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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Centre universitaire d'ophtalmologie, Hôpital du Saint-Sacrement, CHU de Québec
Québec, Canada
Change in Intraocular Pressure (IOP)
Goldman applanation tonometry will be used to measure IOP.
Time frame: 8 weeks, 16 weeks
Change in Conjunctival hyperemia
Time frame: 8 weeks, 16 weeks
Change in corneal staining
Oxford grading scale
Time frame: 8 weeks, 16 weeks
Change in TSS-IOP (Treatment Satisfaction Survey for IntraOcular Pressure)
Time frame: 8 weeks, 16 weeks
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