title: Randomized, phase III study comparing osmoprotective carboxymethylcellulose with sodium hyaluronate in dry eye disease.
abstract: OBJECTIVE
  To compare a treatment containing carboxymethylcellulose (CMC) and the osmoprotective (OsPr) compatible osmolytes erythritol, L-carnitine, and glycerin (OsPr-CMC) with a standard sodium hyaluronate (Na-HY) formulation in patients with dry eye disease.
  
  
  METHODS
  This was a 3-month, phase III, noninferiority study. Patients were randomized 1:1 to receive OsPr-CMC (OPTIVE®) or Na-HY (VISMED®). The primary efficacy outcome was the mean change from baseline in total ocular staining at day 35, scored using the 15-point Oxford scale. Noninferiority was assessed using the adjusted means. The secondary efficacy outcome was change in ocular surface disease index (OSDI) score from baseline to day 35. Other outcomes included tear osmolarity, Schirmer-I test score, OSDI, ease of use, patient acceptability, tolerability, and safety.
  
  
  RESULTS
  A total of 82 patients were randomized. The primary efficacy analysis was per protocol (OsPr-CMC, n=37; Na-HY, n=29). OsPr-CMC was noninferior to Na-HY in terms of adjusted mean change (SE) in ocular staining score at day 35: -2.0 (0.33) with OsPr-CMC vs -1.7 (0.37) with Na-HY. Similar improvements were seen in tear osmolarity, Schirmer-I test score, OSDI, and ocular staining for OsPr-CMC and Na-HY. More patients treated with OsPr-CMC vs Na-HY liked using their eyedrops, reported that their eyes felt comfortable, and found the treatment easy to use. Both treatments were well tolerated, with no serious treatment-related adverse events.
  
  
  CONCLUSIONS
  Compared with Na-HY, OsPr-CMC was noninferior in terms of efficacy and safety, preferred by patients, and easier to use. Osmoprotection using OsPr-CMC therefore represents a viable option for dry eye disease management.
authors.affiliation: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts, Paris, France. cbaudouin@quinze-vingts.fr
authors.forename: Christophe
authors.initials: C
authors.lastname: Baudouin
authors.forename: Béatrice
authors.initials: B
authors.lastname: Cochener
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Pisella
authors.forename: Brigitte
authors.initials: B
authors.lastname: Girard
authors.forename: Pascale
authors.initials: P
authors.lastname: Pouliquen
authors.forename: Hazel
authors.initials: H
authors.lastname: Cooper
authors.forename: Catherine
authors.initials: C
authors.lastname: Creuzot-Garcher
mesh_terms: D002266:Carboxymethylcellulose Sodium / Q000008:administration & dosage*; D002331:Carnitine / Q000008:administration & dosage*; D004311:Double-Blind Method; D004338:Drug Combinations; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000503:physiopathology; D004896:Erythritol / Q000008:administration & dosage*; D005260:Female; D005990:Glycerol / Q000008:administration & dosage*; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D013666:Tears / Q000502:physiology; D016896:Treatment Outcome; D055675:Viscosupplements / Q000008:administration & dosage*
chemical_list: D004338:Drug Combinations; D009883:Ophthalmic Solutions; D055675:Viscosupplements; D006820:Hyaluronic Acid; D002266:Carboxymethylcellulose Sodium; D005990:Glycerol; D004896:Erythritol; D002331:Carnitine