BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension
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 |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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
Inclusion Criteria:
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Signed Consent;
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Participants with diagnosis of open-angle glaucoma or hypertension ocular, who needs treatment with drugs association to control the intraocular pressure;
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Participants who have 20/80 visual acuity or more, in both eyes;
Exclusion Criteria:
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Participants with any clinical significant disease that, after evaluation of the investigator, can´t participate in the study;
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Participants with active eye disease, which in the investigator opinion may interfere in the results of this clinical trial;
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Participants presenting previous diagnosis of non-operated cataract, high myopia, high astigmatism, pseudoexfoliation and corneal deformities;
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Participants who had significant visual loss in the last year;
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Treatment-naive participants for open-angle glaucoma or ocular hypertension;
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Participants nonresponders to previous triple combination drug therapy, used in concomitance;
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Participants with previous ocular or intraocular surgery within six months prior to enrollment in the clinical trial;
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Participants with history of hypersensitivity to any formula compounds;
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Participants presenting contraindications to use of beta-adrenergic antagonists;
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Participants diagnosed with uncontrolled cardiovascular disease;
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Participants with severe renal insufficiency or hyperchloremic acidosis;
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Participants in therapy with monoamine oxidase inhibitors (MAOIs);
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Participants who were in use of drugs that can interfere in the evaluation;
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Pregnancy or risk of pregnancy and lactating patients;
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Alcoholism or illicit drug abuse in the last two years;
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Participation in clinical trial in the year prior to this study.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Allegisa | Campinas | São Paulo | Brazil | 13.084-791 |
Sponsors and Collaborators
- EMS
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EMS0117