Clinical trial to compare the efficacy and safety between the combination of dorzolamide hydrochloride (2%) + brimonidine tartrate (0.2%) + timolol maleate (0.5%) and COMBIGAN® (combination of 0.2% brimonidine tartrate + 0.5% timolol maleate) in reducing ocular pressure in adult patients with primary open-angle glaucoma or high pressure in the eyes

Phase 3

• Conditions: Primary open-angle glaucoma; ocular hypertension; open-angle glaucoma; glaucoma suspicion; C11.525.381.407; C11.525; H40.1; H40.0

• Registration Number: RBR-3crsfj
• Lead Sponsor: aboratório Daudt Oliveira Ltda.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-20
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intraocular pressure values at baseline and after 12 weeks measured through Goldmann applanation tonometry

Secondary Outcome Measures

Name	Time	Method
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