| Latanoprost 0.005% test formulation is as effective as Xalatan® in patients with ocular hypertension and primary open-angle glaucoma. | |
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MedLine Citation:
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PMID: 22167539 Owner: NLM Status: In-Data-Review |
Abstract/OtherAbstract:
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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. |
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Authors:
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Catherine Allaire; Alice Dietrich; Helmut Allmeier; Iveta Grundmane; Grazyna Mazur-Piotrowska; Pepo Neshev; Gunther Kahle |
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Publication Detail:
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Type: Journal Article |
Journal Detail:
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Title: European journal of ophthalmology Volume: 22 ISSN: 1724-6016 ISO Abbreviation: Eur J Ophthalmol Publication Date: 2012 Jan |
Date Detail:
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Created Date: 2011-12-14 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9110772 Medline TA: Eur J Ophthalmol Country: Italy |
Other Details:
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Languages: eng Pagination: 19-27 Citation Subset: IM |
Affiliation:
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European Pharmaceutical Clinical Sciences, Bausch & Lomb, Evry - France. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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