title: [Efficacy assessment of Nutrilarm®, a per os omega-3 and omega-6 polyunsaturated essential fatty acid dietary formulation versus placebo in patients with bilateral treated moderate dry eye syndrome].
abstract: BACKGROUND
  Inflammation is one of the main mechanisms common to all forms of dry eye. Since polyunsaturated acids are known to show biological anti-inflammatory properties, the aim of this study was to evaluate the efficacy of dietary n-6 and n-3 fatty acids in patients suffering from ocular dryness.
  
  
  METHODS
  One hundred and eighty-one patients diagnosed with bilateral moderate dry eye who were already treated with lachrymal substitutes were randomized in a double-blind international study to receive placebo or Nutrilarm(®) capsules (combination of omega-3 and omega-6), twice a day for 6 months. In all subjects, dryness feeling, overall subjective comfort, and ocular symptoms (burning, stinging, sandy and/or gritty sensation, light sensitivity, reflex tearing, and ocular fatigue) were evaluated at each visit. Furthermore, fluorescein tests (break-uptime and Oxford scheme) and lissamine green test were performed at each visit. The Schirmer test was performed at inclusion and after 6 months of treatment.
  
  
  RESULTS
  After 6 months of supplementation with Nutrilarm(®), both the BUT scores and ocular fatigue were significantly improved when compared with placebo (P=0.036 and P=0.044, respectively). There was a trend in favor of Nutrilarm(®) in terms of the efficacy evaluated by the investigator (P=0.061). Fewer patients experienced a feeling of severe dryness with Nutrilarm(®) compared with placebo after 6 months of treatment (2.5 and 9.3%, respectively), but the difference was not statistically significant.
  
  
  CONCLUSIONS
  Oral administration of a double supplementation dietary n-6 and n-3 fatty acids present an additional therapeutic advantage in patients suffering from ocular dryness who were already treated with lachrymal substitutes.
authors.affiliation: CHU de Dijon, 3, rue du Faubourg-Raines, 21033 Dijon cedex, France. catherine.creuzot-garcher@chu-dijon.fr
authors.forename: C
authors.initials: C
authors.lastname: Creuzot-Garcher
authors.forename: C
authors.initials: C
authors.lastname: Baudouin
authors.forename: M
authors.initials: M
authors.lastname: Labetoulle
authors.forename: P-J
authors.initials: PJ
authors.lastname: Pisella
authors.forename: F
authors.initials: F
authors.lastname: Mouriaux
authors.forename: A
authors.initials: A
authors.lastname: Meddeb-Ouertani
authors.forename: L
authors.initials: L
authors.lastname: El Matri
authors.forename: M
authors.initials: M
authors.lastname: Khairallah
authors.forename: F
authors.initials: F
authors.lastname: Brignole-Baudouin
mesh_terms: D000284:Administration, Oral; D015352:Dry Eye Syndromes / Q000178:diet therapy*; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D043371:Fatty Acids, Omega-6 / Q000008:administration & dosage*; D005260:Female; D005526:Food, Formulated; D006801:Humans; D008297:Male; D008875:Middle Aged; D012720:Severity of Illness Index
chemical_list: D015525:Fatty Acids, Omega-3; D043371:Fatty Acids, Omega-6; C569460:Nutrilarm