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

EMS

Status and phase: Completed; Phase 3

Conditions: Ocular Hypertension; Primary Open-angle Glaucoma

Treatments: Drug: BREMEN eye drops; Drug: Combigan®

Study type: Interventional

Funder types: Industry

Identifiers

NCT03235232

EMS0117

Details and patient eligibility

About

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.

Enrollment: 406 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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406 participants in 2 patient groups

BREMEN eye drops

Experimental group

Description:

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

Treatment:

Drug: BREMEN eye drops

Combigan®

Active Comparator group

Description:

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

Treatment:

Drug: Combigan®