{ "FullStudy":{ "Rank":217950, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01514721", "OrgStudyIdInfo":{ "OrgStudyId":"RDG-11-171" }, "Organization":{ "OrgFullName":"Alcon Research", "OrgClass":"INDUSTRY" }, "BriefTitle":"Efficacy of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination) From Prior Therapy", "OfficialTitle":"Assessing the Efficacy and Tolerability of Changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-Free Fixed Combination), as Replacement Therapy in Patients Previously on Prior Prostaglandin Fixed Combination" }, "StatusModule":{ "StatusVerifiedDate":"December 2014", "OverallStatus":"Terminated", "WhyStopped":"low enrollment", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"June 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"November 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"November 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 18, 2012", "StudyFirstSubmitQCDate":"January 18, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 23, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"December 2, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"December 3, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Alcon Research", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to assess efficacy and tolerability of changing to DuoTrav® (Travoprost 0.004%/Timolol 0.5% BAK-free) from prior Xalacom® or Ganfort® fixed combination pharmacotherapy in patients with open-angle glaucoma or ocular hypertension with uncontrolled intraocular pressure (IOP)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Glaucoma" ] }, "KeywordList":{ "Keyword":[ "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":"37", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"DuoTrav", "ArmGroupType":"Experimental", "ArmGroupDescription":"Travoprost/Timolol Maleate BAK-Free Fixed Combination, 1 drop self-administered in treated eye(s) once a day for 12 weeks", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Travoprost/Timolol Maleate BAK-Free Fixed Combination" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Travoprost/Timolol Maleate BAK-Free Fixed Combination", "InterventionDescription":"Commercially marketed Travoprost/Timolol BAK-free ophthalmic solution indicated for the treatment of patients with open angle glaucoma (OAG) or ocular hypertension (OH).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "DuoTrav" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "DuoTrav®" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change in intra-ocular pressure (IOP) at final visit from prior therapy (i.e., from baseline)", "PrimaryOutcomeDescription":"Goldmann applanation tonometry will be performed at the baseline visit and the 12-week visit to record IOP. Change in IOP will be calculated. IOP will be measured in mmHg.", "PrimaryOutcomeTimeFrame":"12 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Percentage of patients who reach target IOP (≤18mmHg)", "SecondaryOutcomeDescription":"Goldmann applanation tonometry will be performed at the 12-week visit to record IOP. Percentage of patients who reach target IOP will be calculated by comparing patients with IOP ≤18mmHg to the overall study population.", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Change in Ocular Surface Disease Index (OSDI) score at final visit from baseline", "SecondaryOutcomeDescription":"An OSDI questionnaire will be completed by the subject at the baseline visit and at the 12-week visit. For each visit, an overall OSDI score will be calculated using individual item responses, and the change in OSDI score from baseline will be calculated.", "SecondaryOutcomeTimeFrame":"12 weeks" },{ "SecondaryOutcomeMeasure":"Change in ocular hyperemia score at final visit from baseline", "SecondaryOutcomeDescription":"Ocular hyperemia will be assessed by qualified personnel at the baseline visit and again at the 12-week visit, and change from baseline will be calculated.", "SecondaryOutcomeTimeFrame":"12 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nClinical diagnosis of ocular hypertension, open-angle glaucoma, or pigment dispersion glaucoma in both eyes.\nOn a stable IOP-lowering regimen of prostaglandin fixed combination (either Xalacom or Ganfort) within 4 weeks prior to the Screening Visit.\nIOP between 19 and 35 mmHg at any time of day in at least 1 eye.\nBest corrected visual acuity (BCVA) of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.\nWilling to discontinue the use of all other ocular hypotensive medication(s) prior to receiving the study medication for the entire course of the study.\nOther protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\nKnown medical history of allergy, hypersensitivity, or poor tolerance to any component of DuoTrav® deemed clinically significant in the opinion of the Principal Investigator.\nCorneal dystrophies in either eye.\nRisk of visual field or VA worsening as a consequence of participation in the study, in the investigator's best judgment.\nAny disease or condition that would preclude the safe administration of a topical beta-blocker, present a special risk to the subject, or interfere with optimal participation in the study.\nWomen who are pregnant or lactating.\nParticipation in any other investigational study within 30 days prior to the Screening Visit.\nOther protocol-defined exclusion criteria may apply.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Abayomi Ogundele, PharmD", "OverallOfficialAffiliation":"Alcon Research", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Alcon Investigational Site", "LocationCity":"Sao Paulo", "LocationCountry":"Brazil" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020", "RemovedCountryList":{ "RemovedCountry":[ "United States" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000013999", "InterventionMeshTerm":"Timolol" },{ "InterventionMeshId":"D000069557", "InterventionMeshTerm":"Travoprost" } ] }, "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" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M254051", "InterventionBrowseLeafName":"Maleic acid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M15340", "InterventionBrowseLeafName":"Timolol", "InterventionBrowseLeafAsFound":"Timolol maleate", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M466", "InterventionBrowseLeafName":"Travoprost", "InterventionBrowseLeafAsFound":"Travoprost", "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" } ] }, "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" } ] } } } } } }