PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)
NCT ID: NCT03193333
Last Updated: 2025-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
51 participants
INTERVENTIONAL
2017-11-06
2024-10-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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PRO-122 group
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
PRO-122
Posology: 1 drop every 12 hours for 90 days
Placebo1
1 drop of each dropper bottle every 12 hours for 90 days
Placebo 2
1 drop of each dropper bottle every 12 hours for 90 days
Concomitant triple therapy group
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
Timolol eye drops
1 drop every 12 hours for 90 days
Dorzolamide-Timolol Ophthalmic
1 drop every 12 hours for 90 days
Brimonidine Ophthalmic Solution
1 drop every 12 hours for 90 days
Krytantek Ofteno Group
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
Placebo1
1 drop of each dropper bottle every 12 hours for 90 days
Placebo 2
1 drop of each dropper bottle every 12 hours for 90 days
Krytantek
Posology: 1 drop every 12 hours for 90 days
Interventions
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PRO-122
Posology: 1 drop every 12 hours for 90 days
Timolol eye drops
1 drop every 12 hours for 90 days
Dorzolamide-Timolol Ophthalmic
1 drop every 12 hours for 90 days
Brimonidine Ophthalmic Solution
1 drop every 12 hours for 90 days
Placebo1
1 drop of each dropper bottle every 12 hours for 90 days
Placebo 2
1 drop of each dropper bottle every 12 hours for 90 days
Krytantek
Posology: 1 drop every 12 hours for 90 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Laboratorios Sophia S.A de C.V.
INDUSTRY
Responsible Party
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Principal Investigators
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Leopoldo Baiza, MD
Role: STUDY_DIRECTOR
Laboratorios Sophia S.A de C.V.
Locations
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MD. Sandra Belalcazar Rey
Bogotá, Bogota D.C., Colombia
MD. Victoria Eugenia Sanchez Castellanos
Zapopan, Jalisco, Mexico
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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SOPH122-0316/III
Identifier Type: -
Identifier Source: org_study_id
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