pro-122 versus concomitant therapy in subjects with uncontrolled primary open-angle glaucoma (pro-122latam)

Conditions: Primary Open-angle Glaucoma

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

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.

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

Keywords: glaucoma primary open-angle glaucoma ophthalmic antihypertensives krytantek ofteno®. timolol brimonidine dorzolamide