Document Detail


Timolol 0.5%/dorzolamide 2% fixed combination vs timolol maleate 0.5% and unoprostone 0.15% given twice daily to patients with primary open-angle glaucoma or ocular hypertension.
MedLine Citation:
PMID:  12566015     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To compare the efficacy and safety of timolol 0.5%/dorzolamide 2% fixed combination vs timolol maleate 0.5% and unoprostone 0.15% given twice daily. DESIGN: Prospective multicenter, randomized, double-masked, crossover comparison study. METHODS: Primary open-angle glaucoma or ocular hypertension patients were randomly assigned to one of the treatment groups for a 6-week treatment period and then crossed over to the opposite treatment. Diurnal curve testing was performed at 8:00 AM, 10:00 AM, 4:00 PM, 6:00 PM, and 8:00 PM at baseline and the end of each treatment period. The run-in medicine was timolol twice daily for 28 days. RESULTS: Thirty-two patients completed this trial. The baseline trough pressure was 24.3 +/- 3.0 mm Hg, and the diurnal curve was 23.4 +/- 3.2 mm Hg. For the fixed combination the treatment trough pressure was 20.8 +/- 4.1 mm Hg and the diurnal curve was 19.6 +/- 3.6 mm Hg, whereas timolol and unoprostone concomitant therapy showed a treatment trough pressure of 20.1 +/- 4.5 mm Hg and a diurnal pressure of 19.8 +/- 4.1 mm Hg. There was no significant difference between treatment groups at any time point, for the diurnal curve, or in the extended reduction from baseline. There was no difference between treatment groups regarding ocular and systemic unsolicited or solicited adverse events. Burning, stinging, and conjunctival hyperemia were the adverse events most noted. There were no serious adverse events during this trial. CONCLUSIONS: This study suggests that both timolol/dorzolamide 2% fixed combination and concomitant timolol maleate 0.5% and unoprostone 0.15% therapy provide similar efficacy and safety throughout the daytime diurnal curve.
Authors:
Douglas G Day; Paul N Schacknow; Martin Wand; Elizabeth D Sharpe; Jeanette A Stewart; Jessica Leech; William C Stewart
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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:  American journal of ophthalmology     Volume:  135     ISSN:  0002-9394     ISO Abbreviation:  Am. J. Ophthalmol.     Publication Date:  2003 Feb 
Date Detail:
Created Date:  2003-02-04     Completed Date:  2003-02-13     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0370500     Medline TA:  Am J Ophthalmol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  138-43     Citation Subset:  AIM; IM    
Affiliation:
Omni Eye Services, LLC, Atlanta, Georgia, USA.
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MeSH Terms
Descriptor/Qualifier:
Antihypertensive Agents / administration & dosage,  adverse effects,  therapeutic use*
Cross-Over Studies
Dinoprost / adverse effects,  analogs & derivatives*,  therapeutic use*
Drug Therapy, Combination
Female
Glaucoma, Open-Angle / drug therapy*
Humans
Intraocular Pressure / drug effects
Male
Middle Aged
Ocular Hypertension / drug therapy*
Ophthalmic Solutions
Prospective Studies
Safety
Sulfonamides / administration & dosage,  adverse effects,  therapeutic use*
Thiophenes / administration & dosage,  adverse effects,  therapeutic use*
Timolol / administration & dosage,  adverse effects,  therapeutic use*
Treatment Outcome
Visual Acuity
Chemical
Reg. No./Substance:
0/Antihypertensive Agents; 0/Ophthalmic Solutions; 0/Sulfonamides; 0/Thiophenes; 130693-82-2/dorzolamide; 26839-75-8/Timolol; 551-11-1/Dinoprost; 69553-75-9/isopropyl unoprostone

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


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