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 Quinones, 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 1 2018
Externally publishedYes

Fingerprint

dexamethasone 21-phosphate
Scleritis
Clinical Trials
Anterior Uveitis
Adrenal Cortex Hormones
Therapeutics
Sclera
Immunosuppressive Agents
Sample Size
Anti-Inflammatory Agents
Safety

Keywords

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

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience

Cite this

Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial. / O'Neil, Erin C.; Huang, Jiayan; Suhler, Eric B.; Dunn, James P.; Perez Quinones, Victor L; Gritz, David C.; McWilliams, Kathy; Peskin, Ellen; Ying, Gui Shuang; Bunya, Vatinee Y.; Maguire, Maureen G.; Kempen, John H.

In: British Journal of Ophthalmology, Vol. 102, No. 8, 01.08.2018, p. 1011-1013.

Research output: Contribution to journalArticle

O'Neil, EC, Huang, J, Suhler, EB, Dunn, JP, Perez Quinones, VL, Gritz, DC, McWilliams, K, Peskin, E, Ying, GS, Bunya, VY, Maguire, MG & Kempen, JH 2018, 'Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial', British Journal of Ophthalmology, vol. 102, no. 8, pp. 1011-1013. https://doi.org/10.1136/bjophthalmol-2017-311610
O'Neil, Erin C. ; Huang, Jiayan ; Suhler, Eric B. ; Dunn, James P. ; Perez Quinones, Victor L ; Gritz, David C. ; McWilliams, Kathy ; Peskin, Ellen ; Ying, Gui Shuang ; Bunya, Vatinee Y. ; Maguire, Maureen G. ; Kempen, John H. / Iontophoretic delivery of dexamethasone phosphate for non-infectious, non-necrotising anterior scleritis, dose-finding clinical trial. In: British Journal of Ophthalmology. 2018 ; Vol. 102, No. 8. pp. 1011-1013.
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