{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,1]],"date-time":"2025-11-01T08:42:39Z","timestamp":1761986559100},"reference-count":53,"publisher":"Oceanside Publications Inc.","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["allergy asthma proc"],"published-print":{"date-parts":[[2022,1,9]]},"abstract":"<jats:p><jats:bold>Background:<\/jats:bold> Intranasal corticosteroids (INCS) are the cornerstone of treatment for chronic rhinosinusitis. Although INCS are generally considered safe and effective, there is a concern that chronic use may lead to ocular adverse effects.  <jats:bold>Objective:<\/jats:bold> To\n assess ocular safety of the exhalation delivery system with fluticasone propionate (EDS-FLU) in patients with chronic rhinosinusitis with nasal polyps.  <jats:bold>Methods:<\/jats:bold> Ocular safety data were collected during two randomized, double-blind, placebo controlled studies with open-label\n extensions. Ophthalmologists performed tonometry, slit-lamp, and visual acuity examinations to assess intraocular pressure (IOP) and the presence of cataracts. Ocular examinations were conducted before double-blind treatment, at the end of the 16-week double-blind phase, and at the end of\n the 8-week open-label phase. The results of pooled data from patients who received EDS-FLU 186 \u00b5g (n = 160), EDS-FLU 372 \u00b5g (n = 161), and EDS-placebo (n = 161) twice daily are reported here.  <jats:bold>Results:<\/jats:bold> At the end of the double-blind phase, six patients developed\n elevated average IOP &gt; 21 mm Hg: two patients (1.2%) in the EDS-placebo group, three patients (1.9%) in the EDS-FLU 186 \u00b5g group, and one patient (0.6%) in the EDS-FLU 372 \u00b5g group. In addition, 6 of 482 patients developed cataracts: 3 patients in the EDS-placebo group, 2 patients\n in the EDS-FLU 186 \u00b5g group, and 1 patient in the EDS-FLU 372 \u00b5g group. At the end of the open-label phase, two additional patients showed IOP &gt; 21 mm Hg and two additional patients developed cataracts.  <jats:bold>Conclusion:<\/jats:bold> No increased risk of elevated IOP was detected\n with EDS-FLU; the rate of cataract development was similar to EDS-placebo and to that reported with other INCS.Clinical trials NCT01622569 and NCT01624662, &lt;ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"http:\/\/www.clinicaltrials.gov\"&gt;www.clinicaltrials.gov&lt;\/ext-link&gt;<\/jats:p>","DOI":"10.2500\/aap.2022.43.210096","type":"journal-article","created":{"date-parts":[[2021,11,10]],"date-time":"2021-11-10T01:05:26Z","timestamp":1636506326000},"page":"70-77","source":"Crossref","is-referenced-by-count":3,"title":["Evaluation of the ocular safety associated with the exhalation delivery system with fluticasone"],"prefix":"10.2500","volume":"43","author":[{"given":"David P.","family":"Skoner","sequence":"first","affiliation":[{"name":"From the Director, Section of Allergy and Immunology, West Virginia University Children's Hospital, Morgantown, West Virginia;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eli O.","family":"Meltzer","sequence":"additional","affiliation":[{"name":"Clinical Professor, Department of Pediatrics, Division of Allergy\/Immunology, University of California San Diego School of Medicine, San Diego, California;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan","family":"Skoner","sequence":"additional","affiliation":[{"name":"Ortho Eyes, Pittsburgh, Pennsylvania;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Harry J.","family":"Sacks","sequence":"additional","affiliation":[{"name":"Medical Affairs, OptiNose US, Inc., Yardley, Pennsylvania;"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William R.","family":"Lumry","sequence":"additional","affiliation":[{"name":"Clinical Professor, Department of Internal Medicine, University of Texas Southwestern Medical School, Dallas, Texas; 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