{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T02:13:20Z","timestamp":1773281600208,"version":"3.50.1"},"reference-count":15,"publisher":"BMJ","issue":"4","funder":[{"name":"Santen Inc."}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2019,2,11]]},"published-print":{"date-parts":[[2019,4]]},"abstract":"<jats:sec><jats:title>Objectives<\/jats:title><jats:p>Bimatoprost\u2013timolol (bimatoprost 0.03%\u2013timolol 0.5% fixed-dose combination [FDC]) and tafluprost\u2013timolol (tafluprost 0.0015%\u2013timolol 0.5% FDC) eye drops are currently the only topical intraocular pressure (IOP)-reducing therapies available as preservative-free (PF) prostaglandin and timolol FDC. The aim of this study was to investigate changes to ocular signs and symptoms when patients with ocular hypertension (OH) or open-angle glaucoma (OAG) switched from PF or benzalkonium chloride (BAK)-preserved bimatoprost\u2013timolol to PF tafluprost\u2013timolol eye drops.<\/jats:p><\/jats:sec><jats:sec><jats:title>Design<\/jats:title><jats:p>This was a 12-week, open-label, phase IV study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Setting<\/jats:title><jats:p>Sixteen centres in Finland, Germany, Italy and the UK.<\/jats:p><\/jats:sec><jats:sec><jats:title>Participants<\/jats:title><jats:p>Patients with OH or OAG (IOP on medication \u226421\u2009mm Hg), treated with PF or BAK-preserved bimatoprost\u2013timolol for \u22654 weeks before screening, and presenting with conjunctival hyperaemia and \u22651\u2009ocular symptom.<\/jats:p><\/jats:sec><jats:sec><jats:title>Interventions<\/jats:title><jats:p>Patients were switched to PF tafluprost\u2013timolol once daily in the treated eye(s).<\/jats:p><\/jats:sec><jats:sec><jats:title>Primary and secondary outcome measures<\/jats:title><jats:p>The primary endpoints were change from screening to week 12 in conjunctival hyperaemia and worst ocular symptom. The secondary outcome measures were changes from screening in ocular signs (other than conjunctival hyperaemia) and symptoms at week 12.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 123 enrolled patients, 121 were included in the intention-to-treat dataset, of which all were Caucasian and 54.5% were female; 76 patients used BAK-preserved bimatoprost\u2013timolol and 45 used PF drops. Conjunctival hyperaemia and severity of worst ocular symptom following switch to PF tafluprost\u2013timolol significantly reduced from screening to week 12 in all patients (p&lt;0.001). The percentage of patients with ocular signs and symptoms was significantly reduced at week 12 compared with screening (p&lt;0.001). IOP was not affected by the change of treatment.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Switching from BAK-preserved or PF bimatoprost\u2013timolol to tafluprost\u2013timolol reduced both signs and symptoms of ocular surface disease with no clinically relevant effect on IOP.<\/jats:p><\/jats:sec><jats:sec><jats:title>Trial registration number<\/jats:title><jats:p>EudraCT2014-005273-37; Results.<\/jats:p><\/jats:sec>","DOI":"10.1136\/bmjopen-2018-024129","type":"journal-article","created":{"date-parts":[[2019,4,3]],"date-time":"2019-04-03T11:24:32Z","timestamp":1554290672000},"page":"e024129","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":24,"title":["Changes in ocular signs and symptoms in patients switching from bimatoprost\u2013timolol to tafluprost\u2013timolol eye drops: an open-label phase IV study"],"prefix":"10.1136","volume":"9","author":[{"given":"Rupert Richard Alexander","family":"Bourne","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kai","family":"Kaarniranta","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Katrin","family":"Lorenz","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlo Enrico","family":"Traverso","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jouni","family":"Vuorinen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Auli","family":"Ropo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2019,4,2]]},"reference":[{"key":"2024051714214710000_9.4.e024129.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)31469-1"},{"key":"2024051714214710000_9.4.e024129.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2014.05.013"},{"key":"2024051714214710000_9.4.e024129.3","doi-asserted-by":"publisher","DOI":"10.1001\/archopht.118.12.1639"},{"key":"2024051714214710000_9.4.e024129.4","doi-asserted-by":"publisher","DOI":"10.1001\/archopht.120.10.1268"},{"key":"2024051714214710000_9.4.e024129.5","unstructured":"EGS-European Glaucoma Society. 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Savona, Italy: Publicomm, 2014."},{"key":"2024051714214710000_9.4.e024129.6","doi-asserted-by":"crossref","first-page":"932","DOI":"10.1007\/s12325-014-0151-7","article-title":"Fixed-dose combination of tafluprost and timolol in the treatment of open-angle glaucoma and ocular hypertension: comparison with other fixed-combination products","volume":"31","author":"Holl\u00f3","year":"2014","journal-title":"Adv Ther"},{"key":"2024051714214710000_9.4.e024129.7","doi-asserted-by":"crossref","first-page":"129","DOI":"10.1016\/j.ophtha.2015.09.005","article-title":"Comparative effectiveness of first-line medications for primary open-angle glaucoma: a systematic review and network meta-analysis","volume":"123","author":"Li","year":"2016","journal-title":"Ophthalmology"},{"key":"2024051714214710000_9.4.e024129.8","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.86.4.418"},{"key":"2024051714214710000_9.4.e024129.9","doi-asserted-by":"publisher","DOI":"10.1136\/bjophthalmol-2013-304064"},{"key":"2024051714214710000_9.4.e024129.10","doi-asserted-by":"publisher","DOI":"10.1100\/2012\/840421"},{"key":"2024051714214710000_9.4.e024129.11","doi-asserted-by":"crossref","first-page":"329","DOI":"10.1111\/j.1755-3768.2010.01907.x","article-title":"Switching from a preserved to a preservative-free prostaglandin preparation in topical glaucoma medication","volume":"88","author":"Uusitalo","year":"2010","journal-title":"Acta Ophthalmol"},{"key":"2024051714214710000_9.4.e024129.12","doi-asserted-by":"crossref","first-page":"445","DOI":"10.2147\/OPTH.S91402","article-title":"Benefits of switching from latanoprost to preservative-free tafluprost eye drops: a meta-analysis of two Phase IIIb clinical trials","volume":"10","author":"Uusitalo","year":"2016","journal-title":"Clin Ophthalmol"},{"key":"2024051714214710000_9.4.e024129.13","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2007.10.004"},{"key":"2024051714214710000_9.4.e024129.14","doi-asserted-by":"crossref","first-page":"468","DOI":"10.1089\/jop.2013.0229","article-title":"Efficacy, safety, and tolerability of preservative-free fixed combination of tafluprost 0.0015%\/timolol 0.5% versus concomitant use of the ingredients","volume":"30","author":"Holl\u00f3","year":"2014","journal-title":"J Ocul Pharmacol Ther"},{"key":"2024051714214710000_9.4.e024129.15","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1016\/j.ajo.2011.05.033","article-title":"Ocular surface disease and quality of life in patients with glaucoma","volume":"153","author":"Skalicky","year":"2012","journal-title":"Am J Ophthalmol"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2018-024129","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,5,18]],"date-time":"2024-05-18T00:53:22Z","timestamp":1715993602000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2018-024129"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,4]]},"references-count":15,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2019,4,2]]},"published-print":{"date-parts":[[2019,4]]}},"alternative-id":["10.1136\/bmjopen-2018-024129"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2018-024129","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,4]]}}}