BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension

Randomized Clinical Trial to Compare the Efficacy and Safety of BREMEN Eye Drops Versus Combigan in Subjects With Open Angle Glaucoma or Ocular Hypertension

The purpose of this study is to evaluate the clinical efficacy of the BREMEN eye drops in the treatment of primary open-angle glaucoma or intraocular hypertension.

Study Overview

• Status: Completed
• Conditions: Ocular Hypertension; Primary Open-angle Glaucoma
• Intervention / Treatment: Drug: BREMEN eye drops; Drug: Combigan®

• Study Type: Interventional
• Enrollment (Actual): 406
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Roberto B. Amazonas, MD; Phone Number: +551938879851; Email: pesquisa.clinica@ems.com.br

Study Locations

• Brazil
  • São Paulo
    • Campinas, São Paulo, Brazil, 13.084-791
      • Allegisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Signed Consent;
• Participants with diagnosis of open-angle glaucoma or hypertension ocular, who needs treatment with drugs association to control the intraocular pressure;
• Participants who have 20/80 visual acuity or more, in both eyes;

Exclusion Criteria:

• Participants with any clinical significant disease that, after evaluation of the investigator, can´t participate in the study;
• Participants with active eye disease, which in the investigator opinion may interfere in the results of this clinical trial;
• Participants presenting previous diagnosis of non-operated cataract, high myopia, high astigmatism, pseudoexfoliation and corneal deformities;
• Participants who had significant visual loss in the last year;
• Treatment-naive participants for open-angle glaucoma or ocular hypertension;
• Participants nonresponders to previous triple combination drug therapy, used in concomitance;
• Participants with previous ocular or intraocular surgery within six months prior to enrollment in the clinical trial;
• Participants with history of hypersensitivity to any formula compounds;
• Participants presenting contraindications to use of beta-adrenergic antagonists;
• Participants diagnosed with uncontrolled cardiovascular disease;
• Participants with severe renal insufficiency or hyperchloremic acidosis;
• Participants in therapy with monoamine oxidase inhibitors (MAOIs);
• Participants who were in use of drugs that can interfere in the evaluation;
• Pregnancy or risk of pregnancy and lactating patients;
• Alcoholism or illicit drug abuse in the last two years;
• Participation in clinical trial in the year prior to this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BREMEN eye drops; 1 drop in affected eye(s), each 12 hours for 8 weeks.	Drug: BREMEN eye drops; 1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
Active Comparator: Combigan®; 1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.	Drug: Combigan®; 1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety will be evaluated through the adverse events occurrences	8 weeks

Collaborators and Investigators

• Sponsor: EMS

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 27, 2017
• First Posted (Actual): August 1, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Physiological Effects of Drugs; Adrenergic beta-Antagonists; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Pharmaceutical Solutions; Ophthalmic Solutions; Brimonidine Tartrate, Timolol Maleate Drug Combination
• Other Study ID Numbers: EMS0117

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No