Back to resultsBREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension
Primary Purpose
Ocular Hypertension, Primary Open-angle Glaucoma
Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
BREMEN eye drops
Combigan®
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Hypertension
Eligibility 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.
Sites / Locations
- AllegisaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BREMEN eye drops
Combigan®
Arm Description
1 drop in affected eye(s), each 12 hours for 8 weeks.
1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.
Outcomes
Primary Outcome Measures
Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.
Secondary Outcome Measures
Safety will be evaluated through the adverse events occurrences
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03235232
Brief Title
BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Hypertension, Primary Open-angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
384 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
BREMEN eye drops
Arm Type
Experimental
Arm Description
1 drop in affected eye(s), each 12 hours for 8 weeks.
Arm Title
Combigan®
Arm Type
Active Comparator
Arm Description
1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
BREMEN eye drops
Intervention Description
1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Combigan®
Intervention Description
1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
Primary Outcome Measure Information:
Title
Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Safety will be evaluated through the adverse events occurrences
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto B. Amazonas, MD
Phone
+551938879851
Email
pesquisa.clinica@ems.com.br
Facility Information:
Facility Name
Allegisa
City
Campinas
State/Province
São Paulo
ZIP/Postal Code
13.084-791
Country
Brazil
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension
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