NCT02047630

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Primary Open Angle Glaucoma
• Ocular Hypertension

Interventions

Type	Name	Description
DRUG	Generic latanoprost
DRUG	Brand-name latanoprost

Timeline

• Start date: 2014-01-01
• Primary completion: 2014-12-04
• Completion: 2014-12-04
• First posted: 2014-01-28
• Last updated: 2017-07-25

Locations

1 site across 1 country: Canada