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A single intratympanic injection of OTO-313 or placebo was administered to the affected ear and patients were evaluated during a 16-weeks follow-up period. Efficacy was assessed using the Tinnitus Functional Index (TFI), daily ratings of tinnitus loudness and annoyance, and Patient Global Impression of Change (PGIC).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Intratympanic administration of OTO-313 and placebo produced reductions in tinnitus with a similar percentage of TFI responders at Weeks 4, 8, 12, and 16. Reductions in daily ratings of tinnitus loudness and annoyance, and PGIC scores were also similar between OTO-313 and placebo groups. No significant differences in mean TFI scores between OTO-313 and placebo were observed for pre-specified strata regarding tinnitus duration (\u2265\u20092 to\u2009\u2264\u20096\u00a0months and\u2009&gt;\u20096 to\u2009\u2264\u200912\u00a0months) and TFI baseline scores (\u2265\u200932 to\u2009\u2264\u200953 points and\u2009\u2265\u200954 to 100 points), although the results numerically favored OTO-313 in patients in the\u2009\u2265\u20092 to\u2009\u2264\u20096\u00a0months strata. These results also demonstrated an unexpectedly high placebo response particularly amongst patients with chronic tinnitus, despite training implemented to mitigate placebo response. OTO-313 was well-tolerated with a similar incidence of adverse events compared to placebo.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>OTO-313 did not demonstrate a significant treatment benefit relative to placebo due in part to a high placebo response. OTO-313 was safe and well-tolerated.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1007\/s00405-023-08047-0","type":"journal-article","created":{"date-parts":[[2023,6,21]],"date-time":"2023-06-21T11:02:10Z","timestamp":1687345330000},"page":"5307-5318","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["A randomized, double-blind, placebo-controlled phase 2 study of intratympanic OTO-313 in patients with moderate to severe subjective tinnitus"],"prefix":"10.1007","volume":"280","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7303-2159","authenticated-orcid":false,"given":"Grant D.","family":"Searchfield","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James M.","family":"Robinson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Skarinsky","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yiwei","family":"Wang","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffery J.","family":"Anderson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2023,6,21]]},"reference":[{"issue":"10","key":"8047_CR1","doi-asserted-by":"publisher","first-page":"959","DOI":"10.1001\/jamaoto.2016.1700","volume":"142","author":"JM Bhatt","year":"2016","unstructured":"Bhatt JM, Lin HW, Bhattacharyya N (2016) Prevalence, severity, exposures, and treatment patterns of tinnitus in the United States. 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