PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)

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

Timeline

Start

2017-11-06

Primary completion

2024-10-30

Completion

2024-10-30

Publications

• Belalcazar S, Tornero-Jimenez A, Mejia-Morales C, Olvera-Montano O, Munoz-Villegas P. Assessment of the Effectiveness, Tolerability, and Safety of the Preservative-Free Fixed Combination of Timolol, Dorzolamide, and Brimonidine Compared to Separate Therapies in Patients with Glaucoma, a Randomized Controlled Trial. Clin Ophthalmol. 2026 Feb 19;20:580973. doi: 10.2147/OPTH.S580973. eCollection 2026.

Drugs

Indications