Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-25 @ 2:49 AM
NCT ID:
NCT03193333
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03193333
Study Brief:
Protocol Section:
NCT03193333