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.
- Clinical Trial
- Sclera and Episclera
- Treatment other
Statistics from Altmetric.com
Contributors Conception and design of study: JHK. Acquisition of data: JHK, EBS, VLP, JPD, DCG, EP, KMW. Analysis and/or interpretation of data: JH, MGM, GY, JHK. Drafting the manuscript: ECON, JHK. All authors contributed to the revision of the manuscript, and approved the version of the manuscript to be published.
Funding The study was funded by FDA R01FD3910 (JHK). Additional financial support and product donation were received from EyeGate Pharmaceuticals (JHK).
Disclaimer The funding organisations had no role in the design or conduct of this research.
Competing interests The study was secondarily funded and the study treatment was provided by EyeGate Pharma. JHK and JPD have served as consultants in the last 12 months for AbbVie.
Patient consent Not required.
Ethics approval Institutional Review Board at all participating institutions.
Provenance and peer review Not commissioned; externally peer reviewed.
If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.