Latanoprost 0.005% test formulation is as effective as Xalatan® in patients with ocular hypertension and primary open-angle glaucoma

Eur J Ophthalmol 2012; 22(1): 19 - 27

Article Type: ORIGINAL ARTICLE

DOI:10.5301/ejo.5000041

Authors

Catherine Allaire, Alice Dietrich, Helmut Allmeier, Iveta Grundmane, Grazyna Mazur-Piotrowska, Pepo Neshev, Gunther Kahle

Abstract

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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