Status:
COMPLETED
BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension
Lead Sponsor:
EMS
Conditions:
Ocular Hypertension
Primary Open-angle Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2023
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT03235232
Start Date
February 1 2021
End Date
October 31 2023
Last Update
February 20 2024
Active Locations (1)
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1
Allegisa
Campinas, São Paulo, Brazil, 13.084-791