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

Number of patients: 51 subjects divided into 3 groups (17 subjects per group) Diagnosis and main inclusion criterion: Diagnosis: Primary open-angle glaucoma or ocular hypertension Main criteria: - Patients of either sex - Average intraocular pressure (IOP) ≤ 36 mm/Hg - Previous management with ocular hypotensive medications ≥ 2 months, without achieving control (target IOP) - Age ≥ 18 years - Informed consent Test product, dosage and route of administration: - PRO-122. Preservative-free ophthalmic solution of timolol 0.5% / brimonidine 0.2% / dorzolamide 2% Manufactured by Laboratorios Sophia, S.A. de C.V., Zapopan, Jalisco, Mexico. + Placebo + Placebo - Dosage: 1 drop every 12 hours - Route of administration: ophthalmic Treatment duration: 90 days Evaluation criteria: Efficiency (non-inferiority): - IOP decrease Safety: - Best corrected visual acuity - Cup-to-disc ratio - Visual fields determined by computerized perimetry - Central corneal thickness determined by pachymetry - Ocular surface integrity, including: - Conjunctival hyperemia - Chemosis - Fluorescein staining - Density of goblet cells - Adverse events Tolerability: - Ocular comfort index Statistical methodology: The data will be expressed with measures of central tendency: mean and standard deviation for quantitative variables. The qualitative variables will be presented in frequencies and percentages. Statistical analysis will be done by means of a Kruskal-Wallis test for quantitative variables. The difference between qualitative variables will be analyzed using an square chi An alpha ≤ 0.05 would be considered as significant.