title: A multicentre, double-masked, randomized, controlled trial assessing the effect of oral supplementation of omega-3 and omega-6 fatty acids on a conjunctival inflammatory marker in dry eye patients.
abstract: OBJECTIVE
  To determine whether oral supplementation with omega-3 and omega-6 fatty acids can reduce conjunctival epithelium expression of the inflammatory marker human leucocyte antigen-DR (HLA-DR) in patients with dry eye syndrome (DES).
  
  
  METHODS
  This 3-month, double-masked, parallel-group, controlled study was conducted in nine centres, in France and Italy. Eligible adult patients with mild to moderate DES were randomized to receive a placebo containing medium-chain triglycerides or treatment supplement containing omega-3 and omega-6 fatty acids, vitamins and zinc. Treatment regimen was three capsules daily. Impression cytology (IC) was performed at baseline and at month 3 to assess the percentage of cells expressing HLA-DR and to evaluate fluorescence intensity, an alternate measure of HLA-DR. Dry eye symptoms and objective signs were also evaluated. Analyses were performed on the full analysis set (FAS) and per-protocol set (PPS).
  
  
  RESULTS
  In total, 138 patients were randomized; 121 patients with available IC were included in the FAS, and of these, 106 patients had no major protocol deviations (PPS). In the PPS, there was a significant reduction in the percentage of HLA-DR-positive cells in the fatty acids group (p = 0.021). Expression of HLA-DR as measured by fluorescence intensity quantification was also significantly reduced in the fatty acids group [FAS (p = 0.041); PPS (p = 0.017)]. No significant difference was found for the signs and symptoms, but there was a tendency for improvement in patients receiving the fatty acids treatment.
  
  
  CONCLUSIONS
  This study demonstrates that supplementation with omega-3 and omega-6 fatty acids can reduce expression of HLA-DR conjunctival inflammatory marker and may help improve DES symptoms.
authors.affiliation: Department of Toxicology, Paris Descartes University, Paris, France. francoise.brignole@inserm.fr
authors.forename: Françoise
authors.initials: F
authors.lastname: Brignole-Baudouin
authors.forename: Christophe
authors.initials: C
authors.lastname: Baudouin
authors.forename: Pasquale
authors.initials: P
authors.lastname: Aragona
authors.forename: Maurizio
authors.initials: M
authors.lastname: Rolando
authors.forename: Marc
authors.initials: M
authors.lastname: Labetoulle
authors.forename: Pierre Jean
authors.initials: PJ
authors.lastname: Pisella
authors.forename: Stefano
authors.initials: S
authors.lastname: Barabino
authors.forename: Raphaele
authors.initials: R
authors.lastname: Siou-Mermet
authors.forename: Catherine
authors.initials: C
authors.lastname: Creuzot-Garcher
mesh_terms: D000284:Administration, Oral; D000975:Antioxidants / Q000008:administration & dosage; D015415:Biomarkers / Q000378:metabolism*; D003228:Conjunctiva / Q000378:metabolism* / Q000473:pathology; D019587:Dietary Supplements; D004311:Double-Blind Method; D015352:Dry Eye Syndromes / Q000378:metabolism* / Q000503:physiopathology; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage*; D043371:Fatty Acids, Omega-6 / Q000008:administration & dosage*; D005260:Female; D015590:Fluorophotometry; D006684:HLA-DR Antigens / Q000378:metabolism*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D000975:Antioxidants; D015415:Biomarkers; D015525:Fatty Acids, Omega-3; D043371:Fatty Acids, Omega-6; D006684:HLA-DR Antigens