{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,3]],"date-time":"2026-02-03T18:23:55Z","timestamp":1770143035307,"version":"3.49.0"},"reference-count":49,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2019,10,3]],"date-time":"2019-10-03T00:00:00Z","timestamp":1570060800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Acta Ophthalmologica"],"published-print":{"date-parts":[[2020,5]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Purpose<\/jats:title><jats:p>To assess the safety and efficacy of multi\u2010ingredient sacha inchi microemulsion (<jats:styled-content style=\"fixed-case\">SIME<\/jats:styled-content>) eye drops designed to target (1) tear film instability, (2) tear hyperosmolarity, and (3) ocular surface damage and inflammation in moderate or severe dry eye.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This randomized, quadruple\u2010masked, active\u2010controlled parallel study in 64 adult patients comprised three parts. Part 1 (<jats:italic>n<\/jats:italic>\u00a0=\u00a03): one eye was treated with <jats:styled-content style=\"fixed-case\">SIME<\/jats:styled-content> for one day. Part 2 (<jats:italic>n<\/jats:italic>\u00a0=\u00a09): randomized eyes were treated with <jats:styled-content style=\"fixed-case\">SIME<\/jats:styled-content> and 0.2% hyaluronic acid (<jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content>) control eye drops 3 times a day for 10\u00a0days. Part 3 (<jats:italic>n<\/jats:italic>\u00a0=\u00a026\u00a0+\u00a026): randomized treatment was applied on both eyes 3 times a day for 30\u00a0days. <jats:styled-content style=\"fixed-case\">OSDI<\/jats:styled-content> change was tested for superiority of <jats:styled-content style=\"fixed-case\">SIME<\/jats:styled-content> over <jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content>. Ocular assessments were performed at baseline and after the last dose.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Both treatments were well tolerated without adverse device effects. Tear film break\u2010up time (p\u00a0=\u00a00.0025) and ocular protection index (p\u00a0=\u00a00.0026; change vs. <jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content>, p\u00a0=\u00a00.047) increased significantly with <jats:styled-content style=\"fixed-case\">SIME<\/jats:styled-content> after 30\u00a0days. Tear osmolarity decreased more in <jats:styled-content style=\"fixed-case\">SIME<\/jats:styled-content> than in the <jats:styled-content style=\"fixed-case\">HA<\/jats:styled-content> group and significantly with both eye drops in hyperosmolar subgroups. Corneal (p\u00a0=\u00a00.014) and nasal conjunctival staining (p\u00a0=\u00a00.043) were reduced with <jats:styled-content style=\"fixed-case\">SIME<\/jats:styled-content> in per\u2010protocol patients (<jats:italic>n<\/jats:italic>\u00a0=\u00a024). Conjunctival (p\u00a0=\u00a00.001) and lid redness (p\u00a0=\u00a00.012) decreased with <jats:styled-content style=\"fixed-case\">SIME<\/jats:styled-content> in all patients (<jats:italic>n<\/jats:italic>\u00a0=\u00a026). Symptoms decreased by about 25 <jats:styled-content style=\"fixed-case\">OSDI<\/jats:styled-content> units with both treatments (p\u00a0&lt;\u00a00.0001) and with nonsignificant difference between treatments.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Sacha inchi microemulsion (SIME) proved safe and efficacious in improving each aetiologic factor for dry eye as revealed through objective tests. Hyperosmolar stress dominating blink cycles must be disrupted by biophysical protection of the ocular surface to facilitate resolution of cellular damage and inflammation, and relief of ocular symptoms.<\/jats:p><\/jats:sec>","DOI":"10.1111\/aos.14252","type":"journal-article","created":{"date-parts":[[2019,10,3]],"date-time":"2019-10-03T09:39:36Z","timestamp":1570095576000},"page":"244-254","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":22,"title":["Disease aetiology\u2010based design of multifunctional microemulsion eye drops for moderate or severe dry eye: a randomized, quadruple\u2010masked and active\u2010controlled clinical trial"],"prefix":"10.1111","volume":"98","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5582-0303","authenticated-orcid":false,"given":"Jarmo","family":"Laihia","sequence":"first","affiliation":[{"name":"Finnsusp Ltd Lieto Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Riikka","family":"J\u00e4rvinen","sequence":"additional","affiliation":[{"name":"Finnsusp Ltd Lieto Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edward","family":"Wyl\u0119ga\u0142a","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology District Railway Hospital Katowice Katowice Poland"},{"name":"II School of Medicine with the Division of Dentistry in Zabrze Medical University of Silesia Katowice Poland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kai","family":"Kaarniranta","sequence":"additional","affiliation":[{"name":"Department of Ophthalmology Institute of Clinical Medicine University of Eastern Finland Kuopio Finland"},{"name":"Department of Ophthalmology Kuopio University Hospital Kuopio Finland"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2019,10,3]]},"reference":[{"key":"e_1_2_6_2_1","doi-asserted-by":"publisher","DOI":"10.12688\/f1000research.16468.1"},{"key":"e_1_2_6_3_1","doi-asserted-by":"publisher","DOI":"10.1155\/2016\/8727289"},{"key":"e_1_2_6_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2013.07.003"},{"key":"e_1_2_6_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.002"},{"key":"e_1_2_6_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-200310000-00008"},{"key":"e_1_2_6_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.011"},{"key":"e_1_2_6_8_1","first-page":"1029","article-title":"Trehalose treatment accelerates the healing of UVB\u2010irradiated corneas. 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