Document Detail

Safety and efficacy of bimatoprost 0.03% versus timolol maleate 0.5%/dorzolamide 2% fixed combination.
MedLine Citation:
PMID:  15945001     Owner:  NLM     Status:  MEDLINE    
PURPOSE: To determine the efficacy and safety of bimatoprost given every evening versus the dorzolamide/timolol fixed combination (DTFC) given twice daily in open-angle glaucoma and ocular hypertensive patients. METHODS: A double-masked, three-center, prospective, randomized, crossover comparison with two 8-week treatment periods following a 4-week medicine free washout period. Diurnal curve intraocular pressures (IOPs) were taken at 08:00 (trough) and 10:00 and 16:00 hours. RESULTS: A total of 35 patients were enrolled and 32 completed all evaluations. The diurnal untreated baseline intraocular pressures was 24.8 +/- 2.4 mmHg. On the last day of treatment the mean diurnal intraocular pressures was 17.4 +/- 2.9 for bimatoprost and 18.1 +/- 2.8 mmHg for DTFC (p = 0.35). The individual time points for intraocular pressures were not statistically different between groups. Both groups statistically reduced the intraocular pressures from baseline for each time point and for the diurnal curve (p < 0.05). Regarding ocular safety and tolerability, there was more conjunctival hyperemia with bimatoprost (n = 15) than with DTFC (n = 7, p = 0.013) and more burning and stinging with DTFC (n = 12) than with bimatoprost (n = 0, p = 0.0005). Few systemic adverse events were recorded and there was no statistical difference between groups for any individual event (p > 0.05). CONCLUSIONS: This study indicates that the intraocular pressures are lowered to a statistically similar amount with DTFC compared to bimatoprost in open-angle glaucoma and ocular hypertensive patients.
D G Day; E D Sharpe; C J Beischel; J N Jenkins; J A Stewart; W C Stewart
Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  European journal of ophthalmology     Volume:  15     ISSN:  1120-6721     ISO Abbreviation:  Eur J Ophthalmol     Publication Date:    2005 May-Jun
Date Detail:
Created Date:  2005-06-09     Completed Date:  2005-08-02     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9110772     Medline TA:  Eur J Ophthalmol     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  336-42     Citation Subset:  IM    
Omni Eye Services, Atlanta, GA, USA.
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MeSH Terms
Antihypertensive Agents / administration & dosage,  therapeutic use*
Circadian Rhythm
Cloprostenol / analogs & derivatives
Cross-Over Studies
Double-Blind Method
Drug Therapy, Combination
Follow-Up Studies
Glaucoma, Open-Angle / drug therapy*,  physiopathology
Intraocular Pressure / drug effects,  physiology
Lipids / administration & dosage,  therapeutic use*
Middle Aged
Ocular Hypertension / drug therapy,  physiopathology
Ophthalmic Solutions
Prospective Studies
Sulfonamides / administration & dosage,  therapeutic use*
Thiophenes / administration & dosage,  therapeutic use*
Timolol / administration & dosage,  therapeutic use*
Tonometry, Ocular
Treatment Outcome
Visual Acuity
Reg. No./Substance:
0/Amides; 0/Antihypertensive Agents; 0/Lipids; 0/Ophthalmic Solutions; 0/Sulfonamides; 0/Thiophenes; 0/bimatoprost; 130693-82-2/dorzolamide; 26839-75-8/Timolol; 40665-92-7/Cloprostenol

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

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