PRO-122 Versus Concomitant Therapy in Subjects With Uncontrolled Primary Open-angle Glaucoma (PRO-122LATAM) (PRO-122LATAM)
Primary Open-angle Glaucoma
About this trial
This is an interventional treatment trial for Primary Open-angle Glaucoma focused on measuring glaucoma, primary open-angle glaucoma, Ophthalmic antihypertensives, Krytantek Ofteno®., timolol, brimonidine, dorzolamide
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
Sites / Locations
- MD. Sandra Belalcazar ReyRecruiting
- MD. Victoria Eugenia Sanchez CastellanosRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Active Comparator
Active Comparator
PRO-122 group
Concomitant triple therapy group
Krytantek Ofteno 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
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
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