{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T18:00:50Z","timestamp":1790618450721,"version":"4.1.0"},"reference-count":39,"publisher":"Public Library of Science (PLoS)","issue":"9","license":[{"start":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T00:00:00Z","timestamp":1790553600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"SCAI Therapeutics","award":["SCAI-001-201"],"award-info":[{"award-number":["SCAI-001-201"]}]}],"content-domain":{"domain":["www.plosone.org"],"crossmark-restriction":false},"short-container-title":["PLoS One"],"abstract":"<jats:sec id=\"sec001\">\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>\n                      This study aimed to evaluate the efficacy and safety of low-concentration, nanoparticle-based cyclosporine eye drops (SCAI-001 0.01% and SCAI-001 0.02%) compared to those of the conventional Restasis\n                      <jats:sup>\u00ae<\/jats:sup>\n                      (cyclosporine 0.05%) emulsion for dry eye disease (DED).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec002\">\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this multicenter, randomized, double-blind, Phase 2 trial, patients with DED were assigned to three groups: SCAI-001 0.01%, SCAI-001 0.02%, and Restasis. The primary efficacy endpoint was the change in tear volume after 12 weeks. Secondary efficacy endpoints included changes in tear volume at 4 and 8 weeks, corneal and conjunctival surface staining scores, tear film breakup time (TBUT), standard patient evaluation of eye dryness questionnaire score (SPEED), and ocular surface disease index (OSDI) at 4, 8, and 12 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec003\">\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Tear volume increased in all groups at 12 weeks without intergroup differences. SCAI-001 0.01% and SCAI-001 0.02% achieved earlier improvements in tear volume at 4 weeks than that of Restasis, although no significant between-group difference was observed at any time point. Conjunctival surface scores improved in all groups at 4, 8, and 12 weeks, excluding 4 weeks of Restasis. Conjunctival staining improved to a greater extent with SCAI-001 0.01% than with Restasis at weeks 4 and 8. Corneal surface scores, TBUT, SPEED, and OSDI scores improved in all groups at 4, 8, and 12 weeks without intergroup differences.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec004\">\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Low-concentration cyclosporine (SCAI-001 0.01% and SCAI-001 0.02%) demonstrated efficacy and safety comparable to that of Restasis in improving DED measures.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec id=\"sec005\">\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Identifier:\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05733624\" xlink:type=\"simple\">NCT05733624<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1371\/journal.pone.0358007","type":"journal-article","created":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T17:26:11Z","timestamp":1790616371000},"page":"e0358007","update-policy":"https:\/\/doi.org\/10.1371\/journal.pone.corrections_policy","source":"Crossref","is-referenced-by-count":0,"title":["Comparative study on the clinical effectiveness of low-concentration cyclosporine eye drops in patients with dry eye disease"],"prefix":"10.1371","volume":"21","author":[{"given":"Jae Hyun","family":"Kim","sequence":"first","affiliation":[{"name":"Pusan National University School of Medicine","place":["Busan, South Korea"],"department":["Department of Ophthalmology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hui Kyung","family":"Kim","sequence":"additional","affiliation":[{"name":"Pusan National University School of Medicine","place":["Busan, South Korea"],"department":["Department of Ophthalmology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Young-Joo","family":"Shin","sequence":"additional","affiliation":[{"name":"Hallym University Kangnam Sacred Heart Hospital","place":["Seoul, South Korea"],"department":["Department of Ophthalmology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chul Young","family":"Choi","sequence":"additional","affiliation":[{"name":"Kangbuk Samsung Hospital","place":["Seoul, South Korea"],"department":["Department of Ophthalmology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9283-3506","authenticated-orcid":true,"given":"Hong Kyun","family":"Kim","sequence":"additional","affiliation":[{"name":"Kyungpook National University Hospital","place":["Daegu, South Korea"],"department":["Department of Ophthalmology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eunchul","family":"Kim","sequence":"additional","affiliation":[{"name":"The Catholic University of Korea, Bucheon ST. Mary\u2019s Hospital","place":["Bucheon, South Korea"],"department":["Department of Ophthalmology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jae Yong","family":"Kim","sequence":"additional","affiliation":[{"name":"Asan Medical Center","place":["Seoul, South Korea"],"department":["Department of Ophthalmology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4927-2854","authenticated-orcid":true,"given":"Ji Eun","family":"Lee","sequence":"additional","affiliation":[{"name":"Pusan National University Yangsan Hospital","place":["Yangsan, South Korea"],"department":["Department of Ophthalmology"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"SunWoong","family":"Kim","sequence":"additional","affiliation":[{"name":"Yonsei University Wonju Severance Christian Hospital","place":["Wonju, South Korea"],"department":["Department of 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