    O'Neil, E. C., Huang, J., Suhler, E. B., Dunn, J. P., Perez, V. L., Gritz, D. C., McWilliams, K., Peskin, E., Ying, G. S., Bunya, V. Y., Maguire, M. G., & Kempen, J. H. (2018). Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial. British Journal of Ophthalmology, 102(8), 1011-1013. https://doi.org/10.1136/bjophthalmol-2017-311610