{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T20:23:15Z","timestamp":1788466995350,"version":"build-2803163510"},"reference-count":39,"publisher":"SAGE Publications","issue":"6","license":[{"start":{"date-parts":[[2016,3,8]],"date-time":"2016-03-08T00:00:00Z","timestamp":1457395200000},"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":["European Journal of Ophthalmology"],"published-print":{"date-parts":[[2016,11]]},"abstract":"<jats:sec>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of a preservative-free cationic emulsion (CE) with a 0.18% hyaluronate sodium (HS) solution in patients with moderate to severe dry eye disease (DED) with keratitis or keratoconjunctivitis.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Eighty-five patients were randomized (1:1) in this multicenter, prospective, reference-controlled, parallel-group, investigator-masked study to receive CE (n = 44) or HS (n = 41). Clinical signs and symptoms were assessed over 3 months. The primary efficacy endpoint was noninferiority of CE to HS in change from baseline of ocular surface staining (OSS) score at 1 month.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In the per protocol (PP) set and full analysis set (FAS), CE showed a similar and noninferior (p&lt;0.0001) improvement in OSS scores compared with HS at 1 month (PP: \u22122.5 \u00b1 1.3 vs \u22121.9 \u00b1 1.6; FAS: \u22122.2 \u00b1 1.5 vs \u22122.0 \u00b1 1.8 for CE vs HS). Other clinical signs of DED similarly improved in both groups. In the FAS, global symptoms score of ocular discomfort was significantly better with CE compared with HS at 1 month (-14.8 \u00b1 17.3 vs \u22127.6 \u00b1 14.2; p = 0.0469), including greater alleviation of itching (-14.8 \u00b1 21.2 vs \u22121.7 \u00b1 19.7; p = 0.0100) and eye dryness (-21.9 \u00b1 28.3 vs \u22128.4 \u00b1 21.4; p = 0.0016). Similar trends were observed at 3 months for itching and eye dryness. Investigator global efficacy assessment and quality of life scores for eye pain and driving favored CE at 3 months. Incidence of adverse events was low in both treatment groups.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>CE was similar to HS with regards to safety and efficacy for objective signs but was superior to HS in improving DED symptoms in patients with moderate to severe DED.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.5301\/ejo.5000830","type":"journal-article","created":{"date-parts":[[2016,8,12]],"date-time":"2016-08-12T05:11:17Z","timestamp":1470978677000},"page":"546-555","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":37,"title":["Efficacy and Safety of a Cationic Emulsion in the Treatment of Moderate to Severe Dry Eye Disease: A Randomized Controlled Study"],"prefix":"10.1177","volume":"26","author":[{"given":"Pierre-Yves","family":"Robert","sequence":"first","affiliation":[{"name":"Department of Ophthalmology, Dupuytren University Hospital, Limoges - France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"B\u00e9atrice","family":"Cochener","sequence":"additional","affiliation":[{"name":"Brest University Medical School, Department of Ophthalmology, Morvan Hospital, Brest - France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mourad","family":"Amrane","sequence":"additional","affiliation":[{"name":"Santen SAS, Evry - France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dahlia","family":"Ismail","sequence":"additional","affiliation":[{"name":"Santen SAS, Evry - France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jean-S\u00e9bastien","family":"Garrigue","sequence":"additional","affiliation":[{"name":"Santen SAS, Evry - France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pierre-Jean","family":"Pisella","sequence":"additional","affiliation":[{"name":"Fran\u00e7ois Rabelais University, Tours - France"},{"name":"Department of Ophthalmology, Bretonneau Hospital, Tours - France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"Baudouin","sequence":"additional","affiliation":[{"name":"Quinze-Vingts National Ophthalmology Hospital, Paris - France"},{"name":"UPMC University, Paris 6, Vision Institute, INSERM UMRS968, CNRS UMR7210, Paris - France"},{"name":"University of Versailles, Saint-Quentin en Yvelines, Versailles - France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"179","published-online":{"date-parts":[[2016,3,8]]},"reference":[{"key":"bibr1-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/S1542-0124(12)70081-2"},{"key":"bibr2-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/S1542-0124(12)70082-4"},{"key":"bibr3-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9394(03)00218-6"},{"key":"bibr4-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/S0181-5512(08)71431-1"},{"key":"bibr5-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1080\/09286580600801044"},{"issue":"4","key":"bibr6-ejo.5000830","first-page":"221","volume":"21","author":"Lemp MA","year":"1995","journal-title":"CLAO J"},{"key":"bibr7-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/S0181-5512(07)89584-2"},{"key":"bibr8-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajo.2008.05.016"},{"key":"bibr9-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1167\/iovs.10-6997f"},{"key":"bibr10-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/j.exer.2003.09.019"},{"key":"bibr11-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0050704"},{"key":"bibr12-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.2003.040022"},{"key":"bibr13-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/S1542-0124(12)70085-X"},{"key":"bibr14-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1159\/000310154"},{"key":"bibr15-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/S0161-6420(99)00513-8"},{"key":"bibr16-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/j.ajo.2005.05.001"},{"issue":"3","key":"bibr17-ejo.5000830","first-page":"192","volume":"6","author":"Javadi MA","year":"2011","journal-title":"J Ophthalmic Vis Res"},{"key":"bibr18-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/0039-6257(84)90168-1"},{"key":"bibr19-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1155\/2012\/604204"},{"key":"bibr20-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1097\/ICO.0b013e318165b19e"},{"key":"bibr21-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/S1350-9462(01)00017-9"},{"key":"bibr22-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1097\/ICO.0b013e31821b71e6"},{"key":"bibr23-ejo.5000830","first-page":"1797","volume":"7","author":"Qiao J","year":"2013","journal-title":"Clin Ophthalmol"},{"key":"bibr24-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1097\/01.icl.0000247638.50568.c0"},{"key":"bibr25-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S35833"},{"key":"bibr26-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1159\/000310224"},{"key":"bibr27-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1016\/j.jfo.2014.05.001"},{"issue":"246","key":"bibr28-ejo.5000830","volume":"89","author":"Aragona P","year":"2011","journal-title":"Acta Ophthalmol (Copenh)"},{"key":"bibr29-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-200310000-00008"},{"key":"bibr30-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1159\/000027387"},{"key":"bibr31-ejo.5000830","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.2005.073916"},{"issue":"6","key":"bibr32-ejo.5000830","first-page":"412","volume":"35","author":"Baeyens V","year":"2012","journal-title":"Efficacy of 0.18% hypotonic sodium hyaluronate ophthalmic solution in the treatment of signs and symptoms of dry eye disease. 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