The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

Steven M Silverstein,1 Mitchell A Jackson,2 Damien F Goldberg,3 Mauricio Muñoz4On behalf of the Bromfenac Ophthalmic Solution 0.07% Once Daily Study Group1Silverstein Eye Centers, Kansas City, MO, USA; 2Jacksoneye, Inc., Lake Villa, IL, USA; 3Wolstan & Goldberg Eye Associates, To...

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Autores principales:	Silverstein SM, Jackson MA, Goldberg DF, Muñoz M
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/eb46aba2f04c46d0b93a6703d49aaf23
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spelling	oai:doaj.org-article:eb46aba2f04c46d0b93a6703d49aaf232021-12-02T07:37:15ZThe efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery1177-5483https://doaj.org/article/eb46aba2f04c46d0b93a6703d49aaf232014-05-01T00:00:00Zhttp://www.dovepress.com/the-efficacy-of-bromfenac-ophthalmic-solution-007-dosed-once-daily-in--a16886https://doaj.org/toc/1177-5483 Steven M Silverstein,1 Mitchell A Jackson,2 Damien F Goldberg,3 Mauricio Muñoz4On behalf of the Bromfenac Ophthalmic Solution 0.07% Once Daily Study Group1Silverstein Eye Centers, Kansas City, MO, USA; 2Jacksoneye, Inc., Lake Villa, IL, USA; 3Wolstan & Goldberg Eye Associates, Torrance, CA, USA; 4Bausch + Lomb, Irvine, CA, USAPurpose: To evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0–5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation.Methods: The study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with intraocular lens implantation (day −1) and again on the day of surgery (day 0) and for 14 days postoperatively. Follow-up was on days 1, 3, 8, and 15. The outcome measures included the percentage of subjects with zero-to-trace anterior chamber cells at each visit, as determined by the percentage of subjects with ≤5 anterior chamber cells, overall anterior chamber cell grades, and summed ocular inflammation score (SOIS) (combined anterior chamber cell and flare scores).Results: The proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 (P=0.0007), continued at day 8 (P<0.0001), and through day 15 (P<0.0001). At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects who did so in the placebo group. The overall anterior chamber cell scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). The SOIS were also significantly lower in the bromfenac group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit).Conclusion: Bromfenac ophthalmic solution 0.07%, dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and inflammation outcome measures.Keywords: ocular inflammation, anterior chamber inflammation, non-steroidal anti-inflammatory, cells and flareSilverstein SMJackson MAGoldberg DFMuñoz MDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2014, Iss default, Pp 965-972 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Silverstein SM Jackson MA Goldberg DF Muñoz M The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery
description	Steven M Silverstein,1 Mitchell A Jackson,2 Damien F Goldberg,3 Mauricio Muñoz4On behalf of the Bromfenac Ophthalmic Solution 0.07% Once Daily Study Group1Silverstein Eye Centers, Kansas City, MO, USA; 2Jacksoneye, Inc., Lake Villa, IL, USA; 3Wolstan & Goldberg Eye Associates, Torrance, CA, USA; 4Bausch + Lomb, Irvine, CA, USAPurpose: To evaluate the efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace (0–5 cells) anterior chamber cells, following cataract surgery with posterior chamber intraocular lens implantation.Methods: The study designed employed two Phase III, double-masked, placebo-controlled, multicenter clinical trials of 440 subjects, randomized to either bromfenac ophthalmic solution 0.07% (n=222) or placebo (n=218). Subjects self-dosed once daily, beginning 1 day before undergoing cataract surgery with intraocular lens implantation (day −1) and again on the day of surgery (day 0) and for 14 days postoperatively. Follow-up was on days 1, 3, 8, and 15. The outcome measures included the percentage of subjects with zero-to-trace anterior chamber cells at each visit, as determined by the percentage of subjects with ≤5 anterior chamber cells, overall anterior chamber cell grades, and summed ocular inflammation score (SOIS) (combined anterior chamber cell and flare scores).Results: The proportion of subjects with zero-to-trace anterior chamber cells was significantly higher in the bromfenac 0.07% group compared with the placebo group as early as day 3 (P=0.0007), continued at day 8 (P<0.0001), and through day 15 (P<0.0001). At day 15, 80.2% of subjects in the bromfenac 0.07% group achieved zero-to-trace anterior chamber cells compared with 47.2% of subjects who did so in the placebo group. The overall anterior chamber cell scores were significantly lower in the bromfenac 0.07% group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit). The SOIS were also significantly lower in the bromfenac group compared with the placebo group at days 3, 8, and 15 (P<0.0001 at each visit).Conclusion: Bromfenac ophthalmic solution 0.07%, dosed once daily was clinically effective in achieving zero-to-trace anterior chamber cell severity after cataract surgery and was superior to placebo in all anterior chamber cell severity and inflammation outcome measures.Keywords: ocular inflammation, anterior chamber inflammation, non-steroidal anti-inflammatory, cells and flare
format	article
author	Silverstein SM Jackson MA Goldberg DF Muñoz M
author_facet	Silverstein SM Jackson MA Goldberg DF Muñoz M
author_sort	Silverstein SM
title	The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery
title_short	The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery
title_full	The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery
title_fullStr	The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery
title_full_unstemmed	The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery
title_sort	efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/eb46aba2f04c46d0b93a6703d49aaf23
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The efficacy of bromfenac ophthalmic solution 0.07% dosed once daily in achieving zero-to-trace anterior chamber cell severity following cataract surgery

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