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

Primary Purpose

Primary Open-angle Glaucoma

Status

Recruiting

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PRO-122

Timolol eye drops

Dorzolamide-Timolol Ophthalmic

Brimonidine Ophthalmic Solution

Placebo1

Placebo 2

Krytantek

About this trial

This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring glaucoma, primary open-angle glaucoma, Ophthalmic antihypertensives, Krytantek Ofteno®., timolol, brimonidine, dorzolamide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Subject with only one eye
Eye diseases that contraindicate the use of Beta-blocker (BB) Alpha-adrenergic agonist (AA) or Carbonic anhydrase inhibitors (CAIs)
Intraocular surgery less or equal to 6 months prior to the study
Laser intraocular surgery less or equal to 3 months prior to the study
Any abnormality preventing reliable applanation tonometry
Unstable or uncontrolled cardiovascular disease
Chronic pulmonary disease (e.g. bronchial asthma)
Any condition or illness that do not fit the subject for the study according to the PI judgment.
Use of high doses of salicylate (1 g daily) less or equal to4 weeks before the eligibility visit
In treatment with psychotropic medications that increase the adrenergic response
Known hypersensitivity to BB medications (e.g. timolol), AA (e.g. brimonidine) and CAI (e.g. dorzolamide), sulfonamide derivatives, or any of the components of the study drugs
Concomitant use of monoamine oxidase inhibitors
Systemic or topical use of corticosteroids

Sites / Locations

MD. Sandra Belalcazar ReyRecruiting
MD. Victoria Eugenia Sanchez CastellanosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

PRO-122 group

Concomitant triple therapy group

Krytantek Ofteno Group

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03193333

First Posted

June 19, 2017

Last Updated

December 27, 2022

Sponsor

Laboratorios Sophia S.A de C.V.

1. Study Identification

Unique Protocol Identification Number

NCT03193333

Brief Title

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

Acronym

PRO-122LATAM

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 6, 2017 (Actual)

Primary Completion Date

June 30, 2023 (Anticipated)

Study Completion Date

June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Laboratorios Sophia S.A de C.V.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Primary Open-angle Glaucoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

51 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRO-122 group

Arm Type

Experimental

Arm Description

Arm Title

Concomitant triple therapy group

Arm Type

Active Comparator

Arm Description

Arm Title

Krytantek Ofteno Group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

PRO-122

Other Intervention Name(s)

krytantek PF (Timolol, Brimonidine, Dorzolamide)

Intervention Description

Posology: 1 drop every 12 hours for 90 days

Intervention Type

Drug

Intervention Name(s)

Timolol eye drops

Other Intervention Name(s)

Concomitant triple therapy

Intervention Description

1 drop every 12 hours for 90 days

Intervention Type

Drug

Intervention Name(s)

Dorzolamide-Timolol Ophthalmic

Other Intervention Name(s)

Concomitant triple therapy

Intervention Description

1 drop every 12 hours for 90 days

Intervention Type

Drug

Intervention Name(s)

Brimonidine Ophthalmic Solution

Other Intervention Name(s)

Concomitant triple therapy

Intervention Description

1 drop every 12 hours for 90 days

Intervention Type

Other

Intervention Name(s)

Placebo1

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Placebo 2

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Krytantek

Intervention Description

Posology: 1 drop every 12 hours for 90 days

Primary Outcome Measure Information:

Title

intraocular pressure (IOP)

Description

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

Time Frame

90days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Subject with only one eye Eye diseases that contraindicate the use of Beta-blocker (BB) Alpha-adrenergic agonist (AA) or Carbonic anhydrase inhibitors (CAIs) Intraocular surgery less or equal to 6 months prior to the study Laser intraocular surgery less or equal to 3 months prior to the study Any abnormality preventing reliable applanation tonometry Unstable or uncontrolled cardiovascular disease Chronic pulmonary disease (e.g. bronchial asthma) Any condition or illness that do not fit the subject for the study according to the PI judgment. Use of high doses of salicylate (1 g daily) less or equal to4 weeks before the eligibility visit In treatment with psychotropic medications that increase the adrenergic response Known hypersensitivity to BB medications (e.g. timolol), AA (e.g. brimonidine) and CAI (e.g. dorzolamide), sulfonamide derivatives, or any of the components of the study drugs Concomitant use of monoamine oxidase inhibitors Systemic or topical use of corticosteroids

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ricardo Llamas, PhD

Phone

(33)30014200

Ext

1259

ricardo.llamas@sophia.com.mx

First Name & Middle Initial & Last Name or Official Title & Degree

Oscar Olvera, MD

Phone

(33)30014200

Ext

1074

oscar.olvera@sophia.com.mx

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Leopoldo Baiza, MD

Organizational Affiliation

Laboratorios Sophia S.A de C.V.

Official's Role

Study Director

Facility Information:

Facility Name

MD. Sandra Belalcazar Rey

City

Bogotá

State/Province

Bogotá D.C.

Country

Colombia

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mariana Cabrera, MD

Phone

+5713487333

Ext

1605

First Name & Middle Initial & Last Name & Degree

Claudia Carbajal, BD

Phone

+5713487333

Ext

1605

Facility Name

MD. Victoria Eugenia Sanchez Castellanos

City

Zapopan

State/Province

Jalisco

ZIP/Postal Code

44960

Country

Mexico

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Victoria Sanchez Castellanos, MD

Phone

+5213339152222

victoriaoftalmo@hotmail.com

First Name & Middle Initial & Last Name & Degree

Miguel Montes Salcedo, MD

Phone

+5213339152222

doctorlasik@yahoo.com.mx

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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