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Thomas Kaercher,1 Elisabeth M Messmer,2,3 Thomas Berninger,4 Klaudia K Huber-van der Velden,5 Raphaela Geiger,6 Pauline Cipriano-Bonvin,7 Christina Jacobi8,9 1Augenarztpraxis, Heidelberg, Germany; 2Department of Ophthalmology, Ludwig-Maximilian-University, Munich, Germany; 3Praxis Professor Kampik & Kollegen, Munich, Germany; 4Augenzentrum, Olching, Germany; 5Augenheilkunde Lindenthal, Köln-Lindenthal, Germany; 6TRB Chemedica AG, Feldkirchen, Germany; 7TRB Chemedica International SA, Geneva, Switzerland; 8Augen & Haut Zentrum-Praxis Dr. Jacobi, Nuremberg, Germany; 9Friedrich-Alexander University of Erlangen-Nuremberg, Erlangen, GermanyCorrespondence: Thomas Kaercher, Augenarztpraxis, 48 Dossenheimer Landstr, Heidelberg, 69121, Germany, Tel +49 6221 400 888, Fax +49 6221 412 203, Email thomas.kaercher@meibomius.dePurpose: To investigate the efficacy, safety and tolerability of topical omega-3 polyunsaturated fatty acids (PUFA) as an innovative treatment of dry eye disease (DED).Patients and Methods: In a pilot, multicenter, masked-observer, randomized, active-controlled, non-inferiority study in Germany, patients self-treated their eyes with daily instillations of eye drops containing either omega-3 PUFA or povidone as major components for three months. At four and twelve weeks, efficacy was among others evaluated based on Ocular Surface Disease Index (OSDI), ocular surface symptoms intensity, general clinical impression, tear break-up time (TBUT), corneal fluorescein staining using the Oxford grading scale, tear volume, and matrix metalloproteinase-9 (MMP-9) concentration in the tear film. Safety evaluation included visual acuity, intraocular pressure, and the incidence of adverse events. Co-primary endpoints were the mean percent changes from baseline of TBUT and OSDI after four weeks.Results: In total 80 patients were included, of whom 37 in the PUFA group and 39 in the povidone group were evaluable for the co-primary endpoints. Patients had a mean age of 52 years and > 80% were women. Both co-primary endpoints (TBUT and OSDI) significantly improved from baseline in both treatment groups, at Week 4 and Week 12 and the statistical analysis demonstrated topical omega-3 PUFA to be non-inferior to 2% povidone for these two parameters. Both treatments resulted in a significant improvement of most secondary efficacy endpoints as well, often with a slight difference in favor of PUFA, not reaching statistical significance though. One non-severe, treatment-related local AE was reported in each group.Conclusion: Omega-3 PUFA-based eye drops proved to be non-inferior to povidone-containing eye drops in the treatment of signs and symptoms of dry eye. This treatment may thus be an additional tool for the management of DED.Keywords: polyunsaturated fatty acids, povidone, dry eye disease, artificial tears, omega-3 fatty acid