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Eur J Ophthalmol. 2012 Jan-Feb;22(1):19-27. doi: 10.5301/ejo.5000041.

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

Author information

1
European Pharmaceutical Clinical Sciences, Bausch & Lomb, Evry, France. catherine.allaire@bausch.com

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.

PMID:
22167539
DOI:
10.5301/ejo.5000041
[Indexed for MEDLINE]

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