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

Eur J Ophthalmol 2017; 27(5): 520 - 530

Article Type: ORIGINAL RESEARCH ARTICLE

DOI:10.5301/EJO.5000952

Authors

Baudouin, Christophe Figueiredo, Francisco C. Messmer, Elisabeth M. Ismail, Dahlia Amrane, Mourad Garrigue, Jean-Sébastien Bonini, Stefano Leonardi, Andrea

Abstract

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.

Article History

Disclosures

Financial support: The SICCANOVE study was sponsored by Santen SAS, Evry, France.
Conflict of interest: C. Baudouin is a consultant for, or has received research grants from, Alcon, Allergan, Santen, and Théa and was an international coordinator in the SICCANOVE study. F. Figueiredo is a consultant for Santen and Théa. E. Messmer is a consultant for and has received research grants from Allergan, Dompé, and Santen and has also received research grants from Alcon, Croma Pharma, Farmigea, Oculus Optikgeräte, Théa, and Ursapharm. M. Amrane, J.S. Garrigue, and D. Ismail are employees of Santen SAS. S. Bonini is a consultant for Alcon, Allergan, Dompè, Santen, Sifi, and Sooft. A. Leonardi is a consultant for Alcon, Allergan, Santen, Sifi, and Théa. F. Figueiredo, E. Messmer, S. Bonini, and A. Leonardi were investigators in the SICCANOVE study.

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