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

Acta Ophthalmol. 2011 Nov;89(7):e591-7. doi: 10.1111/j.1755-3768.2011.02196.x. Epub 2011 Aug 11.


Purpose: 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.

Conclusion: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Antioxidants / administration & dosage
  • Biomarkers / metabolism*
  • Conjunctiva / metabolism*
  • Conjunctiva / pathology
  • Dietary Supplements*
  • Double-Blind Method
  • Dry Eye Syndromes / metabolism*
  • Dry Eye Syndromes / physiopathology
  • Fatty Acids, Omega-3 / administration & dosage*
  • Fatty Acids, Omega-6 / administration & dosage*
  • Female
  • Fluorophotometry
  • HLA-DR Antigens / metabolism*
  • Humans
  • Male
  • Middle Aged
  • Quality of Life
  • Surveys and Questionnaires


  • Antioxidants
  • Biomarkers
  • Fatty Acids, Omega-3
  • Fatty Acids, Omega-6
  • HLA-DR Antigens