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

NCT ID: NCT03235232

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-10-31

Brief Summary

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.

Conditions

Ocular Hypertension; Primary Open-angle Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BREMEN eye drops

1 drop in affected eye(s), each 12 hours for 8 weeks.

Group Type: EXPERIMENTAL

BREMEN eye drops

Intervention Type: DRUG

1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

Combigan®

1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Combigan®

Intervention Type: DRUG

1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

Interventions

BREMEN eye drops

1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

Intervention Type: DRUG

Combigan®

1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EMS

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Allegisa

Campinas, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EMS0117

Identifier Type: -

Identifier Source: org_study_id