Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT03193333
Brief 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.
Study:
NCT03193333
Study Brief:
Protocol Section:
NCT03193333