{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T15:53:15Z","timestamp":1777909995139,"version":"3.51.4"},"reference-count":33,"publisher":"SAGE Publications","issue":"9","license":[{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2022,11,1]],"date-time":"2022-11-01T00:00:00Z","timestamp":1667260800000},"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":[[2022,11,1]]},"abstract":"<jats:sec>\n                    <jats:title>\n                      <jats:italic toggle=\"yes\">Purpose<\/jats:italic>\n                      :\n                    <\/jats:title>\n                    <jats:p>To compare the performance and safety of 2 tear substitutes containing sodium hyaluronate (SH); one containing 0.15% SH and polyethylene glycol (PEG) 8000, and the other containing 0.18% SH.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      <jats:italic toggle=\"yes\">:<\/jats:italic>\n                      In this multicenter, randomized, investigator-masked, noninferiority trial, 83 patients with moderate or severe dry eye disease underwent a 2-week washout, and were then randomly assigned (1:1) to receive SH plus PEG tear substitute (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200945) or comparator SH tear substitute (\n                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u200938) 3\u20136 times daily for 3 months. The primary performance endpoint was the change from baseline in the ocular surface fluorescein staining (OSFS) score on day 28 in the per-protocol (PP) population, according to the 15-point Oxford Scheme, with a noninferiority margin of 2.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      Both groups improved significantly in terms of signs and symptoms. Among the 78 patients without major protocol deviations (the PP population), the OSFS score decreased by 2.9\u2009\u00b1\u20092.0 on day 28 from 5.4\u2009\u00b1\u20091.3 at baseline in the SH plus PEG group and by 2.3\u2009\u00b1\u20092.2 from 5.2\u2009\u00b1\u20091.4 in the comparator group (95% confidence interval of the difference: \u22121.2 to 0.3), demonstrating noninferiority. On day 90, the improvement in OSFS scores was significantly greater in the SH plus PEG group (\n                      <jats:italic toggle=\"yes\">P<\/jats:italic>\n                      \u2009=\u20090.0002). The safety profiles were satisfactory in both groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion:<\/jats:title>\n                    <jats:p>\n                      SH plus PEG tear substitute was noninferior to SH tear substitute in the studied population and may provide additional benefits in the long term.\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/ClinicalTrials.gov\">ClinicalTrials.gov<\/jats:ext-link>\n                      ID: NCT02975102.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jop.2022.0048","type":"journal-article","created":{"date-parts":[[2022,10,21]],"date-time":"2022-10-21T12:43:23Z","timestamp":1666356203000},"page":"607-616","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":7,"title":["Performance and Safety of a Sodium Hyaluronate Tear Substitute with Polyethylene Glycol in Dry Eye Disease: A Multicenter, Investigator-Masked, Randomized, Noninferiority Trial"],"prefix":"10.1177","volume":"38","author":[{"given":"Marc","family":"Labetoulle","sequence":"first","affiliation":[{"name":"Service d'Ophtalmologie, H\u00f4pital Bic\u00eatre, APHP, Universit\u00e9 Paris Sud, Le Kremlin-Bic\u00eatre, France."},{"name":"IDMIT Infrastructure, CEA, Universit\u00e9 Paris-Saclay, Inserm U1184, Fontenay-aux-Roses, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the CBL-101 Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruno","family":"Mortemousque","sequence":"additional","affiliation":[{"name":"Cabinet Ophtalmologie Foch, Bordeaux, France."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"J\u00e9r\u00f4me","family":"Allali","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Blanc","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maxence","family":"Bonne","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean-Michel","family":"Bosc","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Thierry","family":"Bury","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Chr\u00e9tien-Malinconi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Virginie","family":"Cozon-Devred","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pierre","family":"Gabisson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Didier","family":"Hoa","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marc","family":"Labetoulle","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruno","family":"Mortemousque","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aurore","family":"Muselier-Mathieu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Philippe","family":"Partouche","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Rocher","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Sabadel","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Benjamin","family":"Nyst","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gauthier","family":"Schepens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ru-Yin","family":"Yeh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2022,11,8]]},"reference":[{"key":"e_1_3_7_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.005"},{"key":"e_1_3_7_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.003"},{"key":"e_1_3_7_4_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12886-016-0364-4"},{"key":"e_1_3_7_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.008"},{"key":"e_1_3_7_6_2","doi-asserted-by":"publisher","DOI":"10.1136\/bjophthalmol-2013-304619"},{"key":"e_1_3_7_7_2","first-page":"205","article-title":"survey","volume":"107","author":"Asbell PA","year":"2009","unstructured":"Asbell PA, , Spiegel S. Ophthalmologist perceptions regarding treatment of moderate to severe dry eye: Results of a physician survey. Trans Am Ophthalmol Soc, 107:205\u2013210, 2009.","journal-title":"Trans Am Ophthalmol Soc"},{"key":"e_1_3_7_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtos.2017.05.006"},{"key":"e_1_3_7_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2018.10.023"},{"issue":"17","key":"e_1_3_7_10_2","first-page":"8642","article-title":"Dry eye disease treatment: The role of tear substitutes, their future, and an updated classification","volume":"24","author":"Barabino S","year":"2020","unstructured":"Barabino S, , Benitez-Del-Castillo JM, , Fuchsluger T, et al. Dry eye disease treatment: The role of tear substitutes, their future, and an updated classification. Eur Rev Med Pharmacol Sci, 2020; 24(17):8642\u20138652; doi: 10.26355\/eurrev_202009_22801","journal-title":"Eur Rev Med Pharmacol Sci"},{"key":"e_1_3_7_11_2","doi-asserted-by":"publisher","DOI":"10.3390\/ijms23052434"},{"key":"e_1_3_7_12_2","unstructured":"Baudouin C Rousseau A Hassani TJ et al. Strat\u00e9gies th\u00e9rapeutiques dans la s\u00e9cheresse oculaire. In: Surface Oculaire. (Soci\u00e9t\u00e9 Fran\u00e7aise d'Ophtalmologie. eds.) Elsevier Masson SAS.: France; 2015; pp. 631\u2013642."},{"key":"e_1_3_7_13_2","doi-asserted-by":"publisher","DOI":"10.35119\/myjo.v2i2.109"},{"key":"e_1_3_7_14_2","doi-asserted-by":"publisher","DOI":"10.1007\/978-1-4615-5359-5_110"},{"key":"e_1_3_7_15_2","first-page":"S848","article-title":"Hyaluronic acid concentration in human tear fluids","volume":"37","author":"Fukuda M","year":"1996","unstructured":"Fukuda M, , Miyamoto Y, , Miyara Y, et al. Hyaluronic acid concentration in human tear fluids. Invest Ophthalmol Vis Sci, 1996; 37(Suppl):S848.","journal-title":"Invest Ophthalmol Vis Sci"},{"key":"e_1_3_7_16_2","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-199309000-00010"},{"key":"e_1_3_7_17_2","doi-asserted-by":"publisher","DOI":"10.1038\/eye.1990.83"},{"key":"e_1_3_7_18_2","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-199207000-00003"},{"key":"e_1_3_7_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/0378-5173(89)90193-2"},{"key":"e_1_3_7_20_2","unstructured":"Wallick D. Polyethylene Glycol. In: The Handbook of Pharmaceutical Excipients 6th edn. (Rowe RC Sheskey PJ Quinn ME eds.) DC and Pharmaceutical Press: London; 2009; pp. 517\u2013522."},{"key":"e_1_3_7_21_2","first-page":"6000","article-title":"Corneal epithelial cell protective and wettability-enhancing properties of hyaluronic acid + PEG 8000 in an artificial tear product. ARVO Annual Meeting Abstract","volume":"54","author":"Davio S","year":"2013","unstructured":"Davio S, , Cavet M, , Harrington K, et al. Corneal epithelial cell protective and wettability-enhancing properties of hyaluronic acid + PEG 8000 in an artificial tear product. ARVO Annual Meeting Abstract. Invest Ophthalmol Vis Sci, 2013; 54:6000.","journal-title":"Invest Ophthalmol Vis Sci"},{"key":"e_1_3_7_22_2","doi-asserted-by":"publisher","DOI":"10.5301\/ejo.5000267"},{"key":"e_1_3_7_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jfo.2011.07.017"},{"key":"e_1_3_7_24_2","doi-asserted-by":"publisher","DOI":"10.5301\/ejo.5000117"},{"key":"e_1_3_7_25_2","doi-asserted-by":"publisher","DOI":"10.1038\/eye.2017.73"},{"key":"e_1_3_7_26_2","doi-asserted-by":"publisher","DOI":"10.2147\/OPTH.S131384"},{"key":"e_1_3_7_27_2","doi-asserted-by":"publisher","DOI":"10.5301\/ejo.5000836"},{"key":"e_1_3_7_28_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0181-5512(08)71431-1"},{"key":"e_1_3_7_29_2","doi-asserted-by":"publisher","DOI":"10.1089\/jop.2016.0086"},{"key":"e_1_3_7_30_2","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.2003.027573"},{"key":"e_1_3_7_31_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1542-0124(12)70084-8"},{"key":"e_1_3_7_32_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.survophthal.2007.04.009"},{"key":"e_1_3_7_33_2","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-200310000-00008"},{"key":"e_1_3_7_34_2","doi-asserted-by":"publisher","DOI":"10.1038\/eye.2000.244"}],"container-title":["Journal of Ocular Pharmacology and Therapeutics"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/jop.2022.0048","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jop.2022.0048","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jop.2022.0048","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T14:45:12Z","timestamp":1777646712000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/jop.2022.0048"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,11,1]]},"references-count":33,"journal-issue":{"issue":"9","published-print":{"date-parts":[[2022,11,1]]}},"alternative-id":["10.1089\/jop.2022.0048"],"URL":"https:\/\/doi.org\/10.1089\/jop.2022.0048","relation":{},"ISSN":["1080-7683","1557-7732"],"issn-type":[{"value":"1080-7683","type":"print"},{"value":"1557-7732","type":"electronic"}],"subject":[],"published":{"date-parts":[[2022,11,1]]}}}