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

Sponsor

EMS (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03235232

Collaborator

(none)

384

Enrollment

Location

Arms

33.9

Anticipated Duration (Months)

11.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Hypertension Primary Open-angle Glaucoma	Drug: BREMEN eye drops Drug: Combigan®	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

384 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: BREMEN eye drops 1 drop in affected eye(s), each 12 hours for 8 weeks.	Drug: BREMEN eye drops 1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
Active Comparator: Combigan® 1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.	Drug: Combigan® 1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

Arm

Intervention/Treatment

Experimental: BREMEN eye drops

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

Drug: BREMEN eye drops

1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.

Active Comparator: Combigan®

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

Drug: Combigan®

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Safety will be evaluated through the adverse events occurrences [8 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.