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

  • STATUS
    Recruiting
  • days left to enroll
    46
  • participants needed
    51
  • sponsor
    Laboratorios Sophia S.A de C.V.
Updated on 2 January 2022
hypertension
ophthalmic solution
brimonidine tartrate ophthalmic solution
intraocular pressure
timolol
dorzolamide
brimonidine
pigmentary glaucoma
primary open angle glaucoma
concomitant therapy
brimonidine ophthalmic solution

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

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.

Details
Condition Primary Open-angle Glaucoma
Treatment PRO-122, Timolol eye drops, Dorzolamide-Timolol Ophthalmic, Brimonidine Ophthalmic Solution, Placebo1, Placebo 2, Krytantek
Clinical Study IdentifierNCT03193333
SponsorLaboratorios Sophia S.A de C.V.
Last Modified on2 January 2022

Eligibility

Yes No Not Sure

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
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