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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03235232
• Other study ID #: EMS0117
• Status: Completed
• Phase: Phase 3
• Start date: February 1, 2021
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: October 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Primary Open-angle Glaucoma

Intervention

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

Locations

Country	Name	City	State
Brazil	Allegisa	Campinas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.		8 weeks
Secondary	Safety will be evaluated through the adverse events occurrences		8 weeks