Document Detail


A 3-month randomized controlled trial of bimatoprost (LUMIGAN) versus combined timolol and dorzolamide (Cosopt) in patients with glaucoma or ocular hypertension.
MedLine Citation:
PMID:  14644719     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
PURPOSE: To compare the efficacy and safety of topical bimatoprost (LUMIGAN; Allergan, Inc., Irvine, CA) once daily with that of topical combined timolol and dorzolamide (Cosopt; Merck and Co, Inc., Whitehouse Station, NJ) twice daily. DESIGN: Prospective, randomized, double-masked, multicenter clinical trial. PARTICIPANTS: One hundred seventy-seven patients with a diagnosis of glaucoma or ocular hypertension and inadequate control of intraocular pressure (IOP) after at least 2 weeks of topical timolol maleate 0.5% monotherapy. METHODS: Patients were randomized to receive bimatoprost 0.03% once daily (n = 90) or combined timolol 0.5% and dorzolamide 2% twice daily (n = 87) over a 3-month period. MAIN OUTCOME MEASURES: Intraocular pressure, the primary end point, was measured at 8 AM and 10 AM at baseline, week 1, and months 1, 2, and 3, and also at 4 PM and 8 PM at baseline and month 3. RESULTS: Bimatoprost provided significantly greater IOP lowering compared with combined timolol and dorzolamide. At the 8 AM measurements, bimatoprost lowered mean IOP 6.8 mmHg to 7.6 mmHg from baseline, whereas combined timolol and dorzolamide lowered mean IOP 4.4 to 5.0 mmHg from baseline (P<0.001). At the last follow-up, patients had better diurnal IOP control with bimatoprost than combined timolol and dorzolamide. At 8 AM at the 3-month visit, the percentages of patients achieving IOPs of <or =13 mmHg, < or =14 mmHg, < or =15 mmHg, or < or =16 mmHg were more than twice as high for bimatoprost than for combined timolol and dorzolamide (all P< or =0.008). Taste perversion, ocular burning, and stinging with instillation were more common with combined timolol and dorzolamide, whereas conjunctival hyperemia was more common with bimatoprost. CONCLUSIONS: In individuals with glaucoma or ocular hypertension, uncontrolled on a topical beta-blocker alone, bimatoprost lowered IOP more consistently than did combined timolol and dorzolamide.
Authors:
Anne L Coleman; Fabian Lerner; Paula Bernstein; Scott M Whitcup
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Ophthalmology     Volume:  110     ISSN:  0161-6420     ISO Abbreviation:  Ophthalmology     Publication Date:  2003 Dec 
Date Detail:
Created Date:  2003-12-03     Completed Date:  2003-12-18     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  7802443     Medline TA:  Ophthalmology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  2362-8     Citation Subset:  IM    
Affiliation:
Jules Stein Eye Institute, UCLA, Los Angeles, California 90095, USA.
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MeSH Terms
Descriptor/Qualifier:
Administration, Topical
Adult
Aged
Aged, 80 and over
Amides
Antihypertensive Agents / administration & dosage*
Cloprostenol / analogs & derivatives
Double-Blind Method
Drug Combinations
Female
Glaucoma / drug therapy*
Humans
Intraocular Pressure / drug effects*
Lipids / administration & dosage*
Male
Middle Aged
Ocular Hypertension / drug therapy
Ophthalmic Solutions
Prospective Studies
Safety
Sulfonamides / administration & dosage*
Thiophenes / administration & dosage*
Timolol / administration & dosage*
Chemical
Reg. No./Substance:
0/Amides; 0/Antihypertensive Agents; 0/Drug Combinations; 0/Lipids; 0/Ophthalmic Solutions; 0/Sulfonamides; 0/Thiophenes; 0/bimatoprost; 0/dorzolamide-timolol combination; 26839-75-8/Timolol; 40665-92-7/Cloprostenol
Comments/Corrections
Comment In:
Ophthalmology. 2005 Feb;112(2):357-8; author reply 358-9   [PMID:  15691575 ]

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


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