title: Ocular tolerability and efficacy of a cationic emulsion in patients with mild to moderate dry eye disease - a randomised comparative study.
abstract: OBJECTIVE
  The purpose of this study was to compare the safety and efficacy of a new cationic emulsion (CE) with a formulation of polyvinyl alcohol and povidone (PVA-P) for the treatment of mild to moderate dry eye disease.
  
  
  METHODS
  This was a multicenter, open-label, comparative study. Patients were randomised to receive CE (Cationorm) or PVA-P (Refresh) (1:1). The following objective criteria were assessed to compare the two eye drops: tear Break-up Time (TBUT), Schirmer's test, lissamine green staining (Van Bijsterveld score), corneal fluorescein staining (Oxford scale) and oculopalpebral examination, on D7 and D28 (end of study). At these visits, ocular symptoms and safety were also assessed.
  
  
  RESULTS
  Seventy-nine patients were randomised: CE: 44 patients; PVA-P: 35 patients. At D28, improvement was significantly better for TBUT [CE: 1.7 ± 2.4 s; PVA-P: 0.6 ± 1.8 s; P=0.015] and for the Van Bijsterveld score [CE: -1.4 ± 1.2; PVA-P: -0.9 ± 1.2; P=0.046] in the CE group. The same applied for the palpebral erythema score (P=0.023), overall efficacy assessed by the investigators (P<0.001), and symptoms not related to eye drop instillation (P=0.021). Improvement was observed from D7. No difference was observed between the two treatments with regard to ocular safety.
  
  
  CONCLUSIONS
  These results suggest that in patients with mild to moderate dry eye, Cationorm, in addition to its moisturizing and lubricating properties, also helps stabilize the tear film due to its oily component. This study demonstrates the benefit of this new pharmaceutical form for the treatment of mild to moderate dry eye disease.
authors.affiliation: Santen SAS, 1, rue Pierre-Fontaine, 91058 Evry cedex, France. Electronic address: mourad.amrane@santen.fr.
authors.forename: M
authors.initials: M
authors.lastname: Amrane
authors.affiliation: Service d'ophtalmologie, CHU de Dijon, 3, rue du Faubourg-Raines, 21000 Dijon, France.
authors.forename: C
authors.initials: C
authors.lastname: Creuzot-Garcher
authors.affiliation: Service d'ophtalmologie, CHU Dupuytren, 2, avenue Martin-Luther-King, 87000 Limoges, France.
authors.forename: P-Y
authors.initials: PY
authors.lastname: Robert
authors.affiliation: Santen SAS, 1, rue Pierre-Fontaine, 91058 Evry cedex, France.
authors.forename: D
authors.initials: D
authors.lastname: Ismail
authors.affiliation: Santen SAS, 1, rue Pierre-Fontaine, 91058 Evry cedex, France.
authors.forename: J-S
authors.initials: JS
authors.lastname: Garrigue
authors.affiliation: Service d'ophtalmologie, CHU Bretonneau, 2, boulevard Tonnellé, 37000 Tours, France.
authors.forename: P-J
authors.initials: PJ
authors.lastname: Pisella
authors.affiliation: Service d'ophtalmologie, Centre national d'ophtalmologie des Quinze-Vingts, institut de la vision, université Paris 6, 28, rue de Charenton, 75012 Paris, France; Hôpital Ambroise-Paré, AP-HP, 9, avenue Charles-de-Gaulle, 92100 Boulogne-Billancourt, France; Université de Versailles Saint-Quentin-en-Yvelines, 55, avenue de Paris, 78000 Versailles, France.
authors.forename: C
authors.initials: C
authors.lastname: Baudouin
mesh_terms: D060433:Administration, Ophthalmic; D000368:Aged; D004338:Drug Combinations; D015352:Dry Eye Syndromes / Q000188:drug therapy*; D004655:Emulsions / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D005260:Female; D019793:Fluorescein; D006801:Humans; D008086:Lissamine Green Dyes; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use*; D011142:Polyvinyl Alcohol / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D011205:Povidone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology / Q000627:therapeutic use; D012720:Severity of Illness Index; D013666:Tears / Q000187:drug effects; D016896:Treatment Outcome
chemical_list: C000598600:Cationorm; D004338:Drug Combinations; D004655:Emulsions; D008086:Lissamine Green Dyes; D009883:Ophthalmic Solutions; D011142:Polyvinyl Alcohol; D011205:Povidone; D019793:Fluorescein
keywords: Cationic emulsion; Dry eye; Film lacrymal; Tear film; Émulsion cationique; Œil sec