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A randomized study of the efficacy and safety of 0.1% cyclosporine a cationic emulsion in treatment of moderate to severe dry eye

Lookup NU author(s): Professor Francisco FigueiredoORCiD

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Abstract

© 2017 Wichtig Publishing. Purpose: The SICCANOVE study aimed to compare the efficacy and safety of 0.1% cyclosporine A cationic emulsion (CsA CE) versus vehicle in patients with moderate to severe dry eye disease (DED). Methods: In this multicenter, double-masked, parallel-group, controlled study, patients were randomized (1:1) to receive CsA CE (Ikervis®) or vehicle for 6 months. The co-primary efficacy endpoints at month 6 were mean change from baseline in corneal fluorescein staining (CFS; modified Oxford scale) and in global ocular discomfort (visual analogue scale [VAS]). Results: The mean change in CFS from baseline to month 6 (CsA CE: n = 241; vehicle: n = 248) was significantly greater with CsA CE than with vehicle (-1.05 ± 0.98 and -0.82 ± 0.94, respectively; p = 0.009). Ocular discomfort improved similarly in both groups; however, the percentage of patients with ≥25% improvement in VAS was significantly higher with CsA CE (50.2%) than with vehicle (41.9%; p = 0.048). In a post hoc analysis of patients with severe ocular surface damage (CFS score 4) at baseline (CsA CE: n = 43; vehicle: n = 42), the percentage of patients with improvements of ≥2 grades in CFS score and ≥30% in Ocular Surface Disease Index score was significantly greater with CsA CE (p = 0.003). Treatment compliance and ocular tolerability were satisfactory and as expected for CsA use. Conclusion: Cyclosporine A CE was well-tolerated and effectively improved signs and symptoms in patients with moderate to severe DED over 6 months, especially in patients with severe disease, who are at risk of irreversible corneal damage.

Publication metadata

Author(s): Baudouin C, Figueiredo FC, Messmer EM, Ismail D, Amrane M, Garrigue J-S, Bonini S, Leonardi A

Publication type: Article

Publication status: Published

Journal: European Journal of Ophthalmology

Year: 2017

Volume: 27

Issue: 5

Pages: 520-530

Print publication date: 30/08/2017

Online publication date: 21/03/2017

Acceptance date: 20/02/2017

ISSN (print): 1120-6721

Publisher: Wichtig Publishing Srl

URL: https://doi.org/10.5301/EJO.5000952

DOI: 10.5301/EJO.5000952

PubMed id: 28362054

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