Ocular Hypertension, Primary Open-angle Glaucoma
Conditions
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.
Interventions
DRUGBREMEN eye drops
1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
DRUGCombigan®
1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular. | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Safety will be evaluated through the adverse events occurrences | 8 weeks |
Countries
Brazil
Outcome results
None listed