title: Efficacy and safety of a cationic emulsion in the treatment of moderate to severe dry eye disease: a randomized controlled study.
abstract: OBJECTIVE
  To evaluate the efficacy and safety of a preservative-free cationic emulsion (CE) with a 0.18% hyaluronate sodium (HS) solution in patients with moderate to severe dry eye disease (DED) with keratitis or keratoconjunctivitis.
  
  
  METHODS
  Eighty-five patients were randomized (1:1) in this multicenter, prospective, reference-controlled, parallel-group, investigator-masked study to receive CE (n = 44) or HS (n = 41). Clinical signs and symptoms were assessed over 3 months. The primary efficacy endpoint was noninferiority of CE to HS in change from baseline of ocular surface staining (OSS) score at 1 month.
  
  
  RESULTS
  In the per protocol (PP) set and full analysis set (FAS), CE showed a similar and noninferior (p&lt;0.0001) improvement in OSS scores compared with HS at 1 month (PP: -2.5 ± 1.3 vs -1.9 ± 1.6; FAS: -2.2 ± 1.5 vs -2.0 ± 1.8 for CE vs HS). Other clinical signs of DED similarly improved in both groups. In the FAS, global symptoms score of ocular discomfort was significantly better with CE compared with HS at 1 month (-14.8 ± 17.3 vs -7.6 ± 14.2; p = 0.0469), including greater alleviation of itching (-14.8 ± 21.2 vs -1.7 ± 19.7; p = 0.0100) and eye dryness (-21.9 ± 28.3 vs -8.4 ± 21.4; p = 0.0016). Similar trends were observed at 3 months for itching and eye dryness. Investigator global efficacy assessment and quality of life scores for eye pain and driving favored CE at 3 months. Incidence of adverse events was low in both treatment groups.
  
  
  CONCLUSIONS
  CE was similar to HS with regards to safety and efficacy for objective signs but was superior to HS in improving DED symptoms in patients with moderate to severe DED.
authors: Department of Ophthalmology, Dupuytren University Hospital, Limoges - France.
authors: Pierre-Yves
authors: PY
authors: Robert
authors: Brest University Medical School, Department of Ophthalmology, Morvan Hospital, Brest - France.
authors: Béatrice
authors: B
authors: Cochener
authors: Santen SAS, Evry - France.
authors: Mourad
authors: M
authors: Amrane
authors: Santen SAS, Evry - France.
authors: Dahlia
authors: D
authors: Ismail
authors: Santen SAS, Evry - France.
authors: Jean-Sébastien
authors: JS
authors: Garrigue
authors: François Rabelais University, Tours - France.|Department of Ophthalmology, Bretonneau Hospital, Tours - France.
authors: Pierre-Jean
authors: PJ
authors: Pisella
authors: Quinze-Vingts National Ophthalmology Hospital, Paris - France.|UPMC University, Paris 6, Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris - France.|University of Versailles, Saint-Quentin en Yvelines, Versailles - France.
authors: Christophe
authors: C
authors: Baudouin
mesh_terms: D000276:Adjuvants, Immunologic / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004338:Drug Combinations; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000503:physiopathology; D004655:Emulsions; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000627:therapeutic use; D007634:Keratitis / Q000188:drug therapy* / Q000503:physiopathology; D007637:Keratoconjunctivitis / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions; D011142:Polyvinyl Alcohol / Q000009:adverse effects / Q000627:therapeutic use*; D011205:Povidone / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D016037:Single-Blind Method; D013666:Tears / Q000502:physiology; D016896:Treatment Outcome
chemical_list: D000276:Adjuvants, Immunologic; C000598600:Cationorm; D004338:Drug Combinations; D004655:Emulsions; D009883:Ophthalmic Solutions; D011142:Polyvinyl Alcohol; D006820:Hyaluronic Acid; D011205:Povidone