Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial

Raymond Fong,1 Martin Leitritz,2 Raphaele Siou-Mermet,3 Tara Erb41Manhattan Eye, Ear and Throat Hospital, Lenox Hill Hospital, New York, NY, USA; 2Department of Ophthalmology, University Eye Hospital T&uuml;bingen, University of T&uuml;bingen, T&uuml;bingen, Germany; 3Bausch...

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Autores principales:	Fong R, Leitritz M, Siou-Mermet R, Erb T
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2012
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/e09c161566314bc59b2eedc509e926f2
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spelling	oai:doaj.org-article:e09c161566314bc59b2eedc509e926f22021-12-02T06:35:00ZLoteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial1177-54671177-5483https://doaj.org/article/e09c161566314bc59b2eedc509e926f22012-07-01T00:00:00Zhttp://www.dovepress.com/loteprednol-etabonate-gel-05-for-postoperative-pain-and-inflammation-a-a10434https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Raymond Fong,1 Martin Leitritz,2 Raphaele Siou-Mermet,3 Tara Erb41Manhattan Eye, Ear and Throat Hospital, Lenox Hill Hospital, New York, NY, USA; 2Department of Ophthalmology, University Eye Hospital T&uuml;bingen, University of T&uuml;bingen, T&uuml;bingen, Germany; 3Bausch and Lomb, Montpellier, France; 4Bausch and Lomb, Rochester, NY, USAPurpose: Loteprednol etabonate (LE) is approved by the US FDA in a suspension and ointment form (0.5%) for the treatment of postoperative ocular inflammation. This study examined the gel formulation of LE, an improved, nonsettling formulation with a lower preservative level and a more physiologic pH.Patients and methods: This multicenter, double-masked, parallel-group, vehicle-controlled study randomized patients aged &ge;18 years with postoperative anterior chamber cell (ACC) &ge; grade 2 following uncomplicated cataract surgery to either LE gel or vehicle four times a day for 14 days. Primary efficacy end points included the proportion of patients with complete resolution of ACC and grade 0 (no) pain by postoperative day 8. Secondary efficacy end points included complete resolution and change from baseline in ACC and flare (individual and combined), and grade 0 pain at each visit. Safety end points included treatment-emergent adverse events, ocular symptoms, changes in intraocular pressure (IOP) and visual acuity, and biomicroscopy and funduscopy findings.Results: A total of 407 patients were randomized to treatment (n = 206, LE gel; n = 201, vehicle). At day 8, 31.1% (64) of LE-treated patients and 13.9% (28) of vehicle-treated patients had complete resolution of ACC (P &lt; 0.001), and 75.7% (156) of LE-treated patients and 45.8% (92) of vehicle-treated patients had grade 0 pain (P &lt; 0.001). Secondary efficacy end points also favored LE gel. Fewer patients treated with LE gel required rescue medication (10.7% versus 42.3%) prior to day 15, and fewer had an ocular adverse event (16.0% versus 28.9%, P = 0.002). No drug-related adverse effects were reported more than once in the LE group. Mean IOP decreased in both treatment groups; one patient in the LE group demonstrated a clinically significant increase (&ge;10 mm Hg) in IOP that was not considered drug-related. Visual acuity and funduscopy findings were similar between treatments.Conclusion: LE gel 0.5% was efficacious and safe in treating postoperative inflammation and pain in this clinical study.Keywords: cataract surgery, corticosteroids, gel, loteprednol etabonate, postoperative inflammation, postoperative painFong RLeitritz MSiou-Mermet RErb TDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2012, Iss default, Pp 1113-1124 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Fong R Leitritz M Siou-Mermet R Erb T Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial
description	Raymond Fong,1 Martin Leitritz,2 Raphaele Siou-Mermet,3 Tara Erb41Manhattan Eye, Ear and Throat Hospital, Lenox Hill Hospital, New York, NY, USA; 2Department of Ophthalmology, University Eye Hospital T&uuml;bingen, University of T&uuml;bingen, T&uuml;bingen, Germany; 3Bausch and Lomb, Montpellier, France; 4Bausch and Lomb, Rochester, NY, USAPurpose: Loteprednol etabonate (LE) is approved by the US FDA in a suspension and ointment form (0.5%) for the treatment of postoperative ocular inflammation. This study examined the gel formulation of LE, an improved, nonsettling formulation with a lower preservative level and a more physiologic pH.Patients and methods: This multicenter, double-masked, parallel-group, vehicle-controlled study randomized patients aged &ge;18 years with postoperative anterior chamber cell (ACC) &ge; grade 2 following uncomplicated cataract surgery to either LE gel or vehicle four times a day for 14 days. Primary efficacy end points included the proportion of patients with complete resolution of ACC and grade 0 (no) pain by postoperative day 8. Secondary efficacy end points included complete resolution and change from baseline in ACC and flare (individual and combined), and grade 0 pain at each visit. Safety end points included treatment-emergent adverse events, ocular symptoms, changes in intraocular pressure (IOP) and visual acuity, and biomicroscopy and funduscopy findings.Results: A total of 407 patients were randomized to treatment (n = 206, LE gel; n = 201, vehicle). At day 8, 31.1% (64) of LE-treated patients and 13.9% (28) of vehicle-treated patients had complete resolution of ACC (P &lt; 0.001), and 75.7% (156) of LE-treated patients and 45.8% (92) of vehicle-treated patients had grade 0 pain (P &lt; 0.001). Secondary efficacy end points also favored LE gel. Fewer patients treated with LE gel required rescue medication (10.7% versus 42.3%) prior to day 15, and fewer had an ocular adverse event (16.0% versus 28.9%, P = 0.002). No drug-related adverse effects were reported more than once in the LE group. Mean IOP decreased in both treatment groups; one patient in the LE group demonstrated a clinically significant increase (&ge;10 mm Hg) in IOP that was not considered drug-related. Visual acuity and funduscopy findings were similar between treatments.Conclusion: LE gel 0.5% was efficacious and safe in treating postoperative inflammation and pain in this clinical study.Keywords: cataract surgery, corticosteroids, gel, loteprednol etabonate, postoperative inflammation, postoperative pain
format	article
author	Fong R Leitritz M Siou-Mermet R Erb T
author_facet	Fong R Leitritz M Siou-Mermet R Erb T
author_sort	Fong R
title	Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial
title_short	Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial
title_full	Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial
title_fullStr	Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial
title_full_unstemmed	Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial
title_sort	loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial
publisher	Dove Medical Press
publishDate	2012
url	https://doaj.org/article/e09c161566314bc59b2eedc509e926f2
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Loteprednol etabonate gel 0.5% for postoperative pain and inflammation after cataract surgery: results of a multicenter trial

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