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

• Status: Recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EMS
• Treatments: Brimonidine Tartrate, Timolol Maleate Drug Combination; Brinzolamide; Ophthalmic Solutions; Tetrahydrozoline

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.