{ "FullStudy":{ "Rank":218297, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510145", "OrgStudyIdInfo":{ "OrgStudyId":"RDG-10-300" }, "Organization":{ "OrgFullName":"Alcon Research", "OrgClass":"INDUSTRY" }, "BriefTitle":"Efficacy of Changing to TRAVATAN® From Prior Therapy", "OfficialTitle":"Multi-Center Study Comparing Efficacy and Tolerability of TRAVATAN® BAK-free (0.004% Travoprost) in Patients Previously on Latanoprost Ophthalmic Solution 0.005% Monotherapy" }, "StatusModule":{ "StatusVerifiedDate":"May 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"February 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"May 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"May 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 11, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 13, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"May 15, 2014", "ResultsFirstSubmitQCDate":"May 15, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"June 13, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"May 15, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"June 13, 2014", "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 TRAVATAN® solution without BAK (benzalkonium chloride) after changing from prior latanoprost 0.005% ophthalmic solution monotherapy in subjects with open-angle glaucoma or ocular hypertension due to tolerability issues." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Open-angle Glaucoma", "Ocular Hypertension" ] }, "KeywordList":{ "Keyword":[ "Glaucoma", "Open-angle glaucoma", "Ocular hypertension", "Hypertension", "Eye Diseases", "Vascular Diseases", "Cardiovascular Diseases", "Travoprost", "Antihypertensive Agents", "Cardiovascular Agents", "Therapeutic Uses", "Pharmacologic Actions" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"191", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"TRAVATAN® BAK-free", "ArmGroupType":"Experimental", "ArmGroupDescription":"Travoprost 0.004% BAK-free, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Travoprost 0.004% BAK-free" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Travoprost 0.004% BAK-free", "InterventionDescription":"Containing Polyquad (PQ) preservative", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "TRAVATAN® BAK-free" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "TRAVATAN® BAK-free" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)", "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 12" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of Subjects Who Reach Target IOP (≤18 mmHg)", "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 12" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nClinical diagnosis of ocular hypertension or open-angle glaucoma in at least one eye;\nOn latanoprost ophthalmic solution 0.005% monotherapy (including BAK-containing generics) for at least 4 weeks prior to the Screening Visit, but would benefit from a switch to TRAVATAN® BAK-free because of tolerability issues, in the opinion of the investigator;\nIntraocular pressure (IOP) <30 millimeters of mercury (mmHg) in both eyes while on latanoprost ophthalmic solution 0.005% monotherapy;\nIOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that assured clinical stability of vision and the optic nerve throughout the study period;\nWilling to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study;\nAble to follow instructions and willing and able to attend all study visits;\nBest corrected Snellen visual acuity of 6/60 (20/200; 1.0 LogMAR) or better in each eye;\nMust sign an informed consent form;\nOther protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\nKnown medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in this study deemed clinically significant in the opinion of the Principal Investigator;\nAny abnormality preventing reliable applanation tonometry in either eye;\nCorneal dystrophies in either eye;\nConcurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye;\nAny clinically significant, serious, or severe medical condition;\nUse of any systemic medications known to affect IOP which have not been on a stable course for at least 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the study;\nSevere dry eye or keratoconjunctivitis sicca which has been or is currently being treated with the use of punctal plugs, punctal cautery, Restasis®, or topical ocular corticosteroids;\nIntraocular conventional surgery or laser surgery in either eye less than 3 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;\nWomen who are pregnant, lactating, or not using reliable means of birth control;\nOther protocol-defined exclusion criteria may apply.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Adriana S. Bonadia", "OverallOfficialAffiliation":"Alcon Research", "OverallOfficialRole":"Study Director" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"26563363", "ReferenceType":"derived", "ReferenceCitation":"Lopes JF, Hubatsch DA, Amaris P. Effect of benzalkonium chloride-free travoprost on intraocular pressure and ocular surface symptoms in patients with glaucoma previously on latanoprost: an open-label study. BMC Ophthalmol. 2015 Nov 12;15:166. doi: 10.1186/s12886-015-0151-7." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"This reporting group includes all enrolled patients (191).", "FlowRecruitmentDetails":"Patients were recruited from 4 study centers located in Argentina, 4 study centers located in Chile, and 2 study centers located in Colombia.", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"TRAVATAN® BAK-free", "FlowGroupDescription":"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"191" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"173" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"18" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"6" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"5" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"6" } ] } },{ "FlowDropWithdrawType":"Relative reported subject withdrew", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"1" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"This analysis population includes all enrolled patients.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"TRAVATAN® BAK-free", "BaselineGroupDescription":"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks." } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"191" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"67.5", "BaselineMeasurementSpread":"11.3" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"139" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"52" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Change in Intraocular Pressure (IOP) at 12 Weeks From Prior Therapy (Baseline)", "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":"This analysis population includes all patients who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"mmHg", "OutcomeMeasureTimeFrame":"Baseline, Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"TRAVATAN® BAK-free", "OutcomeGroupDescription":"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"191" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.8", "OutcomeMeasurementSpread":"3.4" } ] } } ] } },{ "OutcomeClassTitle":"Change from baseline at Week 12", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.09", "OutcomeMeasurementSpread":"2.96" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Subjects Who Reach Target IOP (≤18 mmHg)", "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":"This anaylysis population includes all subjects who instilled at least one drop of study product and who had primary endpoints measures available for at least one on-therapy study visit.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"percentage of patients", "OutcomeMeasureTimeFrame":"Week 12", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"TRAVATAN® BAK-free", "OutcomeGroupDescription":"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"191" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"93.3" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"5", "EventsTimeFrame":"Adverse events (AEs) were collected for the duration of the study (1 year, 3 months). This analysis group includes all patients who instilled at least one drop of test article.", "EventsDescription":"AE data were collected and reported in the eCRF at each visit from time of first drug instillation to Week 12.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"TRAVATAN® BAK-free", "EventGroupDescription":"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"191", "EventGroupOtherNumAffected":"0", "EventGroupOtherNumAtRisk":"191" } ] } }, "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":"D000069557", "InterventionMeshTerm":"Travoprost" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000959", "InterventionAncestorTerm":"Antihypertensive Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M466", "InterventionBrowseLeafName":"Travoprost", "InterventionBrowseLeafAsFound":"Travoprost", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2858", "InterventionBrowseLeafName":"Antihypertensive Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"AnAg", "InterventionBrowseBranchName":"Antihypertensive Agents" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000005901", "ConditionMeshTerm":"Glaucoma" },{ "ConditionMeshId":"D000005902", "ConditionMeshTerm":"Glaucoma, Open-Angle" },{ "ConditionMeshId":"D000009798", "ConditionMeshTerm":"Ocular Hypertension" },{ "ConditionMeshId":"D000006973", "ConditionMeshTerm":"Hypertension" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" },{ "ConditionAncestorId":"D000005128", "ConditionAncestorTerm":"Eye Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M6854", "ConditionBrowseLeafName":"Eye Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8607", "ConditionBrowseLeafName":"Hypertension", "ConditionBrowseLeafAsFound":"Hypertension", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M7596", "ConditionBrowseLeafName":"Glaucoma", "ConditionBrowseLeafAsFound":"Glaucoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M7597", "ConditionBrowseLeafName":"Glaucoma, Open-Angle", "ConditionBrowseLeafAsFound":"Open Angle Glaucoma", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11314", "ConditionBrowseLeafName":"Ocular Hypertension", "ConditionBrowseLeafAsFound":"Ocular Hypertension", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"T4577", "ConditionBrowseLeafName":"Pigment-dispersion Syndrome", "ConditionBrowseLeafAsFound":"Open Angle Glaucoma", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"BC11", "ConditionBrowseBranchName":"Eye Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }