Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-29 @ 1:28 PM
Study NCT ID:
NCT01514734
Status:
TERMINATED
Last Update Posted:
2013-10-21
First Post:
2012-01-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C111827', 'term': 'brinzolamide'}, {'id': 'C571752', 'term': 'Azarga'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'alcon.medinfo@alcon.com', 'phone': '1-888-451-3937', 'title': 'Doug Hubatsch, Global Brand Leader, Medical Affairs', 'organization': 'Alcon Research, Ltd.'}, 'certainAgreement': {'otherDetails': 'Sponsor reserves the right of prior review of any publication or presentation of information related to the study.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'AZARGA', 'description': 'Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AZARGA', 'description': 'Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.89', 'spread': '4.14', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 weeks', 'description': 'Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).', 'unitOfMeasure': 'millimeters mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZARGA', 'description': 'Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AZARGA', 'description': 'Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.56', 'spread': '15.83', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Low recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-15', 'studyFirstSubmitDate': '2012-01-18', 'resultsFirstSubmitDate': '2013-08-15', 'studyFirstSubmitQcDate': '2012-01-18', 'lastUpdatePostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-08-15', 'studyFirstPostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-10-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).', 'timeFrame': '8 weeks', 'description': 'Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Primary open-angle glaucoma', 'Ocular hypertension', 'Pigment dispersion glaucoma'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18 years of age or older.\n* Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).\n* Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.\n* IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.\n* Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.\n* IOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Presence of other primary or secondary glaucoma not listed in inclusion criteria #2.\n* History of ocular herpes simplex.\n* Abnormality preventing reliable applanation tonometry.\n* Corneal dystrophies.\n* Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.\n* Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.\n* Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.\n* Progressive retinal or optic nerve disease from any cause.\n* Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study.\n* Pregnant or lactating.\n* Other protocol-defined exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT01514734', 'briefTitle': 'Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Brazil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Brazil', 'orgStudyIdInfo': {'id': 'RDG-11-191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZARGA', 'description': 'Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks', 'interventionNames': ['Drug: Brinzolamide/timolol maleate fixed combination']}], 'interventions': [{'name': 'Brinzolamide/timolol maleate fixed combination', 'type': 'DRUG', 'otherNames': ['AZARGA®'], 'description': 'Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.', 'armGroupLabels': ['AZARGA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11045-140', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Contact Alcon Call Center for Trial Locations', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Doug Hubatsch, M.Sc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}