drugset / Trial / NCT02047630

Efficacy of the Brand-name Latanoprost and One of Its Generic Version in Primary Open Angle Glaucoma and Ocular Hypertension

NCT02047630

Phase 4 Terminated 60 enrolled CHU de Quebec-Universite Laval
RandomizedCrossoverQuadruple-blindTreatment

Summary

The purpose of this study is to evaluate and compare efficacy and tolerability of the brand-name latanoprost and one of its generic version in subjects with primary open angle glaucoma or ocular hypertension. This randomized, double-blinded, cross-over design study has a 4 months follow-up. There are two periods of 8 weeks. During the first period, subjects put brand-name latanoprost in one eye and the generic version in the other one. In the second period, drops are switched from one eye to the other. There are intraocular pressure measurements (diurnal curves) on day 0 (before treatment), at 8 weeks (at the end of first period) and at 16 weeks (at the end of second period). Variations of intraocular pressure in each eye will be evaluated.

Timeline

Start
2014-01
Primary completion
2014-12-04
Completion
2014-12-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Latanoprost Small molecule Other