title: A randomized study of the efficacy and safety of 0.1% cyclosporine A cationic emulsion in treatment of moderate to severe dry eye.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Quinze-Vingts National Ophthalmology Hospital, Paris - France.|Pierre et Marie Curie University, Paris 6, Vision Institute, INSERM UMR968, CNRS UMR7210, Paris - France.|University of Versailles Saint-Quentin en Yvelines, Versailles - France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Baudouin
authors.affiliation: Royal Victoria Infirmary, Newcastle University, Newcastle upon Tyne - UK.
authors.forename: Francisco C
authors.initials: FC
authors.lastname: Figueiredo
authors.affiliation: Department of Ophthalmology, Ludwig-Maximilians-University, Munich - Germany.
authors.forename: Elisabeth M
authors.initials: EM
authors.lastname: Messmer
authors.affiliation: Santen SAS, Evry - France.
authors.forename: Dahlia
authors.initials: D
authors.lastname: Ismail
authors.affiliation: Santen SAS, Evry - France.
authors.forename: Mourad
authors.initials: M
authors.lastname: Amrane
authors.affiliation: Santen SAS, Evry - France.
authors.forename: Jean-Sébastien
authors.initials: JS
authors.lastname: Garrigue
authors.affiliation: Campus Bio Medico, Università di Roma, Rome - Italy.
authors.forename: Stefano
authors.initials: S
authors.lastname: Bonini
authors.affiliation: Department of Neuroscience, Ophthalmology Unit, University of Padua, Padua - Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Leonardi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016572:Cyclosporine / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000175:diagnosis / Q000188:drug therapy*; D004655:Emulsions; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D004655:Emulsions; D007166:Immunosuppressive Agents; D009883:Ophthalmic Solutions; D016572:Cyclosporine