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

Phase 3

Completed

• Conditions: Ocular Hypertension; Primary Open-angle Glaucoma
• Interventions: Drug: Combigan®; Drug: BREMEN eye drops

• Registration Number: NCT03235232
• Lead Sponsor: EMS

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-07-27
• Study First Posted: 2017-08-01
• Study Start: 2021-02-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-10-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Combigan®	Combigan®	1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.
BREMEN eye drops	BREMEN eye drops	1 drop in affected eye(s), each 12 hours for 8 weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety will be evaluated through the adverse events occurrences	8 weeks

Trial Locations

Locations (1)

Allegisa; 🇧🇷 Campinas, São Paulo, Brazil