PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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
Full 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
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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.
Enrollment
Sex
Ages
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
51 participants in 3 patient groups
Trial contacts and locations
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Central trial contact
Ricardo Llamas, PhD; Oscar Olvera, MD
Data sourced from clinicaltrials.gov
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