{ "FullStudy":{ "Rank":217865, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515826", "OrgStudyIdInfo":{ "OrgStudyId":"C-10-013" }, "Organization":{ "OrgFullName":"Alcon Research", "OrgClass":"INDUSTRY" }, "BriefTitle":"VIGADEXA Gel Compared to VIGADEXA Solution Following Cataract Surgery", "OfficialTitle":"Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery" }, "StatusModule":{ "StatusVerifiedDate":"March 2014", "OverallStatus":"Withdrawn", "WhyStopped":"Management decision", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"March 2014" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2014", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"October 2014", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 19, 2012", "StudyFirstSubmitQCDate":"January 19, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"March 24, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"March 26, 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 compare VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.075%) ophthalmic gel to VIGADEXA (moxifloxacin 0.5%/dexamethasone phosphate 0.1%) ophthalmic solution in the prevention of postoperative inflammation and infection." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Cataracts" ] }, "KeywordList":{ "Keyword":[ "Cataract surgery", "Topical therapy", "Prevention of inflammation", "Inflammation of infection" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Single", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"0", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"VIGADEXA Gel", "ArmGroupType":"Experimental", "ArmGroupDescription":"VIGADEXA ophthalmic gel topically administered TID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)" ] } },{ "ArmGroupLabel":"VIGADEXA Solution", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"VIGADEXA ophthalmic solution topically administered QID to the operative eye starting the day before surgery, continuing on the day of surgery, and for 15 days following surgery.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)", "InterventionDescription":"One ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "VIGADEXA Gel" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "FID 119149, VIGADEXA Gel" ] } },{ "InterventionType":"Drug", "InterventionName":"Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)", "InterventionDescription":"One drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "VIGADEXA Solution" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "VIGADEXA Solution" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of patients with a score of 0 (<5 cells) for cells in the anterior chamber", "PrimaryOutcomeDescription":"As assessed by the investigator during slit-lamp examination.", "PrimaryOutcomeTimeFrame":"Day 15 post-operative" },{ "PrimaryOutcomeMeasure":"Percentage of patients with no clinically evidenced bacterial infection", "PrimaryOutcomeDescription":"As assessed by the investigator during slit-lamp examination.", "PrimaryOutcomeTimeFrame":"Day 15 post-operative" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Cells in the anterior chamber (study eye)", "SecondaryOutcomeDescription":"As assessed by the investigator during slit-lamp examination.", "SecondaryOutcomeTimeFrame":"Day 15 post-operative" },{ "SecondaryOutcomeMeasure":"Ocular pain (study eye)", "SecondaryOutcomeDescription":"As assessed by the investigator during patient interview.", "SecondaryOutcomeTimeFrame":"Day 15 post-operative" },{ "SecondaryOutcomeMeasure":"Inflammatory reaction (study eye)", "SecondaryOutcomeDescription":"As assessed by the investigator during slit-lamp examination.", "SecondaryOutcomeTimeFrame":"Day 15 post-operative" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\n18 years of age or older.\nDiagnosis of cataract with intention to undergo routine, uncomplicated cataract surgery.\nAble to understand and sign an informed consent form.\nOther protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\nGlaucoma or ocular hypertension.\nUse of topical or systemic non-steroidal anti-inflammatory drugs (NSAIDs) within 14 days prior to surgery or planned use during the study. Low-dose acetylsalicylic acid (up to 100 mg/day) is allowed.\nUse of anti-bacterial, anti-viral, or anti-fungal agents or ocular medications within 30 days prior to enrollment in the study or during study, as specified by protocol.\nSecondary implantation or replacement of the intra-ocular lens (IOL) in the study eye.\nPlanned use of contact lenses in the study eye during the study period.\nCataract surgery in the contralateral eye within 30 days prior to the Screening Visit, or planned for the 3 weeks after the cataract surgery in the study eye.\nHistory of clinically significant trauma to the study eye within the past 12 months.\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":[ "Brazil" ] } }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000077266", "InterventionMeshTerm":"Moxifloxacin" },{ "InterventionMeshId":"D000003907", "InterventionMeshTerm":"Dexamethasone" },{ "InterventionMeshId":"C000018038", "InterventionMeshTerm":"Dexamethasone acetate" },{ "InterventionMeshId":"D000009883", "InterventionMeshTerm":"Ophthalmic Solutions" },{ "InterventionMeshId":"C000109079", "InterventionMeshTerm":"Norgestimate, ethinyl estradiol drug combination" },{ "InterventionMeshId":"D000019999", "InterventionMeshTerm":"Pharmaceutical Solutions" },{ "InterventionMeshId":"C000004180", "InterventionMeshTerm":"Dexamethasone 21-phosphate" },{ "InterventionMeshId":"C000101468", "InterventionMeshTerm":"BB 1101" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000893", "InterventionAncestorTerm":"Anti-Inflammatory Agents" },{ "InterventionAncestorId":"D000000932", "InterventionAncestorTerm":"Antiemetics" },{ "InterventionAncestorId":"D000001337", "InterventionAncestorTerm":"Autonomic Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000005765", "InterventionAncestorTerm":"Gastrointestinal Agents" },{ "InterventionAncestorId":"D000005938", "InterventionAncestorTerm":"Glucocorticoids" },{ "InterventionAncestorId":"D000006728", "InterventionAncestorTerm":"Hormones" },{ "InterventionAncestorId":"D000006730", "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists" },{ "InterventionAncestorId":"D000018931", "InterventionAncestorTerm":"Antineoplastic Agents, Hormonal" },{ "InterventionAncestorId":"D000000970", "InterventionAncestorTerm":"Antineoplastic Agents" },{ "InterventionAncestorId":"D000011480", "InterventionAncestorTerm":"Protease Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000045504", "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action" },{ "InterventionAncestorId":"D000000900", "InterventionAncestorTerm":"Anti-Bacterial Agents" },{ "InterventionAncestorId":"D000000890", "InterventionAncestorTerm":"Anti-Infective Agents" },{ "InterventionAncestorId":"D000059005", "InterventionAncestorTerm":"Topoisomerase II Inhibitors" },{ "InterventionAncestorId":"D000059003", "InterventionAncestorTerm":"Topoisomerase Inhibitors" },{ "InterventionAncestorId":"D000003277", "InterventionAncestorTerm":"Contraceptives, Oral, Combined" },{ "InterventionAncestorId":"D000003276", "InterventionAncestorTerm":"Contraceptives, Oral" },{ "InterventionAncestorId":"D000003271", "InterventionAncestorTerm":"Contraceptive Agents, Female" },{ "InterventionAncestorId":"D000003270", "InterventionAncestorTerm":"Contraceptive Agents" },{ "InterventionAncestorId":"D000012102", "InterventionAncestorTerm":"Reproductive Control Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M20444", "InterventionBrowseLeafName":"Pharmaceutical Solutions", "InterventionBrowseLeafAsFound":"Solution", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M11397", "InterventionBrowseLeafName":"Ophthalmic Solutions", "InterventionBrowseLeafAsFound":"Ophthalmic solution", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M5685", "InterventionBrowseLeafName":"Dexamethasone", "InterventionBrowseLeafAsFound":"Dexamethasone", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M243574", "InterventionBrowseLeafName":"Dexamethasone acetate", "InterventionBrowseLeafAsFound":"Dexamethasone", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M205479", "InterventionBrowseLeafName":"BB 1101", "InterventionBrowseLeafAsFound":"Dexamethasone", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M1722", "InterventionBrowseLeafName":"Moxifloxacin", "InterventionBrowseLeafAsFound":"Moxifloxacin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M252530", "InterventionBrowseLeafName":"Dexamethasone 21-phosphate", "InterventionBrowseLeafAsFound":"Dexamethasone Phosphate", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M140649", "InterventionBrowseLeafName":"Norgestimate, ethinyl estradiol drug combination", "InterventionBrowseLeafAsFound":"Moxifloxacin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M204621", "InterventionBrowseLeafName":"Estradiol 3-benzoate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M237310", "InterventionBrowseLeafName":"Estradiol 17 beta-cypionate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M6691", "InterventionBrowseLeafName":"Estradiol", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M242995", "InterventionBrowseLeafName":"Polyestradiol phosphate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M6728", "InterventionBrowseLeafName":"Ethinyl Estradiol", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M211303", "InterventionBrowseLeafName":"Norgestimate", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2798", "InterventionBrowseLeafName":"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2832", "InterventionBrowseLeafName":"Antiemetics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7464", "InterventionBrowseLeafName":"Gastrointestinal Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7630", "InterventionBrowseLeafName":"Glucocorticoids", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8372", "InterventionBrowseLeafName":"Hormones", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M8371", "InterventionBrowseLeafName":"Hormone Antagonists", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19550", "InterventionBrowseLeafName":"Antineoplastic Agents, Hormonal", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12926", "InterventionBrowseLeafName":"Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M18192", "InterventionBrowseLeafName":"HIV Protease Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2803", "InterventionBrowseLeafName":"Anti-Bacterial Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2795", "InterventionBrowseLeafName":"Anti-Infective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5077", "InterventionBrowseLeafName":"Contraceptive Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5083", "InterventionBrowseLeafName":"Contraceptives, Oral", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M5084", "InterventionBrowseLeafName":"Contraceptives, Oral, Combined", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"PhSol", "InterventionBrowseBranchName":"Pharmaceutical Solutions" },{ "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"ANeo", "InterventionBrowseBranchName":"Antineoplastic Agents" },{ "InterventionBrowseBranchAbbrev":"AnEm", "InterventionBrowseBranchName":"Antiemetics" },{ "InterventionBrowseBranchAbbrev":"Gast", "InterventionBrowseBranchName":"Gastrointestinal Agents" },{ "InterventionBrowseBranchAbbrev":"Infe", "InterventionBrowseBranchName":"Anti-Infective Agents" },{ "InterventionBrowseBranchAbbrev":"Repr", "InterventionBrowseBranchName":"Reproductive Control Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000002386", "ConditionMeshTerm":"Cataract" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000007905", "ConditionAncestorTerm":"Lens Diseases" },{ "ConditionAncestorId":"D000005128", "ConditionAncestorTerm":"Eye Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4221", "ConditionBrowseLeafName":"Cataract", "ConditionBrowseLeafAsFound":"Cataract", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M8876", "ConditionBrowseLeafName":"Inflammation", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9500", "ConditionBrowseLeafName":"Lens Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6854", "ConditionBrowseLeafName":"Eye Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC11", "ConditionBrowseBranchName":"Eye Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }