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Baudouin, Christophe; Figueiredo, Francisco C.; Messmer, Elisabeth M.; Ismail, Dahlia; Amrane, Mourad; Garrigue, Jean-Sebastien; Bonini, Stefano; Leonardi, Andrea (2017): A randomized study of the efficacy and safety of 0.1% cyclosporine A cationic emulsion in treatment of moderate to severe dry eye. In: European Journal of Ophthalmology, Vol. 27, No. 5: pp. 520-530
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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 (R)) 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.