NCT03193333

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

A Non-inferiority in the Intraocular Pressure Decrease of the Preservative-free Ophthalmic Solution PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Laboratorios Sophia S.A de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Primary Open-angle Glaucoma

Interventions

Type	Name	Description
DRUG	PRO-122	Posology: 1 drop every 12 hours for 90 days
DRUG	Timolol eye drops	1 drop every 12 hours for 90 days
DRUG	Dorzolamide-Timolol Ophthalmic	1 drop every 12 hours for 90 days
DRUG	Brimonidine Ophthalmic Solution	1 drop every 12 hours for 90 days
OTHER	Placebo1	1 drop of each dropper bottle every 12 hours for 90 days
OTHER	Placebo 2	1 drop of each dropper bottle every 12 hours for 90 days
DRUG	Krytantek	Posology: 1 drop every 12 hours for 90 days

Timeline

• Start date: 2017-11-06
• Primary completion: 2024-10-30
• Completion: 2024-10-30
• First posted: 2017-06-20
• Last updated: 2025-03-06

Locations

2 sites across 2 countries: Colombia, Mexico