Document Detail


The safety and efficacy of brinzolamide 1%/timolol 0.5% fixed combination versus dorzolamide 2%/timolol 0.5% in patients with open-angle glaucoma or ocular hypertension.
MedLine Citation:
PMID:  19365194     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: This study compared the intraocular pressure (IOP)-lowering efficacy of 2 fixed combination products, brinzolamide 1%/timolol 0.5% suspension (Azarga, Brinz/Tim) and dorzolamide 2%/timolol 0.5% solution (Dorz/Tim), in patients with open-angle glaucoma or ocular hypertension who required a change in therapy due to elevated IOP while receiving IOP-lowering medication. METHODS: This was a one-year, multicenter, randomized, double-masked, active-controlled, parallel-group trial of Brinz/Tim and Dorz/Tim. IOP assessments were taken at 8 and 10 AM at week 2 and months 3 and 9, and at 8 AM, 10 AM, and 4 PM at months 6 and 12. Primary efficacy was a noninferiority comparison of mean IOP at the three month 6 time points. RESULTS: Of the 437 patients enrolled, 220 dosed Brinz/Tim whereas 217 dosed Dorz/Tim twice daily. Brinz/Tim produced IOP-lowering efficacy comparable to Dorz/Tim, with the upper 95% confidence limits for the differences between groups within +1.5 mm Hg at all assessment times, including the month 6 primary efficacy time points, establishing noninferiority. Differences in means numerically favored Brinz/Tim at 9 of 12 study visits and times. The IOP reductions ranged from 7.2 to 9.2 mm Hg for Brinz/Tim and from 7.4 to 8.9 mm Hg for Dorz/Tim. Although a similar overall safety profile was observed between the 2 treatment groups, Brinz/Tim showed significantly less ocular irritation (2.7% vs. 10.6%; P=0.0009) than Dorz/Tim. CONCLUSIONS: Brinz/Tim suspension provides statistically significant and clinically relevant IOP-lowering efficacy that is noninferior to Dorz/Tim. Additionally, Brinz/Tim affords an ocular comfort advantage compared with Dorz/Tim.
Authors:
Gianluca Manni; Phillipe Denis; Paul Chew; Elisabeth D Sharpe; Silvia Orengo-Nania; Michael A Coote; Guna Laganovska; Lasma Volksone; Thierry Zeyen; Isabella Filatori; John James; Tin Aung
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Journal of glaucoma     Volume:  18     ISSN:  1536-481X     ISO Abbreviation:  J. Glaucoma     Publication Date:    2009 Apr-May
Date Detail:
Created Date:  2009-04-14     Completed Date:  2009-07-01     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9300903     Medline TA:  J Glaucoma     Country:  United States    
Other Details:
Languages:  eng     Pagination:  293-300     Citation Subset:  IM    
Affiliation:
University of Rome, Tor Vergata, Bietti Foundation IRCSS, Rome, Italy. glmanni@inwind.it
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Adrenergic beta-Antagonists / adverse effects,  therapeutic use*
Adult
Aged
Aged, 80 and over
Carbonic Anhydrase Inhibitors / adverse effects,  therapeutic use*
Double-Blind Method
Drug Combinations
Female
Glaucoma, Open-Angle / drug therapy*
Humans
Intraocular Pressure / drug effects*
Male
Middle Aged
Ocular Hypertension / drug therapy
Prospective Studies
Sulfonamides / adverse effects,  therapeutic use*
Thiazines / adverse effects,  therapeutic use*
Thiophenes / adverse effects,  therapeutic use*
Timolol / adverse effects,  therapeutic use*
Tonometry, Ocular
Treatment Outcome
Young Adult
Chemical
Reg. No./Substance:
0/Adrenergic beta-Antagonists; 0/Carbonic Anhydrase Inhibitors; 0/Drug Combinations; 0/Sulfonamides; 0/Thiazines; 0/Thiophenes; 130693-82-2/dorzolamide; 138890-62-7/brinzolamide; 26839-75-8/Timolol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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