[Clinical trial of the generic product UNILAT following its efficiency and safety in glaucoma and intraocular hypertension]. / Klinické sledovanie ucinnosti a bezpecnosti generického produktu UNILAT v terapii glaukómu a vnútroocnej hypertenzie.

ABSTRACT

The authors introduce UNILAT, a new generic product from UNIMED PHARMA Ltd., a Slovak pharmaceutical company. Within the Phase III. of clinical trial they evaluate UNILATes efficacy and safety in the treatment of glaucoma and intraocular hypertension. The clinical study design was performed as an open comparative multicenter trial. Its goal was to compare the UNILAT generic product (latanoprost 50 microg/ml, eye drops solution, Unimed Pharma) with XALATAN original product (latanoprost 50 microg/ml, eye drops solution, Pfizer) and to prove that UNILAT is as effective and safe as original product. The study was performed on 77 subjects in seven private ophthalmic outpatient departments in Slovakia during the period from February 5, 2008 till July 24, 2008. The primary endpoint specified to prove UNILAT's efficacy was the average decrease of IOP measured between the first and last visit. The secondary endpoint was proportion of patients with measured IOP less than 21 mmHg at the end of the clinical trial. The safety of the generic product was based on the frequency of adverse reactions in subjects included in the study. Results of clinical study have confirmed UNILAT's therapeutical indications and demonstrated that it is non-inferior to the original product concerning efficacy and safety in the treatment of glaucoma and ocular hypertension.