{ "FullStudy":{ "Rank":217679, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518244", "OrgStudyIdInfo":{ "OrgStudyId":"RDG-11-198" }, "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 Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America", "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 Latin America" }, "StatusModule":{ "StatusVerifiedDate":"February 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"February 25, 2014", "ResultsFirstSubmitQCDate":"February 25, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"April 4, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 17, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"August 7, 2015", "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 participants 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":"50", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"AZARGA®", "ArmGroupType":"Experimental", "ArmGroupDescription":"Brinzolamide/timolol maleate fixed combination, 1 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", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "AZARGA®" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "AZARGA®" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8", "PrimaryOutcomeDescription":"IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.", "PrimaryOutcomeTimeFrame":"Baseline, Week 8" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8", "SecondaryOutcomeDescription":"IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.", "SecondaryOutcomeTimeFrame":"Week 8" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nClinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).\nOn a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.\nIOP considered safe in both eyes in order to 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.\nHistory of ocular herpes simplex.\nAny abnormality 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 Screening Visit.\nRisk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.\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 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", "OverallOfficialAffiliation":"Alcon Research", "OverallOfficialRole":"Study Director" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"This reporting group includes all participants who received at least one dose of AZARGA®.", "FlowRecruitmentDetails":"Participants were recruited from 6 study centers located in South America: Argentina (3), Chile (1), and Mexico (2).", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"AZARGA®", "FlowGroupDescription":"Brinzolamide/timolol maleate fixed combination, 1 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":"50" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"47" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"3" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"3" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"The analysis population includes all participants who received AZARGA® and with at least one on-therapy study visit (V2 or V3). Of the 50 enrolled, 1 participant discontinued after V1 and before V2.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"AZARGA®", "BaselineGroupDescription":"Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"49" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"66.67", "BaselineMeasurementSpread":"11.51" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"30" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"19" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8", "OutcomeMeasureDescription":"IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.", "OutcomeMeasurePopulationDescription":"The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"milllimeters mercury (mmHg)", "OutcomeMeasureTimeFrame":"Baseline, Week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"AZARGA®", "OutcomeGroupDescription":"Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"49" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-3.60", "OutcomeMeasurementSpread":"3.01" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8", "OutcomeMeasureDescription":"IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.", "OutcomeMeasurePopulationDescription":"The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of participants", "OutcomeMeasureTimeFrame":"Week 8", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"AZARGA®", "OutcomeGroupDescription":"Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"49" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"55.3" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events (AEs) were collected for the duration of the study (December 2011-February 2013). An AE was defined as any untoward medical occurrence in a subject administered the test product, regardless of causal relationship with such product.", "EventsDescription":"The analysis population includes all participants who received at least one dose of AZARGA®.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"AZARGA®", "EventGroupDescription":"Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"50", "EventGroupOtherNumAffected":"4", "EventGroupOtherNumAtRisk":"50" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Eye irritation", "OtherEventOrganSystem":"Eye disorders", "OtherEventSourceVocabulary":"MedDRA 15.1", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumAffected":"4", "OtherEventStatsNumAtRisk":"50" } ] } } ] } }, "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" } ] } } } } } }