Ocular Hypertension Clinical Trial
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
Verified date | February 2024 |
Source | EMS |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 406 |
Est. completion date | October 31, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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, canĀ“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. |
Country | Name | City | State |
---|---|---|---|
Brazil | Allegisa | Campinas | São Paulo |
Lead Sponsor | Collaborator |
---|---|
EMS |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular. | 8 weeks | ||
Secondary | Safety will be evaluated through the adverse events occurrences | 8 weeks |
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