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Efficacy and safety of 0.1% ciclosporin A cationic emulsion in dry eye disease: A pooled analysis of two double-masked, randomised, vehicle-controlled phase III clinical studies

Lookup NU author(s): Professor Francisco FigueiredoORCiD



This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License (CC BY-NC 4.0).


© 2019 Article author(s). Background/aim To assess the treatment effect of 0.1% ciclosporin A cationic emulsion (CsA CE) versus vehicle on signs/symptoms of dry eye disease (DED) in various subgroups (moderate-to-severe DED/severe DED/Sjögren's syndrome (SS)/SS with severe DED). Methods Pooled data were analysed from two similar phase III studies: SICCANOVE (moderate-to-severe DED) and SANSIKA (severe DED with severe keratitis). In both studies, patients aged ≥18 years received CsA CE 0.1% (n=395) or vehicle (n=339) once daily for 6 months. A composite responder efficacy endpoint (corneal fluorescein staining-Ocular Surface Disease Index (CFS-OSDI) at month 6) was used to evaluate the efficacy of CsA CE in alleviating signs/symptoms of DED (response defined as improvement of ≥2 grades in CFS and ≥30% in OSDI (baseline to month 6)). Human leucocyte antigen-DR (HLA-DR) conjunctival expression was used as a biomarker of ocular surface inflammation. Results CsA CE-treated patients were significantly more likely to be CFS-OSDI responders than vehicle-treated patients in the overall (OR 1.66, 95% CI 1.11 to 2.50; P=0.015), severe DED (1.80, 1.04 to 3.19; P=0.038) and SS with severe DED (3.37, 1.20 to 11.19; P=0.030) populations. The difference was not significant for CsA CE versus vehicle for the overall Sjögren's population (OR 1.77, CI 0.89 to 3.66; P=0.109). CsA CE also significantly reduced median HLA-DR expression versus vehicle at 6 months (P=0.002). Conclusion Pooled phase III data indicate CsA CE produced significant improvement in signs/symptoms versus vehicle in patients with moderate-to-severe DED (especially in those with severe keratitis), including patients with SS with severe DED.

Publication metadata

Author(s): Leonardi A, Messmer EM, Labetoulle M, Amrane M, Garrigue J-S, Ismail D, Sainz-de-la-Maza M, Figueiredo FC, Baudouin C

Publication type: Article

Publication status: Published

Journal: British Journal of Ophthalmology

Year: 2019

Volume: 103

Issue: 1

Pages: 125-131

Print publication date: 01/01/2019

Online publication date: 15/03/2018

Acceptance date: 20/02/2018

Date deposited: 03/01/2019

ISSN (print): 0007-1161

ISSN (electronic): 1468-2079

Publisher: BMJ Publishing Group


DOI: 10.1136/bjophthalmol-2017-311801

PubMed id: 29545413


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