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Piotr Kuna,1 Marek Jutel,2,3 Grazyna Pulka,4 Slawomir Tokarski,5 Paula Arranz,6 Gonzalo Hernández,6 Nieves Fernández Hernando6 1Department of Internal Medicine, Asthma and Allergy, Medical University of Lodz, Lodz, Poland; 2Department of Clinical Immunology, Wroclaw Medical University, Wrocław, Poland; 3All-Med Medical Research Institute, Wrocław, Poland; 4Centrum Medyczne All-Med, Krakòw, Poland; 5Institute of Medical Sciences, Medical College of Rzeszow University, Rzeszow, Poland; 6Department of Research, Development and Innovation, FAES FARMA, Leioa, Bizkaia, SpainCorrespondence: Nieves Fernández Hernando, FAES FARMA, S.A, Av. Autonomía 10, Leioa, Bizkaia, 48940, Spain, Tel +34 94 481 83 00, Email nfernandez@faes.esPurpose: The objective of this study was to assess the safety and tolerability of preservative-free bilastine 0.6% ophthalmic solution after 8 weeks of once-daily administration in patients with allergic conjunctivitis (AC).Patients and Methods: Multi-center, international, randomized, double blind, placebo-controlled, parallel-group, phase III study of adult patients with seasonal or perennial AC. The study was conducted in 26 centers of 5 European countries. Duration of daily treatment with bilastine 0.6% ophthalmic solution or placebo was 8 weeks. Safety was evaluated by analyzing incidence of ocular treatment-emergent adverse events (TEAEs); additionally, and as secondary parameters, ocular tolerability was assessed, in addition efficacy was also assessed by the average daily total eye symptoms score (TESS).Results: A total of 333 randomized patients with AC were included (bilastine, N=218; placebo, N=115). Mean (SD) age of the patients was 39.9 (13.7) and were 63.7% female. Overall, the percentage of ocular related TEAEs was low, and the percentage of patients with ocular related TEAEs was lower in the bilastine ophthalmic solution group (2.8%) than in the placebo group (4.3%). No severe TEAEs were reported. The ocular symptoms and TESS improved during the trial in both treatment groups. Statistically significant treatment differences were observed at Week 8 for the TESS and all individual ocular symptoms, being significantly better in the bilastine ophthalmic solution group than in placebo group.Conclusion: Bilastine 0.6% ophthalmic solution revealed no safety concerns in patients with AC after 8 weeks of once-daily administration. Bilastine was effective in reducing ocular symptoms associated with AC in response to both seasonal and perennial allergens.Keywords: H1-antihistamine, bilastine, safety, allergic conjunctivitis, ocular allergy, ophthalmic solution