A Randomized Study of the Efficacy and Safety of 0.1% Cyclosporine a Cationic Emulsion in Treatment of Moderate to Severe Dry Eye. Issue 5 (September 2017)

• Record Type: Journal Article
• Authors: Baudouin, Christophe; Figueiredo, Francisco C.; Messmer, Elisabeth M.; Ismail, Dahlia; Amrane, Mourad; Garrigue, Jean-Sébastien; Bonini, Stefano; Leonardi, Andrea
• Is Part Of: European journal of ophthalmology. Volume 27:Issue 5(2017)
• Page Start: 520
• Page End: 530
• Publication Date: 2017-09
• Subjects: Cationic emulsion -- CsA -- Cyclosporine -- Dry eye disease -- Severe keratitis; Ophthalmology -- Periodicals; Eye -- Diseases -- Periodicals; 617.7005
• DOI: 10.5301/ejo.5000952
• Languages: English
• ISSNs: 1120-6721

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.