{ "FullStudy":{ "Rank":217949, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514734", "OrgStudyIdInfo":{ "OrgStudyId":"RDG-11-191" }, "Organization":{ "OrgFullName":"Alcon Research", "OrgClass":"INDUSTRY" }, "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", "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" }, "StatusModule":{ "StatusVerifiedDate":"August 2013", "OverallStatus":"Terminated", "WhyStopped":"Low recruitment rate", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"August 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"August 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"August 15, 2013", "ResultsFirstSubmitQCDate":"August 15, 2013", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"October 21, 2013", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"August 15, 2013", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 21, 2013", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Alcon Research", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "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." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Glaucoma" ] }, "KeywordList":{ "Keyword":[ "Primary open-angle glaucoma", "Ocular hypertension", "Pigment dispersion glaucoma" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"9", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"AZARGA", "ArmGroupType":"Experimental", "ArmGroupDescription":"Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Brinzolamide/timolol maleate fixed combination" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Brinzolamide/timolol maleate fixed combination", "InterventionDescription":"Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "AZARGA" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "AZARGA®" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).", "PrimaryOutcomeDescription":"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).", "PrimaryOutcomeTimeFrame":"8 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n18 years of age or older.\nClinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).\nBe on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.\nIOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.\nBest corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.\nIOP between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.\nOther protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\nPresence of other primary or secondary glaucoma not listed in inclusion criteria #2.\nHistory of ocular herpes simplex.\nAbnormality preventing reliable applanation tonometry.\nCorneal dystrophies.\nConcurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.\nIntraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.\nRisk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.\nProgressive retinal or optic nerve disease from any cause.\nUse 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.\nPregnant or lactating.\nOther protocol-defined exclusion criteria may apply.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Doug Hubatsch, M.Sc.", "OverallOfficialAffiliation":"Alcon Research", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Contact Alcon Call Center for Trial Locations", "LocationCity":"São Paulo", "LocationZip":"11045-140", "LocationCountry":"Brazil" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"AZARGA", "FlowGroupDescription":"Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"9" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"9" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"AZARGA", "BaselineGroupDescription":"Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"9" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"58.56", "BaselineMeasurementSpread":"15.83" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Brazil", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"9" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy).", "OutcomeMeasureDescription":"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).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"millimeters mercury (mmHg)", "OutcomeMeasureTimeFrame":"8 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"AZARGA", "OutcomeGroupDescription":"Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"9" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.89", "OutcomeMeasurementSpread":"4.14" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"AZARGA", "EventGroupDescription":"Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"9", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"9" } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictionType":"OTHER", "AgreementRestrictiveAgreement":"Yes", "AgreementOtherDetails":"Sponsor reserves the right of prior review of any publication or presentation of information related to the study." }, "PointOfContact":{ "PointOfContactTitle":"Doug Hubatsch, Global Brand Leader, Medical Affairs", "PointOfContactOrganization":"Alcon Research, Ltd.", "PointOfContactEMail":"alcon.medinfo@alcon.com", "PointOfContactPhone":"1-888-451-3937" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "United States" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000013999", "InterventionMeshTerm":"Timolol" },{ "InterventionMeshId":"C000111827", "InterventionMeshTerm":"Brinzolamide" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000319", "InterventionAncestorTerm":"Adrenergic beta-Antagonists" },{ "InterventionAncestorId":"D000018674", "InterventionAncestorTerm":"Adrenergic Antagonists" },{ "InterventionAncestorId":"D000018663", "InterventionAncestorTerm":"Adrenergic Agents" },{ "InterventionAncestorId":"D000018377", "InterventionAncestorTerm":"Neurotransmitter Agents" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000889", "InterventionAncestorTerm":"Anti-Arrhythmia Agents" },{ "InterventionAncestorId":"D000000959", "InterventionAncestorTerm":"Antihypertensive Agents" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000002257", "InterventionAncestorTerm":"Carbonic Anhydrase Inhibitors" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M254051", "InterventionBrowseLeafName":"Maleic acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15340", "InterventionBrowseLeafName":"Timolol", "InterventionBrowseLeafAsFound":"Timolol maleate", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M251124", "InterventionBrowseLeafName":"Brinzolamide", "InterventionBrowseLeafAsFound":"Brinzolamide", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2252", "InterventionBrowseLeafName":"Adrenergic beta-Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19330", "InterventionBrowseLeafName":"Adrenergic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19339", "InterventionBrowseLeafName":"Adrenergic Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19088", "InterventionBrowseLeafName":"Neurotransmitter Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2794", "InterventionBrowseLeafName":"Anti-Arrhythmia Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2858", "InterventionBrowseLeafName":"Antihypertensive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M4097", "InterventionBrowseLeafName":"Carbonic Anhydrase Inhibitors", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"AnArAg", "InterventionBrowseBranchName":"Anti-Arrhythmia Agents" },{ "InterventionBrowseBranchAbbrev":"AnAg", "InterventionBrowseBranchName":"Antihypertensive Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000005901", "ConditionMeshTerm":"Glaucoma" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000009798", "ConditionAncestorTerm":"Ocular Hypertension" },{ "ConditionAncestorId":"D000005128", "ConditionAncestorTerm":"Eye Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8607", "ConditionBrowseLeafName":"Hypertension", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7596", "ConditionBrowseLeafName":"Glaucoma", "ConditionBrowseLeafAsFound":"Glaucoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M7597", "ConditionBrowseLeafName":"Glaucoma, Open-Angle", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11314", "ConditionBrowseLeafName":"Ocular Hypertension", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6854", "ConditionBrowseLeafName":"Eye Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4577", "ConditionBrowseLeafName":"Pigment-dispersion Syndrome", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC11", "ConditionBrowseBranchName":"Eye Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }