{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T06:11:02Z","timestamp":1792390262383,"version":"4.4.0"},"reference-count":17,"publisher":"SAGE Publications","issue":"5","license":[{"start":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T00:00:00Z","timestamp":1654041600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2022,6,1]],"date-time":"2022-06-01T00:00:00Z","timestamp":1654041600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Ocular Pharmacology and Therapeutics"],"published-print":{"date-parts":[[2022,6,1]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose:<\/jats:title>\n                    <jats:p>\n                      NovaTears\n                      <jats:sup>\u00ae<\/jats:sup>\n                      +Omega-3 is a water-free eye drop solution with non-animal-derived omega-3 fatty acids. It allows to supplement omega-3 fatty acids directly in the tear film of patients with dry eye disease (DED). This post-market clinical follow-up (PMCF) study evaluated for the first time the effects on clinical signs and patient symptoms of DED, and safety and tolerability of NovaTears+Omega-3 (0.2%) eye drops, when used in accordance with its approved label.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods:<\/jats:title>\n                    <jats:p>A prospective, multicenter, single-arm, uncontrolled, open-label observational cohort study was performed in patients suffering from symptoms of evaporative DED. Patients were treated 4 times daily bilaterally according to the instructions for use for 8 weeks, and standard of care clinical end points were assessed at baseline and follow-up. The trial was conducted at 2 investigational sites in Germany, Europe.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Thirty-six patients were included and 33 completed the study. NovaTears+Omega-3 (0.2%) showed clinically and statistically significant improvements in various clinical signs, such as total corneal staining, tear film break-up time, and Meibomian gland dysfunction (MGD) score, as well as in symptoms measured by Ocular Surface Disease Index (OSDI\n                      <jats:sup>\u00a9<\/jats:sup>\n                      ) and visual analog scales over the 8-week treatment period with change from baseline\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      values all &lt;0.0001. No worsening of any safety parameter (intraocular pressure, slit-lamp examination, visual acuity) was observed, and no adverse event was reported throughout the study.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>\n                      In this observational PMCF study, NovaTears+Omega-3 was safe and well tolerated. Treatment over an 8-week period resulted in significantly improved clinical signs and subjective symptoms in patients with evaporative dry eye. The study was registered at\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\">www.clinicaltrials.gov<\/jats:ext-link>\n                      (NCT04521465).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jop.2021.0102","type":"journal-article","created":{"date-parts":[[2022,5,4]],"date-time":"2022-05-04T17:14:22Z","timestamp":1651684462000},"page":"348-353","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":22,"title":["A Water-Free Omega-3 Fatty Acid Eye Drop Formulation for the Treatment of Evaporative Dry Eye Disease: A Prospective, Multicenter Noninterventional Study"],"prefix":"10.1177","volume":"38","author":[{"given":"Christina","family":"Jacobi","sequence":"first","affiliation":[{"name":"AUGEN &amp; HAUT Zentrum\u2014Praxis Dr. Jacobi, N\u00fcrnberg, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1133-6234","authenticated-orcid":false,"given":"Simone","family":"Angstmann-Mehr","sequence":"additional","affiliation":[{"name":"Novaliq GmbH, Heidelberg, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anja","family":"Lange","sequence":"additional","affiliation":[{"name":"Novaliq GmbH, Heidelberg, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Thomas","family":"Kaercher","sequence":"additional","affiliation":[{"name":"Augenarztpraxis, Heidelberg, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2022,6,9]]},"reference":[{"key":"e_1_3_3_2_2","doi-asserted-by":"publisher","DOI":"10.1097\/ICO.0b013e318225415a"},{"key":"e_1_3_3_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.011"},{"key":"e_1_3_3_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.01.006"},{"key":"e_1_3_3_5_2","doi-asserted-by":"publisher","DOI":"10.1097\/ICO.0000000000001884"},{"key":"e_1_3_3_6_2","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.16-19131"},{"key":"e_1_3_3_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2014.12.002"},{"key":"e_1_3_3_8_2","unstructured":"International Dry EyeWorkShop (DEWS). Ocular Surface 5 2007. www.tearfilm.org\/dewsreport\/pdfs\/TOS-0502-DEWS-noAds.pdf Accessed April22 2022."},{"key":"e_1_3_3_9_2","first-page":"500","article-title":"Antiinflammatory therapy for dry eye disease [in German]","volume":"229","author":"Steven P.","year":"2012","unstructured":"Steven P., , and Cursiefen C. Antiinflammatory therapy for dry eye disease [in German]. Klin Monatsbl\u00e4tter F\u00fcr Augenheilkd. 229:500\u2013505, 2012.","journal-title":"Klin Monatsbl\u00e4tter F\u00fcr Augenheilkd"},{"key":"e_1_3_3_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.neurol.2019.08.005"},{"key":"e_1_3_3_11_2","first-page":"CD011016","article-title":"Omega-3 and omega-6 polyunsaturated fatty acids for dry eye disease","volume":"12","author":"Downie L.E.","year":"2019","unstructured":"Downie L.E., , Ng S.M., , Lindsley K.B., et al. Omega-3 and omega-6 polyunsaturated fatty acids for dry eye disease. Cochrane Database Syst. 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