title: A multicenter, double-blind, parallel group, placebo-controlled clinical study to examine the safety and efficacy of T-Clair SPHP700-3 in the management of mild to moderate dry eye in adults.
abstract: OBJECTIVE
  To study the safety and efficacy of T-Clair SPHP700-3, a new over-the-counter preservative-free formulation, in the management of mild to moderate dry eye in adults.
  
  
  METHODS
  Sixty adult patients with mild to moderate dry eye were consecutively recruited in 2 eye clinics and randomized into 2 groups: treatment and placebo. Signs and symptoms of dry eye were compared along 28 days of treatment.
  
  
  RESULTS
  No adverse events were reported during the study. Symptoms and signs of dry eye showed significant differences between the 2 groups after 2 and 4 weeks of treatment.
  
  
  CONCLUSIONS
  SPHP700-3 preservative-free formulation showed to be safe and effective in mild to moderate dry eye, improving tear film stability, ocular surface lubrification, and patients' symptomatology.
authors.affiliation: UO Oculistica, Dipartimento di Neuroscienze e Organi di Senso, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Universitá degli Studi di Milano, Milan, Italy. eddy.villani@tiscali.it
authors.forename: Edoardo
authors.initials: E
authors.lastname: Villani
authors.forename: Guna
authors.initials: G
authors.lastname: Laganovska
authors.forename: Francesco
authors.initials: F
authors.lastname: Viola
authors.forename: Cesare
authors.initials: C
authors.lastname: Pirondini
authors.forename: Kristine
authors.initials: K
authors.lastname: Baumane
authors.forename: Liga
authors.initials: L
authors.lastname: Radecka
authors.forename: Roberto
authors.initials: R
authors.lastname: Ratiglia
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D004338:Drug Combinations; D015352:Dry Eye Syndromes / Q000188:drug therapy* / Q000378:metabolism / Q000503:physiopathology; D015590:Fluorophotometry; D006801:Humans; D008086:Lissamine Green Dyes / Q000378:metabolism; D004366:Nonprescription Drugs; D009883:Ophthalmic Solutions / Q000008:administration & dosage* / Q000009:adverse effects; D010936:Plant Extracts / Q000008:administration & dosage*; D011205:Povidone / Q000008:administration & dosage*; D011310:Preservatives, Pharmaceutical; D011795:Surveys and Questionnaires; D013666:Tears / Q000378:metabolism; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D008086:Lissamine Green Dyes; D004366:Nonprescription Drugs; D009883:Ophthalmic Solutions; D010936:Plant Extracts; D011310:Preservatives, Pharmaceutical; C557983:T-Clair SPHP700-3; D011205:Povidone