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

• Published in: British journal of ophthalmology Vol. 102; no. 8; pp. 1011 - 1013
• Main Authors: O’Neil, Erin C, Huang, Jiayan, Suhler, Eric B, Dunn Jr, James P, Perez, Victor L, Gritz, David C, McWilliams, Kathy, Peskin, Ellen, Ying, Gui-shuang, Bunya, Vatinee Y, Maguire, Maureen G, Kempen, John H
• Format: Journal Article
• Language: English
• Published: England BMJ Publishing Group LTD 01.08.2018
• Subjects: Anterior Eye Segment; Clinical trials; Dexamethasone - administration & dosage; Dexamethasone - analogs & derivatives; Dose-Response Relationship, Drug; Double-Blind Method; Drug Delivery Systems; Drug dosages; Eye Infections - drug therapy; FDA approval; Female; Glucocorticoids - administration & dosage; Humans; Iontophoresis - methods; Male; Middle Aged; Necrosis - drug therapy; Ophthalmology; Pain; Randomized Controlled Trials as Topic; Scleritis - diagnosis; Scleritis - drug therapy; Steroids; Treatment Outcome; Drugs; Treatment other; Clinical Trial; Sclera and Episclera
• ISSN: 0007-1161; 1468-2079
• DOI: 10.1136/bjophthalmol-2017-311610

AbstractCurrently 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 numberNCT01059955.