{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,18]],"date-time":"2026-09-18T02:14:09Z","timestamp":1789697649526,"version":"4.0.1"},"reference-count":17,"publisher":"Springer Science and Business Media LLC","issue":"7","license":[{"start":{"date-parts":[[2020,4,13]],"date-time":"2020-04-13T00:00:00Z","timestamp":1586736000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2020,4,13]],"date-time":"2020-04-13T00:00:00Z","timestamp":1586736000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"NTC srl, Milan \u2013 Italy","award":["EUDRA CT code: 2018-001149-15."],"award-info":[{"award-number":["EUDRA CT code: 2018-001149-15."]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Eur J Clin Pharmacol"],"published-print":{"date-parts":[[2020,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n<jats:title>Purpose<\/jats:title>\n<jats:p>To evaluate the penetration of levofloxacin and dexamethasone sodium phosphate into the aqueous humour (AH) after administration in combination and as single molecules. Evaluation of the penetration of those agents in the site of action and their pharmacodynamic potential activity in view of the intended clinical use after cataract surgery.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Methods<\/jats:title>\n<jats:p>Randomised, assessor-blinded, parallel-group. Patients scheduled for cataract surgery were assigned in a 1:1:1 ratio to: levofloxacin + dexamethasone sodium phosphate (L-DSP), Levofloxacin (L) or Dexamethasone sodium phosphate (DSP) eye drops. Either test or reference drugs were instilled in the cul-de-sac twice, 90 and 60\u00a0min before paracentesis.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Results<\/jats:title>\n<jats:p>A total of 125 patients completed the study. Fraction of dose absorbed in the anterior chamber was 3.8\u20134.2 \u00b7 10<jats:sup>\u22124<\/jats:sup> for levofloxacin and 0.3\u20130.4 \u00b7 10<jats:sup>\u22124<\/jats:sup> for dexamethasone, respectively. No notable differences in concentration of levofloxacin were found between L-DSP arm (1.970\u00a0nmol\/ml) and L arm (2.151\u00a0nmol\/ml). The concentrations of levofloxacin were well above the MICs for the most frequent Gram-positive and Gram-negative eye pathogens. Dexamethasone concentrations were slightly lower in L-DSP arm (0.030\u00a0nmol\/ml) than in DSP arm (0.042\u00a0nmol\/ml), but still in the pharmacodynamically active range in the site of action. The difference was not clinically relevant. DSP was not detected in any HA sample, suggesting its full hydrolysis to free dexamethasone.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Conclusion<\/jats:title>\n<jats:p>Our results confirm that no interaction is evident on the corneal penetration of levofloxacin and dexamethasone which reach pharmacologically active concentrations when instilled as fixed combination eye drops to patients undergoing cataract surgery.<\/jats:p>\n<\/jats:sec><jats:sec>\n<jats:title>Trial registration<\/jats:title>\n<jats:p>ClinicalTrials.gov Identifier: <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03740659?term=NTC+srl&amp;cond=cataract&amp;draw=2&amp;rank=1\">NCT03740659<\/jats:ext-link><\/jats:p>\n<\/jats:sec>","DOI":"10.1007\/s00228-020-02863-7","type":"journal-article","created":{"date-parts":[[2020,4,13]],"date-time":"2020-04-13T05:02:43Z","timestamp":1586754163000},"page":"929-937","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":9,"title":["Aqueous humour concentrations after topical apPlication of combinEd levofloxacin-dexamethasone eye dRops and of its single components: a randoMised, assEssor-blinded, parallel-group study in patients undergoing cataract surgery: the iPERME study"],"prefix":"10.1007","volume":"76","author":[{"given":"Michele","family":"Figus","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chiara","family":"Posarelli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dario","family":"Romano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Nardi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luca","family":"Rossetti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2020,4,13]]},"reference":[{"key":"2863_CR1","unstructured":"Barry P, Cordov\u00e9s L, Gardner S ESCRS Guidelines for prevention and treatment of endophthalmitis following cataract surgery: data, dilemmas and conclusions 2013. https:\/\/www.escrs.org\/downloads\/Endophthalmitis-Guidelines.pdf. last accessed 7 Sept 2019"},{"key":"2863_CR2","doi-asserted-by":"publisher","first-page":"1421","DOI":"10.1016\/j.jcrs.2013.06.014","volume":"39","author":"A Behndig","year":"2013","unstructured":"Behndig A, Cochener B, Guell JL et al (2013) Endophthalmitis prophylaxis in cataract surgery: overview of current practice patterns in 9 European countries. 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