Comparison of clinical effects of two latanoprost 0.005% solutions (Xalatan® and Arulatan®) in primary open-angle glaucoma or ocular hypertensive patients: a randomized clinical trial

Rodrigo A Brant Fernandes,1 Luci Meire P Silva,1 Diego Torres Dias,1 Rafael Henrique Pereira,2 Rubens Belfort Jr,1,2 Tiago Santos Prata1–31Department of Ophthalmology and Visual Sciences, Federal University of São Paulo, São Paulo, SP, Brazil; 2IPEPO/Vision Institute – SP, São Paulo, SP, Brazil; 3Department of Ophthalmology, Mayo Clinic, Jacksonville, FL, USAPurpose: To evaluate the therapeutic non-inferiority between two ophthalmic latanoprost 0.005% solutions (Arulatan®, [ALT] versus the reference drug Xalatan®, [XLT]) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OH).Patients and methods: This was a 12-week Phase IV, experimental, randomized, parallel-group, double-masked clinical trial. Consecutive patients with POAG or OH from the Glaucoma Service of Instituto Paulista de Estudos e Pesquisas em Oftalmologia (São Paulo, Brazil) were enrolled between July and December 2017. The primary outcome of the study was an analysis of therapeutic non-inferiority between ALT versus XLT at 12 weeks, while secondary outcomes were mean intraocular pressure (IOP) change from baseline at 2, 6 and 12 weeks, mean IOP at 2, 6 and 12 weeks, and topical and systemic side effects. Statistical significance was set at P