Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension

Jess T Whitson,1 Tony Realini,2 Quang H Nguyen,3 Matthew G McMenemy,4 Stephen M Goode5 1University of Texas Southwestern Medical Center at Dallas, Dallas, TX, 2West Virginia University Eye Institute, Morgantown, WV, 3Scripps Clinic, La Jolla, CA, 4Lone Star Eye Care, Sugar Land, TX, 5Alcon Research...

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Autores principales:	Whitson JT, Realini T, Nguyen QH, McMenemy MG, Goode SM
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2013
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/340614ab35254b5092eff1a93ff4728a
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spelling	oai:doaj.org-article:340614ab35254b5092eff1a93ff4728a2021-12-02T00:48:52ZSix-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension1177-54671177-5483https://doaj.org/article/340614ab35254b5092eff1a93ff4728a2013-06-01T00:00:00Zhttp://www.dovepress.com/six-month-results-from-a-phase-iii-randomized-trial-of-fixed-combinati-a13262https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483Jess T Whitson,1 Tony Realini,2 Quang H Nguyen,3 Matthew G McMenemy,4 Stephen M Goode5 1University of Texas Southwestern Medical Center at Dallas, Dallas, TX, 2West Virginia University Eye Institute, Morgantown, WV, 3Scripps Clinic, La Jolla, CA, 4Lone Star Eye Care, Sugar Land, TX, 5Alcon Research Ltd, Fort Worth, TX, USA Background: The objective of this study was to examine the safety and intraocular pressure (IOP)-lowering efficacy of a fixed combination of brinzolamide 1% + brimonidine 0.2% (BBFC) after six months of treatment in patients with open-angle glaucoma or ocular hypertension. Methods: This was a randomized, multicenter, double-masked, three-month, three-arm contribution-of-elements study with a three-month safety extension. Patients were randomly assigned 1:1:1 to treatment with BBFC, brinzolamide 1%, or brimonidine 0.2% after a washout period. Patients dosed their study medications three times daily at 8 am, 3 pm, and 10 pm for six months. Patients returned for visits at two weeks, six weeks, three months, and six months. IOP measurements were used to assess efficacy. Safety assessments were adverse events, corrected distance visual acuity, slit-lamp biomicroscopy, pachymetry, perimetry, fundus parameters, and cardiac parameters. Results: A total of 690 patients were randomized. Six-month mean IOP values were similar to those at three months, when the mean IOP in patients treated with BBFC was significantly lower than that of either monotherapy group. A total of 175 patients experienced at least one treatment-related adverse event (BBFC, 33.0%; brinzolamide, 18.8%; brimonidine, 24.7%), eight of which were severe, and five resulted in discontinuation. Seventy-seven patients discontinued participation due to treatment-related adverse events (BBFC, 17.2%; brinzolamide, 2.1%; brimonidine, 14.5%). There were 21 serious adverse events (n = 7 in each group), none of which was related to treatment. Resting mean pulse and blood pressure with BBFC were similar to those with brimonidine, demonstrating modest, clinically insignificant decreases. No new or increased risks were identified with use of BBFC relative to either monotherapy. Conclusion: This study showed that, after six months of treatment, the safety profile of BBFC was similar to that of its individual components and its IOP-lowering activity was similar to its efficacy at three months, when it was superior to both brinzolamide 1% alone and brimonidine 0.2% alone. Keywords: brimonidine, brinzolamide, fixed combination, ocular hypertension, open-angle glaucomaWhitson JTRealini TNguyen QHMcMenemy MGGoode SMDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2013, Iss default, Pp 1053-1060 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 Whitson JT Realini T Nguyen QH McMenemy MG Goode SM Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension
description	Jess T Whitson,1 Tony Realini,2 Quang H Nguyen,3 Matthew G McMenemy,4 Stephen M Goode5 1University of Texas Southwestern Medical Center at Dallas, Dallas, TX, 2West Virginia University Eye Institute, Morgantown, WV, 3Scripps Clinic, La Jolla, CA, 4Lone Star Eye Care, Sugar Land, TX, 5Alcon Research Ltd, Fort Worth, TX, USA Background: The objective of this study was to examine the safety and intraocular pressure (IOP)-lowering efficacy of a fixed combination of brinzolamide 1% + brimonidine 0.2% (BBFC) after six months of treatment in patients with open-angle glaucoma or ocular hypertension. Methods: This was a randomized, multicenter, double-masked, three-month, three-arm contribution-of-elements study with a three-month safety extension. Patients were randomly assigned 1:1:1 to treatment with BBFC, brinzolamide 1%, or brimonidine 0.2% after a washout period. Patients dosed their study medications three times daily at 8 am, 3 pm, and 10 pm for six months. Patients returned for visits at two weeks, six weeks, three months, and six months. IOP measurements were used to assess efficacy. Safety assessments were adverse events, corrected distance visual acuity, slit-lamp biomicroscopy, pachymetry, perimetry, fundus parameters, and cardiac parameters. Results: A total of 690 patients were randomized. Six-month mean IOP values were similar to those at three months, when the mean IOP in patients treated with BBFC was significantly lower than that of either monotherapy group. A total of 175 patients experienced at least one treatment-related adverse event (BBFC, 33.0%; brinzolamide, 18.8%; brimonidine, 24.7%), eight of which were severe, and five resulted in discontinuation. Seventy-seven patients discontinued participation due to treatment-related adverse events (BBFC, 17.2%; brinzolamide, 2.1%; brimonidine, 14.5%). There were 21 serious adverse events (n = 7 in each group), none of which was related to treatment. Resting mean pulse and blood pressure with BBFC were similar to those with brimonidine, demonstrating modest, clinically insignificant decreases. No new or increased risks were identified with use of BBFC relative to either monotherapy. Conclusion: This study showed that, after six months of treatment, the safety profile of BBFC was similar to that of its individual components and its IOP-lowering activity was similar to its efficacy at three months, when it was superior to both brinzolamide 1% alone and brimonidine 0.2% alone. Keywords: brimonidine, brinzolamide, fixed combination, ocular hypertension, open-angle glaucoma
format	article
author	Whitson JT Realini T Nguyen QH McMenemy MG Goode SM
author_facet	Whitson JT Realini T Nguyen QH McMenemy MG Goode SM
author_sort	Whitson JT
title	Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension
title_short	Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension
title_full	Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension
title_fullStr	Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension
title_full_unstemmed	Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension
title_sort	six-month results from a phase iii randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension
publisher	Dove Medical Press
publishDate	2013
url	https://doaj.org/article/340614ab35254b5092eff1a93ff4728a
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Six-month results from a Phase III randomized trial of fixed-combination brinzolamide 1% + brimonidine 0.2% versus brinzolamide or brimonidine monotherapy in glaucoma or ocular hypertension

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