title: A randomized, controlled study of the efficacy and safety of a new eyedrop formulation for moderate to severe dry eye syndrome.
abstract: OBJECTIVE
  This study compared the efficacy and safety of hyaluronic acid (HA)-trehalose, a new eyedrop containing trehalose (a natural bioprotectant) and HA, to an established formulation containing only HA.
  
  
  METHODS
  This was a phase III, randomized, active-controlled, investigator-masked, multicenter study in France and Tunisia. In all, 105 adult patients (≥18 years) with moderate to severe dry eye disease (DED) received either HA-trehalose (n = 52) or HA (n = 53) 3-6 times per day for 84 days. The primary efficacy variable was the Oxford grading score at day 35. A questionnaire on dry eye and symptoms, Schirmer test, tear break-up time, conjunctival hyperemia, and global performance were assessed as secondary efficacy criteria at baseline, day 35, and day 84. Safety assessments were standard.
  
  
  RESULTS
  Noninferiority of HA-trehalose to HA for keratoconjunctivitis sicca assessed by Oxford grading score was demonstrated at day 35. For the secondary efficacy parameters, reductions in dry eye questionnaire classes of none or mild at day 84, dry eye symptoms of stinging, itching, and blurred vision at day 35, and investigator (days 35 and 84) and patient assessments (day 35) of global performance were significantly better for HA-trehalose. There were no clinically meaningful differences between groups for the other secondary criteria. Both treatments were well-tolerated, and there were fewer ocular symptoms upon instillation and fewer adverse events for HA-trehalose than for HA.
  
  
  CONCLUSIONS
  Hyaluronic acid-trehalose is effective and safe, with better patient satisfaction, than existing HA-only eyedrops particularly from the first month of treatment, and offers a therapeutic advancement in the treatment of moderate to severe DED.
authors.affiliation: CHU Gabriel-Montpied, Clermont-Ferrand - France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Chiambaretta
authors.affiliation: Bichat Hospital, Paris - France.|Adolphe De Rothschild Ophthalmology Foundation, Paris - France.
authors.forename: Serge
authors.initials: S
authors.lastname: Doan
authors.affiliation: Bicêtre Hospital, Le Kremlin Bicêtre - France.
authors.forename: Marc
authors.initials: M
authors.lastname: Labetoulle
authors.affiliation: Cabinet Médical, Nice - France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Rocher
authors.affiliation: Hôpital des Forces de Sécurité Intérieure, La Marsa - Tunisia.
authors.forename: Lamia El
authors.initials: LE
authors.lastname: Fekih
authors.affiliation: Tahar Sfar University Hospital, Mahdia - Tunisia.
authors.forename: Riadh
authors.initials: R
authors.lastname: Messaoud
authors.affiliation: Department of Ophthalmology, Fattouma Bourguiba Hospital, Monastir - Tunisia.
authors.forename: Moncef
authors.initials: M
authors.lastname: Khairallah
authors.affiliation: Quinze-Vingts National Ophtalmology Hospital DHU Sight Restore, INSERM-DHOS CIC, Paris - France.|Sorbonne University, UPMC Univ Paris 06, INSERM, CNRS, Institut de la Vision, Paris - France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Baudouin
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D004338:Drug Combinations; D015352:Dry Eye Syndromes / Q000175:diagnosis / Q000188:drug therapy*; D005260:Female; D005602:France; D006801:Humans; D006820:Hyaluronic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000009:adverse effects / Q000627:therapeutic use; D017060:Patient Satisfaction; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014199:Trehalose / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D004338:Drug Combinations; D009883:Ophthalmic Solutions; D006820:Hyaluronic Acid; D014199:Trehalose