{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,15]],"date-time":"2026-07-15T23:53:25Z","timestamp":1784159605997,"version":"3.55.0"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2024,7,29]],"date-time":"2024-07-29T00:00:00Z","timestamp":1722211200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2024,7,29]],"date-time":"2024-07-29T00:00:00Z","timestamp":1722211200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Ophthalmol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Primary open-angle glaucoma (POAG), often associated with increased intraocular pressure (IOP), can lead to permanent damage of the optic nerve, concomitant visual field loss, and blindness. Latanoprost, a prostaglandin F2\u03b1 analogue, reduces IOP and is used to treat glaucoma. In this clinical trial, we evaluated the efficacy of Latanoprost Polpharma, a generic preservative-free latanoprost 0.05\u00a0mg\/ml eye drops solution, in lowering IOP when compared to the originator Xalatan<jats:sup>\u00ae<\/jats:sup> (latanoprost 0.005% ophthalmic solution, Pfizer).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This was a Phase III, multicentre, randomized, investigator-masked, cross-over, comparative, non-inferiority trial carried out in 5 sites in Hungary and Russia. The primary endpoint was to evaluate the non-inferiority of the test product when compared to the reference product with respect to the differences in the mean diurnal IOP on Day 1 (baseline) and Day 29. The secondary endpoints included efficacy, ocular tolerance, safety, and usability. We recruited adult patients (18\u201375 years) with open-angle glaucoma or ocular hypertension.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Forty-nine patients were randomised and received at least one dose of the test or reference product. A virtually identical reduction of the mean diurnal IOP of 7.04\u2009\u00b1\u20092.14 mmHg or 7.17\u2009\u00b1\u20092.11 mmHg was found after treatment with test or reference product, respectively (<jats:italic>N<\/jats:italic>\u2009=\u200944). In the intention to treat analysis, the reduction was 7.29\u2009\u00b1\u20092.53 mmHg (95% CI: 6.55\u20138.04) or 7.43\u2009\u00b1\u20092.78\u00a0mm Hg (95%CI: 6.61\u20138.24) after treatment with test or reference product, respectively (<jats:italic>N<\/jats:italic>\u2009=\u200947). There were no serious adverse events.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Latanoprost Polpharma was shown to be non-inferior to Xalatan<jats:sup>\u00ae<\/jats:sup>. Both investigational products were equally well tolerated and safe. The data show a trend in favour of the test product with regards to the severity of hyperaemia and to the velocity of remission of ocular discomfort. Latanoprost Polpharma, being preservative-free, also avoids the cytotoxicity of benzalkonium chloride, the side effects of which may affect patient compliance and lower the quality of life.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>The study had the ethical and regulatory approval from the National Institute of Pharmacy and Nutrition (OGYEI, OGYEI\/41,779- 11\/2018) and the Ethics Committee for Clinical Pharmacology (KFEB) of Hungary and from the Ministry of Healthcare of the Russian Federation (MOH of Russia) prior to the beginning of the study (642\/25.12.2018) (clinical trial identification number: 848,300,144\/0103\/1 - POP03; IND number\/EudraCT number: 2018-001727-39).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12886-024-03579-3","type":"journal-article","created":{"date-parts":[[2024,7,29]],"date-time":"2024-07-29T09:05:07Z","timestamp":1722243907000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A phase III, multicentre, randomised, investigator-masked, cross-over, comparative, non-inferiority trial evaluating the efficacy and tolerability of generic preservative-free Latanoprost (Polpharma S.A.) compared to Xalatan\u00ae (Pfizer) in patients with ocular hypertension or primary open-angle glaucoma"],"prefix":"10.1186","volume":"24","author":[{"given":"Norbert","family":"Czumbel","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tamas","family":"Acs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gyorgy","family":"Bator","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Agnes","family":"Halmosi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evgeniy A.","family":"Egorov","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitrii S.","family":"Maltsev","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,7,29]]},"reference":[{"key":"3579_CR1","doi-asserted-by":"crossref","unstructured":"Crick RP, Khaw PT. A Textbook of Clinical Ophthalmology. 3rd edition. World Scientific Publishing; 2003.","DOI":"10.1142\/5074"},{"key":"3579_CR2","doi-asserted-by":"publisher","first-page":"138","DOI":"10.1016\/S0161-6420(96)30749-5","volume":"103","author":"CB Camras","year":"1996","unstructured":"Camras CB. Comparison of Latanoprost and Timolol in patients with ocular hypertension and Glaucoma. Ophthalmology. 1996;103:138\u201347.","journal-title":"Ophthalmology"},{"key":"3579_CR3","doi-asserted-by":"publisher","first-page":"126","DOI":"10.1016\/S0161-6420(96)30750-1","volume":"103","author":"P Watson","year":"1996","unstructured":"Watson P, Stjernschantz JA, Six-month. Randomized, double-masked study comparing latanoprost with Timolol in Open-angle Glaucoma and ocular hypertension. Ophthalmology. 1996;103:126\u201337.","journal-title":"Ophthalmology"},{"key":"3579_CR4","unstructured":"FDA. 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Benzalkonium chloride induces anterior chamber inflammation in previously untreated patients with ocular hypertension as measured by flare meter: a randomized clinical trial. Acta Ophthalmol. 2012;90:e221\u20134.","journal-title":"Acta Ophthalmol"},{"key":"3579_CR8","doi-asserted-by":"publisher","first-page":"88","DOI":"10.1016\/j.jtos.2022.07.012","volume":"26","author":"E Ivakhnitskaia","year":"2022","unstructured":"Ivakhnitskaia E, Souboch V, Dallacasagrande V, Mizerska K, Souboch E, Sarkar J, et al. Benzalkonium chloride, a common ophthalmic preservative, compromises rat corneal cold sensitive nerve activity. Ocul Surf. 2022;26:88\u201396.","journal-title":"Ocul Surf"},{"key":"3579_CR9","doi-asserted-by":"publisher","first-page":"e50180","DOI":"10.1371\/journal.pone.0050180","volume":"7","author":"F Brignole-Baudouin","year":"2012","unstructured":"Brignole-Baudouin F, Desbenoit N, Hamm G, Liang H, Both J-P, Brunelle A, et al. A New Safety concern for Glaucoma treatment demonstrated by Mass Spectrometry Imaging of Benzalkonium Chloride distribution in the Eye, an experimental study in rabbits. PLoS ONE. 2012;7:e50180.","journal-title":"PLoS ONE"},{"key":"3579_CR10","doi-asserted-by":"publisher","first-page":"312","DOI":"10.1016\/j.preteyeres.2010.03.001","volume":"29","author":"C Baudouin","year":"2010","unstructured":"Baudouin C, Labb\u00e9 A, Liang H, Pauly A, Brignole-Baudouin F. Preservatives in eyedrops: the good, the bad and the ugly. Prog Retin Eye Res. 2010;29:312\u201334.","journal-title":"Prog Retin Eye Res"},{"key":"3579_CR11","doi-asserted-by":"publisher","first-page":"1941","DOI":"10.1007\/s00417-021-05536-y","volume":"260","author":"J Tau","year":"2022","unstructured":"Tau J, Passerini MS, del Papa M, Aguilar A, Berra A. A novel ophthalmic latanoprost 0.005% nanoemulsion: a cytotoxicity study. 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Cornea. 2016;35:234\u201342.","journal-title":"Cornea"}],"container-title":["BMC Ophthalmology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12886-024-03579-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12886-024-03579-3\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12886-024-03579-3.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,7,29]],"date-time":"2024-07-29T09:08:13Z","timestamp":1722244093000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmcophthalmol.biomedcentral.com\/articles\/10.1186\/s12886-024-03579-3"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,7,29]]},"references-count":17,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2024,12]]}},"alternative-id":["3579"],"URL":"https:\/\/doi.org\/10.1186\/s12886-024-03579-3","relation":{},"ISSN":["1471-2415"],"issn-type":[{"value":"1471-2415","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,7,29]]},"assertion":[{"value":"19 December 2023","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"17 July 2024","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"29 July 2024","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The study had the ethical and regulatory approval from the National Institute of Pharmacy and Nutrition (OGYEI, OGYEI\/41779- 11\/2018) and the Ethics Committee for Clinical Pharmacology (KFEB) of Hungary and from the Ministry of Healthcare of the Russian Federation (MOH of Russia) prior to the beginning of the study (642\/25.12.2018). The study was conducted in accordance with the ICH guidelines for Good Clinical Practice (GCP, E6) and the Declaration of Helsinki (Version 6 of 64th General Assembly of WMA in Fortaleza, Brazil 2013). Data management was conducted in compliance with Good Clinical Data Management Practices.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Informed consent was obtained from all the patients included in the study prior to any study-related activities and in accordance with all applicable regulatory requirements. The investigator and\/or his\/her designee orally informed every patient in addition to the written patient information about all aspects of the patient\u2019s participation in the study.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"The authors declare that they have no competing interests.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"313"}}