A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost

E Randy Craven1, Ching-Chi Liu2, Amy Batoosingh2, Rhett M Schiffman2, Scott M Whitcup21Glaucoma Consultants of Colorado, Denver, CO, USA; 2Allergan, Inc., Irvine, CA, USA; This work was presented in part at the 19th Annual Meeting of the American Glaucoma Society (AGS); March 5&ndash;8, 2009...

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Autores principales:	E Randy Craven, Ching-Chi Liu, Amy Batoosingh, et al
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2010
Materias:	Ophthalmology RE1-994
Acceso en línea:	https://doaj.org/article/9968df5e7f784278906437be3f5ab65b
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spelling	oai:doaj.org-article:9968df5e7f784278906437be3f5ab65b2021-12-02T06:28:22ZA randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost1177-54671177-5483https://doaj.org/article/9968df5e7f784278906437be3f5ab65b2010-12-01T00:00:00Zhttp://www.dovepress.com/a-randomized-controlled-comparison-of-macroscopic-conjunctival-hyperem-a5829https://doaj.org/toc/1177-5467https://doaj.org/toc/1177-5483E Randy Craven1, Ching-Chi Liu2, Amy Batoosingh2, Rhett M Schiffman2, Scott M Whitcup21Glaucoma Consultants of Colorado, Denver, CO, USA; 2Allergan, Inc., Irvine, CA, USA; This work was presented in part at the 19th Annual Meeting of the American Glaucoma Society (AGS); March 5&ndash;8, 2009; San Diego, CA, USAPurpose: To evaluate conjunctival hyperemia associated with bimatoprost 0.01% treatment in patients who replace latanoprost 0.005% with bimatoprost 0.01%.Methods: Randomized, double-masked, vehicle-controlled, multicenter study of patients with ocular hypertension or glaucoma whose intraocular pressure (IOP) was adequately controlled on latanoprost monotherapy. At baseline, patients discontinued latanoprost and were randomized to treatment with once-daily bimatoprost 0.01% (n = 151) or vehicle (n = 71). The primary endpoint was the peak change in macroscopic hyperemia (conjunctival hyperemia evaluated by gross visual inspection) from baseline to month 1.Results: Bimatoprost 0.01% was noninferior to vehicle in the mean [standard deviation] peak change from baseline macroscopic hyperemia at month 1 (0.18 [0.46] in the bimatoprost 0.01% group vs 0.02 [0.32] in the vehicle group, P = 0.009). The between-group difference was 0.15 (95% confidence interval [CI]: 0.04, 0.26), which was within the predefined margin for noninferiority of 0.5 on a hyperemia grading scale of 0 to +3. There were no statistically significant between-group differences in the percentage of patients with a &ge;1-grade increase in macroscopic hyperemia from baseline. Mean IOP was decreased from baseline (-0.7 to -1.3 mm Hg) in the bimatoprost 0.01% group (P &le; 0.002) and was increased from baseline (+3.3 to +3.6 mm Hg) in the vehicle group (P &lt; 0.001) at month 1. There were no statistically significant between-group differences in adverse events.Conclusions: Bimatoprost 0.01% was noninferior to vehicle with respect to conjunctival hyperemia in this study population. Replacement of latanoprost with bimatoprost 0.01% in patients with ocular hypertension or glaucoma can result in additional IOP reduction without clinically important hyperemia.Keywords: conjunctiva, glaucoma, hyperemia, intraocular pressure, prostaglandin analogs, topical drug administration E Randy CravenChing-Chi LiuAmy Batoosinghet alDove Medical PressarticleOphthalmologyRE1-994ENClinical Ophthalmology, Vol 2010, Iss default, Pp 1433-1440 (2010)
institution	DOAJ
collection	DOAJ
language	EN
topic	Ophthalmology RE1-994
spellingShingle	Ophthalmology RE1-994 E Randy Craven Ching-Chi Liu Amy Batoosingh et al A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost
description	E Randy Craven1, Ching-Chi Liu2, Amy Batoosingh2, Rhett M Schiffman2, Scott M Whitcup21Glaucoma Consultants of Colorado, Denver, CO, USA; 2Allergan, Inc., Irvine, CA, USA; This work was presented in part at the 19th Annual Meeting of the American Glaucoma Society (AGS); March 5&ndash;8, 2009; San Diego, CA, USAPurpose: To evaluate conjunctival hyperemia associated with bimatoprost 0.01% treatment in patients who replace latanoprost 0.005% with bimatoprost 0.01%.Methods: Randomized, double-masked, vehicle-controlled, multicenter study of patients with ocular hypertension or glaucoma whose intraocular pressure (IOP) was adequately controlled on latanoprost monotherapy. At baseline, patients discontinued latanoprost and were randomized to treatment with once-daily bimatoprost 0.01% (n = 151) or vehicle (n = 71). The primary endpoint was the peak change in macroscopic hyperemia (conjunctival hyperemia evaluated by gross visual inspection) from baseline to month 1.Results: Bimatoprost 0.01% was noninferior to vehicle in the mean [standard deviation] peak change from baseline macroscopic hyperemia at month 1 (0.18 [0.46] in the bimatoprost 0.01% group vs 0.02 [0.32] in the vehicle group, P = 0.009). The between-group difference was 0.15 (95% confidence interval [CI]: 0.04, 0.26), which was within the predefined margin for noninferiority of 0.5 on a hyperemia grading scale of 0 to +3. There were no statistically significant between-group differences in the percentage of patients with a &ge;1-grade increase in macroscopic hyperemia from baseline. Mean IOP was decreased from baseline (-0.7 to -1.3 mm Hg) in the bimatoprost 0.01% group (P &le; 0.002) and was increased from baseline (+3.3 to +3.6 mm Hg) in the vehicle group (P &lt; 0.001) at month 1. There were no statistically significant between-group differences in adverse events.Conclusions: Bimatoprost 0.01% was noninferior to vehicle with respect to conjunctival hyperemia in this study population. Replacement of latanoprost with bimatoprost 0.01% in patients with ocular hypertension or glaucoma can result in additional IOP reduction without clinically important hyperemia.Keywords: conjunctiva, glaucoma, hyperemia, intraocular pressure, prostaglandin analogs, topical drug administration
format	article
author	E Randy Craven Ching-Chi Liu Amy Batoosingh et al
author_facet	E Randy Craven Ching-Chi Liu Amy Batoosingh et al
author_sort	E Randy Craven
title	A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost
title_short	A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost
title_full	A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost
title_fullStr	A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost
title_full_unstemmed	A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost
title_sort	randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost
publisher	Dove Medical Press
publishDate	2010
url	https://doaj.org/article/9968df5e7f784278906437be3f5ab65b
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A randomized, controlled comparison of macroscopic conjunctival hyperemia in patients treated with bimatoprost 0.01% or vehicle who were previously controlled on latanoprost

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