{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,11]],"date-time":"2026-07-11T16:19:14Z","timestamp":1783786754368,"version":"3.55.0"},"reference-count":34,"publisher":"Springer Science and Business Media LLC","issue":"6","license":[{"start":{"date-parts":[[2024,9,11]],"date-time":"2024-09-11T00:00:00Z","timestamp":1726012800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,9,11]],"date-time":"2024-09-11T00:00:00Z","timestamp":1726012800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"Santen Pharmaceutical Co., Ltd.","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Jpn J Ophthalmol"],"published-print":{"date-parts":[[2024,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Purpose<\/jats:title>\n                <jats:p>The high prevalence of allergic conjunctivitis in Japan necessitates novel, easy-to-use treatment options for prophylactic use. We evaluated the safety and efficacy of a newly-developed 0.5% epinastine topical eyelid cream to prevent the development of allergic conjunctivitis.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Study design<\/jats:title>\n                <jats:p>This was a phase 3, single-centre, double-masked, intra-patient randomised trial in asymptomatic adults (aged 20\u201365 years) with seasonal allergic conjunctivitis in Japan.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>The left and right eyes of eligible patients were randomised to receive a topical application of either 0.5% epinastine cream (~\u200930\u00a0mg per dose) to one eye or placebo cream to the other (on the outer skin of the upper and lower eyelids) after a conjunctival antigen challenge (CAC) test. Symptom severity was assessed up to 24\u00a0h post-treatment. Primary efficacy endpoints were mean ocular itching and conjunctival hyperaemia severity scores in each eye; safety endpoints included adverse events (AEs) and adverse drug reaction (ADRs).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>In total, 30 patients (60 eyes) were included in the study. The 0.5% epinastine topical eyelid cream reduced mean ocular itching scores (difference in least squares means\u2009\u00b1\u2009standard error, \u2212\u20091.12\u2009\u00b1\u20090.214; <jats:italic>p\u2009&lt;<\/jats:italic>\u20090.0001) and mean conjunctival hyperaemia scores (\u2212\u20090.54\u2009\u00b1\u20090.197; <jats:italic>p<\/jats:italic>\u2009=\u20090.0097) 24\u00a0h after treatment versus placebo. The 0.5% epinastine topical eyelid cream was well tolerated, with no AEs or ADRs reported.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>With its novel route of administration, 0.5% epinastine topical eyelid cream may be considered a unique, easy-to-use, once-daily treatment option to prevent the onset of seasonal allergic conjunctivitis.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s10384-024-01108-9","type":"journal-article","created":{"date-parts":[[2024,9,11]],"date-time":"2024-09-11T07:02:39Z","timestamp":1726038159000},"page":"651-659","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":15,"title":["Safety and efficacy of a novel 0.5% epinastine topical eyelid cream in allergic conjunctivitis: a phase 3 trial"],"prefix":"10.1007","volume":"68","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5926-5826","authenticated-orcid":false,"given":"Hiroshi","family":"Fujishima","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jun","family":"Shoji","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,9,11]]},"reference":[{"key":"1108_CR1","doi-asserted-by":"publisher","first-page":"459","DOI":"10.1016\/j.alit.2022.07.005","volume":"71","author":"D Miyazaki","year":"2022","unstructured":"Miyazaki D, Fukushima A, Uchio E, Shoji J, Namba K, Ebihara N, et al. Executive summary: Japanese guidelines for allergic conjunctival diseases 2021. Allergol Int. 2022;71:459\u201371.","journal-title":"Allergol Int"},{"key":"1108_CR2","first-page":"741","volume":"125","author":"Japanese society of ophthalmic alle","year":"2021","unstructured":"Japanese society of ophthalmic allergy clinical practice guideline development committee. Clinical practice guidelines for allergic conjunctival diseases (3rd edition). Nippon Ganka Gakkai Zasshi. 2021;125:741\u201385. (in Japanese).","journal-title":"Nippon Ganka Gakkai Zasshi"},{"key":"1108_CR3","doi-asserted-by":"publisher","first-page":"5","DOI":"10.1186\/s13223-020-0403-9","volume":"16","author":"P Dupuis","year":"2020","unstructured":"Dupuis P, Prokopich CL, Hynes A, Kim H. A contemporary look at allergic conjunctivitis. 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Fujishima, Grants to the author\u2019s institution (Santen), Research grant (White Medical, Kobayashi), Consulting fees (Santen), Lecture fees (Santen, Senju, Otsuka), Payment for expert testimony (Santen, Kobayashi); J. Shoji, Grants to the author\u2019s institution (Santen), Consulting fees (Santen); Lecture fees (Santen, Senju, AbbVie, Rohto Nitten).","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}