Ignite Creation Date:
2025-12-24 @ 9:48 PM
Ignite Modification Date:
2026-01-01 @ 5:06 PM
Study NCT ID:
NCT03235232
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2017-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D005901', 'term': 'Glaucoma'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068599', 'term': 'Brimonidine Tartrate, Timolol Maleate Drug Combination'}], 'ancestors': [{'id': 'D013999', 'term': 'Timolol'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000068438', 'term': 'Brimonidine Tartrate'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 406}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-15', 'studyFirstSubmitDate': '2017-07-27', 'studyFirstSubmitQcDate': '2017-07-27', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy based in the reduction of intraocular pressure in patients with open-angle glaucoma or hypertension ocular.', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety will be evaluated through the adverse events occurrences', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ocular Hypertension', 'Primary Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed Consent;\n* Participants with diagnosis of open-angle glaucoma or hypertension ocular, who needs treatment with drugs association to control the intraocular pressure;\n* Participants who have 20/80 visual acuity or more, in both eyes;\n\nExclusion Criteria:\n\n* Participants with any clinical significant disease that, after evaluation of the investigator, can´t participate in the study;\n* Participants with active eye disease, which in the investigator opinion may interfere in the results of this clinical trial;\n* Participants presenting previous diagnosis of non-operated cataract, high myopia, high astigmatism, pseudoexfoliation and corneal deformities;\n* Participants who had significant visual loss in the last year;\n* Treatment-naive participants for open-angle glaucoma or ocular hypertension;\n* Participants nonresponders to previous triple combination drug therapy, used in concomitance;\n* Participants with previous ocular or intraocular surgery within six months prior to enrollment in the clinical trial;\n* Participants with history of hypersensitivity to any formula compounds;\n* Participants presenting contraindications to use of beta-adrenergic antagonists;\n* Participants diagnosed with uncontrolled cardiovascular disease;\n* Participants with severe renal insufficiency or hyperchloremic acidosis;\n* Participants in therapy with monoamine oxidase inhibitors (MAOIs);\n* Participants who were in use of drugs that can interfere in the evaluation;\n* Pregnancy or risk of pregnancy and lactating patients;\n* Alcoholism or illicit drug abuse in the last two years;\n* Participation in clinical trial in the year prior to this study.'}, 'identificationModule': {'nctId': 'NCT03235232', 'briefTitle': 'BREMEN Eye Drops Versus Combigan for Open-angle Glaucoma or Intraocular Hypertension', 'organization': {'class': 'INDUSTRY', 'fullName': 'EMS'}, 'officialTitle': 'Randomized Clinical Trial to Compare the Efficacy and Safety of BREMEN Eye Drops Versus Combigan in Subjects With Open Angle Glaucoma or Ocular Hypertension', 'orgStudyIdInfo': {'id': 'EMS0117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BREMEN eye drops', 'description': '1 drop in affected eye(s), each 12 hours for 8 weeks.', 'interventionNames': ['Drug: BREMEN eye drops']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Combigan®', 'description': '1 drop of Combigan® in affected eye(s), each 12 hours for 8 weeks.', 'interventionNames': ['Drug: Combigan®']}], 'interventions': [{'name': 'BREMEN eye drops', 'type': 'DRUG', 'description': '1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.', 'armGroupLabels': ['BREMEN eye drops']}, {'name': 'Combigan®', 'type': 'DRUG', 'description': '1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.', 'armGroupLabels': ['Combigan®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13.084-791', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Allegisa', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'EMS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}