{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,25]],"date-time":"2026-05-25T06:04:26Z","timestamp":1779689066365,"version":"3.53.1"},"reference-count":30,"publisher":"BMJ","issue":"5","license":[{"start":{"date-parts":[[2026,5,22]],"date-time":"2026-05-22T00:00:00Z","timestamp":1779408000000},"content-version":"unspecified","delay-in-days":21,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Laboratorios Salvat, S.A."}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2026,3,26]]},"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>To assess the effect of clobetasol propionate ophthalmic nanoemulsion, 0.05% (clobetasol) on ocular inflammation and eye pain associated with cataract surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>Two independent twin phase 3 multicentre, randomised, parallel-group, double-masked, placebo-controlled clinical studies.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Setting<\/jats:title>\n                    <jats:p>The CLOSE-1 and the CLOSE-2 trials, respectively, involved 19 and 17 sites in the USA.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>Patients who presented inflammation of at least five cells in the anterior chamber on the first day after routine unilateral cataract surgery<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Interventions<\/jats:title>\n                    <jats:p>Participants were randomised to either clobetasol or placebo four times a day for 14 days. Follow-up visits occurred on days 3, 8, 15 and 29.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>The primary endpoint was the proportion of patients with anterior chamber cell (ACC) grade 0 on day 8. A key secondary efficacy endpoint was the proportion of patients with a Visual Analogue Scale (VAS) pain score of 0 on day 8. Safety was also assessed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>426 patients were randomised: 281 to the clobetasol arm and 145 to the placebo arm. The proportion of patients with ACC of 0 at day 8 was significantly superior with clobetasol (37.8% vs 18.1%; odds ratio [OR] 2.8; p&lt;0.0001). The percentage of patients with a VAS pain score of 0 on day 8 was greater with clobetasol (54.7% vs 36.5%; OR 2.1; p=0.0005). Related treatment-emergent adverse events were reported in 3.9% of patients on clobetasol and 5.5% on placebo.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Clobetasol propionate ophthalmic nanoemulsion 0.05% is an effective and safe therapeutic option for treating inflammation and pain associated with cataract surgery.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration numbers<\/jats:title>\n                    <jats:p>\n                      CLOSE-1 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04246801\">NCT04246801<\/jats:ext-link>\n                      ) and CLOSE-2 (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04249076\">NCT04249076<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2025-101177","type":"journal-article","created":{"date-parts":[[2026,5,25]],"date-time":"2026-05-25T05:40:19Z","timestamp":1779687619000},"page":"e101177","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of clobetasol propionate ophthalmic nanoemulsion for treating intraocular inflammation and pain associated with cataract surgery: two phase 3 multicentre, randomised, placebo-controlled, double-masked clinical studies"],"prefix":"10.1136","volume":"16","clinical-trial-number":[{"clinical-trial-number":"nct04246801","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04249076","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04246801","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct04249076","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Andrew","family":"Schwartz","sequence":"first","affiliation":[{"name":"Fifth Avenue Eye Associates, New York, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kent","family":"Wellish","sequence":"additional","affiliation":[{"name":"Wellish Vision Institute, Las Vegas, Nevada, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fiaz","family":"Zaman","sequence":"additional","affiliation":[{"name":"Houston Eye Associates, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin","family":"Jong","sequence":"additional","affiliation":[{"name":"Houston Eye Associates, Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ehsan","family":"Sadri","sequence":"additional","affiliation":[{"name":"Visionary Eye Institute, Newport Beach, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph","family":"Martel","sequence":"additional","affiliation":[{"name":"Martel Medical Eye Group, Rancho Cordova, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Peace","sequence":"additional","affiliation":[{"name":"United Medical Research Institute, Inglewood, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Korenfeld","sequence":"additional","affiliation":[{"name":"Comprehensive Eye Care Ltd, Washington, Missouri, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2026,5,24]]},"reference":[{"key":"2026052422401162000_16.5.e101177.1","doi-asserted-by":"publisher","DOI":"10.1136\/bjophthalmol-2011-300539"},{"key":"2026052422401162000_16.5.e101177.2","unstructured":"Friedman D , O\u2019Colmain B , Mestril I . 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