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

• Status: Recruiting
• Trial end date: 2021-09-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratorios Sophia S.A de C.V.
• Treatments: Brimonidine Tartrate; Dorzolamide; Ophthalmic Solutions; Pharmaceutical Solutions; Timolol

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