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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
Sponsored by
Laboratorios Sophia S.A de C.V.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

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

First Posted
June 19, 2017
Last Updated
December 27, 2022
Sponsor
Laboratorios Sophia S.A de C.V.
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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
No
Studies a U.S. FDA-regulated Device Product
No
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
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
Arm Title
Concomitant triple therapy group
Arm Type
Active Comparator
Arm Description
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
Arm Title
Krytantek Ofteno Group
Arm Type
Active Comparator
Arm Description
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
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
No
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
Email
ricardo.llamas@sophia.com.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Oscar Olvera, MD
Phone
(33)30014200
Ext
1074
Email
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
Email
victoriaoftalmo@hotmail.com
First Name & Middle Initial & Last Name & Degree
Miguel Montes Salcedo, MD
Phone
+5213339152222
Email
doctorlasik@yahoo.com.mx

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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