Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery

Timothy L Comstock1 Michael R Paterno1 Angele Singh1 Tara Erb1 Elizabeth Davis21Bausch and Lomb Inc., Rochester, NY, USA; 2Minnesota Eye Consultants, Bloomington, MN, USABackground: To compare the safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% (LE ointment), a new topical oint...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Timothy L Comstock, Michael R Paterno, Angele Singh, et al
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2011
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/ab92cd3cc6ee4e779872febd40028976
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:ab92cd3cc6ee4e779872febd40028976
record_format	dspace
spelling	oai:doaj.org-article:ab92cd3cc6ee4e779872febd400289762021-12-02T01:07:08ZSafety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery1177-54671177-5483https://doaj.org/article/ab92cd3cc6ee4e779872febd400289762011-02-01T00:00:00Zhttp://www.dovepress.com/safety-and-efficacy-of-loteprednol-etabonate-ophthalmic-ointment-05-fo-a6275https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Timothy L Comstock1 Michael R Paterno1 Angele Singh1 Tara Erb1 Elizabeth Davis21Bausch and Lomb Inc., Rochester, NY, USA; 2Minnesota Eye Consultants, Bloomington, MN, USABackground: To compare the safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% (LE ointment), a new topical ointment formulation, with vehicle for the treatment of inflammation and pain following cataract surgery.Methods: Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies were conducted. Patients aged &ge;18 years with a combined postoperative anterior chamber cells and flare (ACI) &ge; Grade 3 following uncomplicated cataract surgery participated in seven study visits. Patients self-administered either topical LE ointment or vehicle four times daily for 14 days. Efficacy outcomes included the proportion of patients with complete resolution of ACI and the proportion of patients with no (Grade 0) pain at postoperative day 8. Safety outcomes included the incidence of adverse events, ocular symptoms, changes in intraocular pressure and visual acuity, and biomicroscopy and funduscopy findings.Results: Data from the two studies were combined. The integrated intent-to-treat population consisted of 805 patients (mean [standard deviation] age 69.0 [9.2] years; 58.0% female and 89.7% white). Significantly more LE ointment-treated patients than vehicle-treated patients had complete resolution of ACI (27.7% versus 12.5%) and no pain (75.5% versus 43.1%) at day 8 (P &lt; 0.0001 for both). Fewer LE ointment-treated patients required rescue medication (27.7% versus 63.8%), and fewer had an ocular adverse event (47.2% versus 78.0%, P &lt; 0.0001) while on study treatment. The most common ocular adverse events with LE ointment were anterior chamber inflammation, photophobia, corneal edema, conjunctival hyperemia, eye pain, and iritis. Mean intraocular pressure decreased in both treatment groups. Four patients had increased intraocular pressure &ge;10 mmHg (three LE ointment and one vehicle) prior to rescue medication. Visual acuity and dilated funduscopy results were similar between the treatment groups, with the exception of visual acuity at visits 5 and 6, which favored LE ointment.Conclusion: LE ointment was efficacious and well tolerated in the treatment of ocular inflammation and pain following cataract surgery.Keywords: loteprednol etabonate, ophthalmic ointment, postoperative inflammation, postoperative pain, cataract surgery, intraocular pressure Timothy L ComstockMichael R PaternoAngele Singhet alDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2011, Iss default, Pp 177-186 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Timothy L Comstock Michael R Paterno Angele Singh et al Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery
description	Timothy L Comstock1 Michael R Paterno1 Angele Singh1 Tara Erb1 Elizabeth Davis21Bausch and Lomb Inc., Rochester, NY, USA; 2Minnesota Eye Consultants, Bloomington, MN, USABackground: To compare the safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% (LE ointment), a new topical ointment formulation, with vehicle for the treatment of inflammation and pain following cataract surgery.Methods: Two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies were conducted. Patients aged &ge;18 years with a combined postoperative anterior chamber cells and flare (ACI) &ge; Grade 3 following uncomplicated cataract surgery participated in seven study visits. Patients self-administered either topical LE ointment or vehicle four times daily for 14 days. Efficacy outcomes included the proportion of patients with complete resolution of ACI and the proportion of patients with no (Grade 0) pain at postoperative day 8. Safety outcomes included the incidence of adverse events, ocular symptoms, changes in intraocular pressure and visual acuity, and biomicroscopy and funduscopy findings.Results: Data from the two studies were combined. The integrated intent-to-treat population consisted of 805 patients (mean [standard deviation] age 69.0 [9.2] years; 58.0% female and 89.7% white). Significantly more LE ointment-treated patients than vehicle-treated patients had complete resolution of ACI (27.7% versus 12.5%) and no pain (75.5% versus 43.1%) at day 8 (P &lt; 0.0001 for both). Fewer LE ointment-treated patients required rescue medication (27.7% versus 63.8%), and fewer had an ocular adverse event (47.2% versus 78.0%, P &lt; 0.0001) while on study treatment. The most common ocular adverse events with LE ointment were anterior chamber inflammation, photophobia, corneal edema, conjunctival hyperemia, eye pain, and iritis. Mean intraocular pressure decreased in both treatment groups. Four patients had increased intraocular pressure &ge;10 mmHg (three LE ointment and one vehicle) prior to rescue medication. Visual acuity and dilated funduscopy results were similar between the treatment groups, with the exception of visual acuity at visits 5 and 6, which favored LE ointment.Conclusion: LE ointment was efficacious and well tolerated in the treatment of ocular inflammation and pain following cataract surgery.Keywords: loteprednol etabonate, ophthalmic ointment, postoperative inflammation, postoperative pain, cataract surgery, intraocular pressure
format	article
author	Timothy L Comstock Michael R Paterno Angele Singh et al
author_facet	Timothy L Comstock Michael R Paterno Angele Singh et al
author_sort	Timothy L Comstock
title	Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery
title_short	Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery
title_full	Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery
title_fullStr	Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery
title_full_unstemmed	Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery
title_sort	safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery
publisher	Dove Medical Press
publishDate	2011
url	https://doaj.org/article/ab92cd3cc6ee4e779872febd40028976
work_keys_str_mv	AT timothylcomstock safetyandefficacyofloteprednoletabonateophthalmicointment05forthetreatmentofinflammationandpainfollowingcataractsurgery AT michaelrpaterno safetyandefficacyofloteprednoletabonateophthalmicointment05forthetreatmentofinflammationandpainfollowingcataractsurgery AT angelesingh safetyandefficacyofloteprednoletabonateophthalmicointment05forthetreatmentofinflammationandpainfollowingcataractsurgery AT etal safetyandefficacyofloteprednoletabonateophthalmicointment05forthetreatmentofinflammationandpainfollowingcataractsurgery
_version_	1718403337899999232

Safety and efficacy of loteprednol etabonate ophthalmic ointment 0.5% for the treatment of inflammation and pain following cataract surgery

Ejemplares similares