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

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Clinical Trial to Compare the Efficacy and Safety of BREMEN Eye Drops Versus Combigan in Subjects With Open Angle Glaucoma or Ocular Hypertension

Conditions
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Ocular Hypertension, Primary Open-angle Glaucoma

Intervention / Treatment
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* Drug: BREMEN eye drops
* Drug: Combigan®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular. |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be evaluated through the adverse events occurrences |  | 8 weeks |