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    
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.
Catherine Allaire; Alice Dietrich; Helmut Allmeier; Iveta Grundmane; Grazyna Mazur-Piotrowska; Pepo Neshev; Gunther Kahle
Related Documents :
22215369 - Risk factors and distribution of symptomatic venous thromboembolism in total hip and kn...
22110909 - Assessment of procalcitonin to predict outcome in hypothermia-treated patients after ca...
21852579 - Minocycline-edta lock solution prevents catheter-related bacteremia in hemodialysis.
25360429 - Effectiveness of sodium picosulfate/magnesium citrate (pico) for colonoscopy preparation.
20148979 - Radioisotope synoviorthesis with holmium-166-chitosan complex in haemophilic arthropathy.
25179189 - Persistence in treatment for one year among patients in nigeria with first-episode schi...
14697909 - Patient persistency with topical ocular hypotensive therapy in a managed care population.
25369009 - Congenital hypothyroidism: etiology and growth-development outcome.
24378629 - A prospective randomized controlled study on the treatment outcome of spinecor brace ve...
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    
European Pharmaceutical Clinical Sciences, Bausch & Lomb, Evry - France.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms

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

Previous Document:  Efficacy and tolerability of prostaglandin-timolol fixed combinations: a meta-analysis of randomized...
Next Document:  Timogel® vs timolol 0.5% ophthalmic solution: efficacy, safety, and acceptance.