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

NCT03193333 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2025-03-06

No results posted yet for this study

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

Conditions

  • Primary Open-angle Glaucoma

Interventions

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

Sponsors & Collaborators

  • Laboratorios Sophia S.A de C.V.

    lead INDUSTRY

Principal Investigators

  • Leopoldo Baiza, MD · Laboratorios Sophia S.A de C.V.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-06
Primary Completion
2024-10-30
Completion
2024-10-30

Countries

  • Colombia
  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03193333 on ClinicalTrials.gov