Clinical trial
Randomized Clinical Trial to Compare the Efficacy and Safety of BREMEN Eye Drops Versus Combigan in Subjects With Open Angle Glaucoma or Ocular Hypertension
Name
EMS0117
Description
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.
Trial arms
Trial start
2021-02-01
Estimated PCD
2023-07-31
Trial end
2023-10-31
Status
Completed
Phase
Early phase I
Treatment
BREMEN eye drops
1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
Arms:
BREMEN eye drops
Combigan®
1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
Arms:
Combigan®
Size
406
Primary endpoint
Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.
8 weeks
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}}, 'enrollmentInfo': {'count': 406, 'type': 'ACTUAL'}}
Updated at
2024-02-20
1 organization
2 products
2 indications
Organization
EMSProduct
BREMENIndication
ocular hypertensionIndication
Primary Open-angle GlaucomaProduct
Combigan®