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

Primary Open-angle Glaucoma Clinical Trial

Official title: 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 Recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

• NCT number: NCT03193333
• Study type: Interventional
• Source: Laboratorios Sophia S.A de C.V.
• Contact: Ricardo Llamas, PhD
• Phone: (33)30014200
• Email: ricardo.llamas@sophia.com.mx
• Status: Recruiting
• Phase: Phase 3
• Start date: November 6, 2017
• Completion date: June 30, 2024