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

NCT03193333 | Terminated Phase 3 DMC

• 1 other identifier: SOPH122-0316/III
• Study Type: interventional
• Target: 51
• Locations: 2 countries
• Sites: 2

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

Conditions

Primary Open-angle Glaucoma

Keywords

glaucoma; primary open-angle glaucoma; Ophthalmic antihypertensives; Krytantek Ofteno®.; timolol; brimonidine; dorzolamide

Outcome Measures

Primary Outcomes (1)

• intraocular pressure (IOP)

  Intraocular pressure, Unit: Millimeters of mercury (mmHg) type of variable: Continuous, Measurement method: Goldman applanation tonometry. Normal intraocular pressure 11-21 mmHg

  90days

Study Arms (3)

PRO-122 group

EXPERIMENTAL

To validate the 3 flasks of the triple therapy will be used 1 bottle with the three active principles (PRO-122) and two placebos and thus comply with the masking. Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL. preservative free. Pharmaceutical form: Ophthalmic solution Made by: Laboratorios Sophia, S.A. de C.V. Posology: 1 drop every 12 hours for 90 days Description of the solution: clear, visibly particle free, slightly yellow solution, preservative free * Package description: 5 m multidose dropper bottle. * Placebo (for * Two pieces of approved placebo. Administered in 2 multidose dropper bottles. * Posology: 1 drop of each dropper bottle every 12 hours for 90 days

Drug: PRO-122; Other: Placebo1; Other: Placebo 2

Concomitant triple therapy group

ACTIVE COMPARATOR

Imot Ofteno Drug substance: Timolol 5 mg/mL Pharmaceutical form: Ophthalmic solution Made by Laboratorios Sophia S.A. de C.V. Alphagan Drug substance Brimonidine 2 mg/mL Pharmaceutical form: Ophthalmic solution Made by: Allergan, Inc. Trusopt Drug substance: Dorzolamide 20 mg/mL Pharmaceutical form: Ophthalmic solution Made by: Merck Sharp and Dohme Corp. Posology: 1 drop every 12 hours for 90 days

Drug: Timolol eye drops; Drug: Dorzolamide-Timolol Ophthalmic; Drug: Brimonidine Ophthalmic Solution

Krytantek Ofteno Group

ACTIVE COMPARATOR

To validate the three flasks of the triple therapy will be used 1 bottle with the three active principles (Krytantek) and two placebos and thus comply with the masking. Drug substances: Timolol 5 mg/mL, brimonidine 2 mg/mL and dorzolamide 20 mg/mL. Pharmaceutical form: Ophthalmic solution Made by: Laboratorios Sophia, S.A. de C.V. Posology: 1 drop every 12 hours for 90 days Description of the solution: clear, visibly particle free, slightly yellow solution Package description: 5 m multidose dropper bottle. Placebo (for two pieces of approved placebo. Administered in 2 multidose dropper bottles. Posology: 1 drop of each dropper bottle every 12 hours for 90 days

Other: Placebo1; Other: Placebo 2; Drug: Krytantek

Interventions

PRO-122 DRUG

Posology: 1 drop every 12 hours for 90 days

Also known as: krytantek PF (Timolol, Brimonidine, Dorzolamide)

PRO-122 group

Timolol eye drops DRUG

1 drop every 12 hours for 90 days

Also known as: Concomitant triple therapy

Concomitant triple therapy group

Dorzolamide-Timolol Ophthalmic DRUG

1 drop every 12 hours for 90 days

Also known as: Concomitant triple therapy

Concomitant triple therapy group

Brimonidine Ophthalmic Solution DRUG

1 drop every 12 hours for 90 days

Also known as: Concomitant triple therapy

Concomitant triple therapy group

Placebo1 OTHER

1 drop of each dropper bottle every 12 hours for 90 days

Krytantek Ofteno Group; PRO-122 group

Placebo 2 OTHER

1 drop of each dropper bottle every 12 hours for 90 days

Krytantek Ofteno Group; PRO-122 group

Krytantek DRUG

Posology: 1 drop every 12 hours for 90 days

Krytantek Ofteno Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age greater or equal to 18 years
• Both sexes
• Women of childbearing age with birth control method
• Diagnosis of Primary open-angle glaucoma (according to the Guidelines of the Preferred Practice Pattern of the American Academy of Ophthalmology) or ocular hypertension (OHT)
• Intraocular pressure (IOP) not controlled with dual therapy according to the principal investigator (PI) judgment.
• IOP on the selection visit at 9 am, after the washing period, from 21 - 36 mmHg in at least one eye.

You may not qualify if:

• General criteria
• Pregnant, breastfeeding or planning to get pregnant women.
• Women of childbearing age and who do not intake a hormonal contraceptive method, intrauterine device or bilateral tubal obstruction.
• Participation in another clinical research study greater or equal 30 days before the screening visit.
• People who cannot comply with their attendance at appointments or with all the - Protocol requirements
• Medical and therapeutic criteria:
• Anterior chamber angle grade less than 2 of Shaffer rating.
• Excavation of optic nerve greater than 0.80 horizontal or vertical (ratio cup-disc)
• Serious loss of central visual field in any eye (sensitivity less or equal to 10 decibels in greater or equal to 2 of 4 points of the visual field test close to the fixation point)
• People not able to safely suspend ocular hypotensives drug products for the washout period according to the PI judgement.
• Chronic, recurrent, or active ocular inflammatory diseases (e.g. uveitis, scleritis, keratitis, herpetic) in any eye.
• Eye trauma less or equal to 6 months prior to the study
• Eye infection / inflammation less or equal to 3 months prior to the study
• Clinically significant or progressive retinal disease (e.g. degenerations, diabetic retinopathy, retinal detachment)
• Ability Visual 20/200 or worse in any of the eyes.

Sponsors & Collaborators

• Laboratorios Sophia S.A de C.V.: lead

Study Sites (2)

MD. Sandra Belalcazar Rey

Bogotá, Bogota D.C., Colombia

Location

MD. Victoria Eugenia Sanchez Castellanos

Zapopan, Jalisco, 44960, Mexico

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Glaucoma

Interventions

Timolol; Brimonidine Tartrate; dorzolamide

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines; Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Leopoldo Baiza, MD

  Laboratorios Sophia S.A de C.V.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding will be performed by the personnel assigned by the Laboratorios Sophia S.A. de C.V. Clinical Operations Management. The blinding will consist in the elimination of the primary label (commercial) for Krytantek Ofteno® and the triple concomitant therapy and the placement of a label identical to those of the other interventions. Since the bottles in which Krytantek Ofteno® and the concomitant therapies are different in color and cap shape to the ones used for the placebo and the PRO-122, a masking will be performed in the primary packaging, which shall be identical for all three interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A non-inferiority, phase III, double-blind, randomized, controlled, parallel, clinical trial

Study Record Dates

• First Submitted: June 19, 2017
• First Posted: June 20, 2017
• Study Start: November 6, 2017
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1); CO (1)