Document Detail


Latanoprost 0.005% test formulation is as effective as Xalatan® in patients with ocular hypertension and primary open-angle glaucoma.
MedLine Citation:
PMID:  22167539     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Purpose. To determine if a test formulation of latanoprost 0.005% (Bausch & Lomb) eyedrops reduced intraocular pressure (IOP) as well as Xalatan® (latanoprost 0.005%) in patients with ocular hypertension (OH) or primary open-angle glaucoma (POAG). Methods. This multicenter, randomized, investigator-masked, parallel-group study allocated 266 patients with OH or POAG in a 1:1 ratio to latanoprost or Xalatan administered once daily for 6 weeks. The primary endpoint was the mean change in 8:00 am IOP of the study eye from baseline to week 6. Secondary endpoints included mean change in 8:00 am IOP from baseline to week 2, and in 12:00 noon and 4:00 pm IOP from baseline to week 2 and week 6. The safety and tolerability of both drugs were also assessed. Results. Both study groups had comparable demographics and baseline characteristics. The mean (SD) change in 8:00 am IOP from baseline to week 6 was -7.29 (2.61) and -7.54 (2.80) mmHg with latanoprost and Xalatan, respectively. Latanoprost was found noninferior to Xalatan in the primary analysis (mean [SEM] treatment difference, 0.252 [0.504] mmHg; 95% confidence interval [CI] -0.408, 0.913; p = 0.0001; noninferiority margin, 1.5 mmHg) and met the predefined definition of equivalence to Xalatan (95% CI within [-1.5, 1.5 mmHg] margin). The IOP-lowering effects of latanoprost and Xalatan were comparable at all assessed time points. Both study treatments demonstrated a comparable safety and tolerability profile. Conclusions. Bausch & Lomb latanoprost 0.005% is clinically equivalent to Xalatan for treating OH and POAG as demonstrated through this unique comparative trial.
Authors:
Catherine Allaire; Alice Dietrich; Helmut Allmeier; Iveta Grundmane; Grazyna Mazur-Piotrowska; Pepo Neshev; Gunther Kahle
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  European journal of ophthalmology     Volume:  22     ISSN:  1724-6016     ISO Abbreviation:  Eur J Ophthalmol     Publication Date:  2012 Jan 
Date Detail:
Created Date:  2011-12-14     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9110772     Medline TA:  Eur J Ophthalmol     Country:  Italy    
Other Details:
Languages:  eng     Pagination:  19-27     Citation Subset:  IM    
Affiliation:
European Pharmaceutical Clinical Sciences, Bausch & Lomb, Evry - France.
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