PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)
Status:
Recruiting
Trial end date:
2021-09-30
Target enrollment:
Participant gender:
Summary
Objectives: To evaluate the non-inferiority in the intraocular pressure decrease of the
preservative-free ophthalmic solution PRO-122, manufactured by Laboratorios Sophia S.A. de
C.V., versus concomitant therapy in subjects with uncontrolled primary open-angle glaucoma
and/or IOP.
Hypothesis: The mean (average) value of the IOP final absolute reduction in the experimental
group (PRO-122) is not lower, considering a lower limit of 1 mmHg, compared to the IOP mean
absolute reduction of the standard group (concomitant therapy).
Methodology: A non-inferiority, phase III, double-blind, randomized, controlled, parallel,
clinical trial