1. Latanoprost 0.005% test formulation is as effective as Xalatan® in patients with ocular hypertension and primary open-angle glaucoma.
- Author
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Allaire C, Dietrich A, Allmeier H, Grundmane I, Mazur-Piotrowska G, Neshev P, and Kahle G
- Subjects
- Antihypertensive Agents adverse effects, Blood Pressure, Female, Heart Rate, Humans, Latanoprost, Male, Middle Aged, Ocular Hypertension drug therapy, Ophthalmic Solutions, Prospective Studies, Prostaglandins F, Synthetic adverse effects, Therapeutic Equivalency, Tonometry, Ocular, Treatment Outcome, Antihypertensive Agents administration & dosage, Glaucoma, Open-Angle drug therapy, Intraocular Pressure drug effects, Prostaglandins F, Synthetic administration & dosage
- 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.
- Published
- 2012
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