{ "FullStudy":{ "Rank":218298, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01510132", "OrgStudyIdInfo":{ "OrgStudyId":"C-11-012" }, "Organization":{ "OrgFullName":"Alcon Research", "OrgClass":"INDUSTRY" }, "BriefTitle":"Travacom Post Marketing Surveillance Study", "OfficialTitle":"Post Marketing Surveillance Study to Evaluate the Safety Profile of Travacom (Travoprost/Timolol Fixed Combination) in Patients With Open-Angle Glaucoma or Ocular Hypertension Across India" }, "StatusModule":{ "StatusVerifiedDate":"October 2012", "OverallStatus":"Withdrawn", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2012", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"January 2012", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 11, 2012", "StudyFirstSubmitQCDate":"January 11, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 13, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"October 16, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"October 18, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Alcon Research", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this multi-center, open label, single arm, post-marketing surveillance study is to assess the safety of Travacom in patients with open-angle glaucoma or ocular hypertension who are insufficiently responsive to beta-blockers, prostaglandins, or other intraocular pressure-lowering (IOP) medication and when use of Travacom is considered appropriate." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Open-angle Glaucoma", "Ocular Hypertension" ] }, "KeywordList":{ "Keyword":[ "OAG", "OHT" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"0", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Travacom", "ArmGroupType":"Experimental", "ArmGroupDescription":"Travoprost/timolol fixed combination self-administered at the rate of 1 drop per eye, one time a day, at approximately 8 a.m. each day for 8 weeks.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Travoprost/timolol fixed combination (Travacom)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Travoprost/timolol fixed combination (Travacom)", "InterventionDescription":"Commercially-marketed drug for the treatment of open-angle glaucoma or ocular hypertension", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Travacom" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Travacom" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Extent of exposure", "PrimaryOutcomeDescription":"Extent of exposure is calculated as days on therapy. Days on therapy is defined as the difference in days between the date of exit (last) instillation as recorded on the last visit and the visit at which medication was first administered.", "PrimaryOutcomeTimeFrame":"Up to 8 weeks" },{ "PrimaryOutcomeMeasure":"Adverse events", "PrimaryOutcomeDescription":"Any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the study treatment, whether or not related to the treatment. Adverse events will be collected spontaneously and systematically at each scheduled study visit and may be collected at any unscheduled visit that occurs during the study. Adverse events will be documented on Adverse Events Forms and will be reported by MedDRA preferred terminology.", "PrimaryOutcomeTimeFrame":"Up to 8 weeks" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n18 years of age or older.\nOpen-angle glaucoma or ocular hypertension insufficiently responsive to betablockers, prostaglandins, or other intraocular pressure-lowering (IOP) agents and when the use of Travacom is considered appropriate.\nDiscontinued use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.\nMean IOP not greater than 36 mmHG in either eye.\nRead, sign, and date (or legal representative) the Informed Consent prior to the start of any study-related procedures.\nOther protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\nWomen of childbearing potential (not postmenopausal for at least one year or not surgically sterile) who are currently pregnant, have a positive result on the urine pregnancy test at Screening, intend to become pregnant during the study period, are breastfeeding, or do not agree to use an adequate birth control method to prevent pregnancy throughout the study.\nChronic, recurrent, or severe inflammatory eye disease, such as scleritis, uveitis, or herpes keratitis.\nHistory of clinically significant or progressive retinal disease.\nBest corrected visual acuity (BCVA) score worse than 20/80 Snellen.\nBronchial asthma or related history that would preclude safe administration of a topical beta-blocker.\nSevere, unstable, or uncontrolled cardiovascular, hepatic, or renal disease or related history that would preclude safe administration of a topical beta-adrenergic blocking agent.\nHistory of spontaneous or current hypoglycemia or uncontrolled diabetes.\nKnown medical allergy, hypersensitivity, or poor tolerance to any component of Travacom deemed clinically significant in the opinion of the Principal Investigator.\nUse of any additional topical or system ocular hypotensive medication during the study.\nParticipation in any other investigational study within 30 days prior to Screening visit.\nOther protocol-defined exclusion criteria may apply.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } } }, "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":"M15340", "InterventionBrowseLeafName":"Timolol", "InterventionBrowseLeafAsFound":"Timolol", "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":"AnArAg", "InterventionBrowseBranchName":"Anti-Arrhythmia Agents" },{ "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":"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":"M11314", "ConditionBrowseLeafName":"Ocular Hypertension", "ConditionBrowseLeafAsFound":"Ocular Hypertension", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6854", "ConditionBrowseLeafName":"Eye Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"T4577", "ConditionBrowseLeafName":"Pigment-dispersion Syndrome", "ConditionBrowseLeafAsFound":"Open Angle Glaucoma", "ConditionBrowseLeafRelevance":"high" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC11", "ConditionBrowseBranchName":"Eye Diseases" },{ "ConditionBrowseBranchAbbrev":"Rare", "ConditionBrowseBranchName":"Rare Diseases" } ] } } } } } }