Primary open-angle glaucoma
Conditions
Interventions
The study population will consist of 260 participants aged 18 years-old or over, diagnosed with primary open-angle glaucoma or ocular hypertension.
Efficacy and safety will be assessed in both groups:
Drug
N06.850.135.060.075
Sponsors
Laboratório Daudt Oliveira Ltda.
Centro de Pesquisa Clínica São Lucas
Synova Pesquisa Científica Ltda.
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Men or women aged 18 years-old or over; having a diagnosis of primary open-angle glaucoma or ocular hypertension; being able to sign the ICF approved by IRB and to execute and understand all study procedures and instructions; having intraocular pressure greater than or equal to 21 and less than or equal to 30 mmHg in, at least, one eye; having an optical disc excavation of 0,8 or less
Exclusion criteria
Exclusion criteria: Presenting blindness in one eye; having visual acuity worse than or equal to 20/40 in either eye without justified cause; presenting a history of any concomitant active-stage eye disease, except those specified in inclusion criteria; for participants taking medication to treat primary open-angle glaucoma or ocular hypertension may only participate in the study if they discontinue the drug for a period of up to 7 (± 2) to 30 (± 2) days, according to the therapeutic class of the medication used; making use of topical corticosteroids ophtalmic or topical within 14 days from the screening visit. It is prohibited the use of systemic corticosteroids and psychotropic medicines with adrenergic potential (eg desipramine, amitriptyline) within 1 month of the screening visit or any other medication which, regardless of the route of administration, interfere with the study results and offer a risk to the participant's safety, at the investigator's discretion, used within 48 hours prior to the screening visit or until residual effects may be present; having an allergy to sulfa drugs; having hypersensitivity to the active ingredients and excipients of the study medications; wearing contact lenses 7 days before the screening visit (pre-treatment) and throughout the study; current history of bronchial asthma or chronic obstructive pulmonary disease (COPD), sinus bradycardia, 2nd or 3rd degree heart block, heart failure, cardiogenic shock; current or previous history of severe renal or hepatic impairment, current history of diabetic retinopathy or any other clinical condition that, at the investigator's discretion, contraindicates participation in the study or interferes with the study outcome; participants of childbearing age who do not agree to use a adequate form of contraception; pregnant, nursing women who plan to become pregnant, or who have a positive pregnancy test on their blood test; having a history of cataract surgery with or without intraocular lens (IOL) implantation (pseudoaphakia or aphakia) within 3 months or less prior to the screening visit; having a recent history of alcohol and/or drug abuse or excessive alcohol consumption; presenting corneal abnormalities that interfere with an accurate reading of intraocular pressure by a Goldmann applanation tonometer; being part of a clinical study within the last 12 months unless, at the discretion of the investigator, it represents a benefit to the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraocular pressure values at baseline and after 12 weeks measured through Goldmann applanation tonometry | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraocular pressure values at 2, 4, 8, and 12 weeks after randomization, before and after 2 hours of drug administration (triple fixed combination or COMBIGAN), measured through Goldmann applanation tonometry;Collection of adverse events and serious adverse events and findings on clinical, laboratory and ophthalmological exams | — |
Countries
Brazil
Contacts
Public ContactMichele Espíndola
Laboratório Daudt Oliveira Ltda.
Outcome results
None listed