{
  "FullStudy":{
    "Rank":217738,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01517477",
          "OrgStudyIdInfo":{
            "OrgStudyId":"GCF-033"
          },
          "Organization":{
            "OrgFullName":"Glaukos Corporation",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects",
          "OfficialTitle":"A Prospective, Randomized, Controlled Evaluation of Open-Angle Glaucoma Subjects on Two Topical Hypotensive Medications, Implanted With One, Two, or Three Trabecular Micro-Bypass Stents"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2018",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"June 2018",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"December 2018",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 23, 2012",
          "StudyFirstSubmitQCDate":"January 24, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 25, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 7, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 9, 2018",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Glaukos Corporation",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to evaluate the safety and efficacy of the intraocular pressure (IOP) lowering effect of one, two, or three iStent devices in eyes of subjects previously on two anti-glaucoma medications."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Primary Open Angle Glaucoma (POAG)"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Open angle",
              "Glaucoma",
              "surgery",
              "Glaucoma, Open-Angle",
              "Ocular Hypertension",
              "Eye Diseases"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"251",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"First Arm: One iStent",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Device: One iStent",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: iStent"
                  ]
                }
              },{
                "ArmGroupLabel":"Second Arm: Two iStents",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Device: Two iStent devices",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: iStent"
                  ]
                }
              },{
                "ArmGroupLabel":"Third Arm: Three iStents",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Device: Three iStent devices",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Device: iStent"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Device",
                "InterventionName":"iStent",
                "InterventionDescription":"Implantation of One iStent through a small temporal clear corneal incision.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "First Arm: One iStent"
                  ]
                }
              },{
                "InterventionType":"Device",
                "InterventionName":"iStent",
                "InterventionDescription":"Implantation of Two iStents through a small temporal clear corneal incision",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Second Arm: Two iStents"
                  ]
                }
              },{
                "InterventionType":"Device",
                "InterventionName":"iStent",
                "InterventionDescription":"Implantation of Three iStents through a small temporal clear corneal incision",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Third Arm: Three iStents"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Mean diurnal intraocular pressure (IOP) reduction of greater than or equal to 20% at month 12 vs. baseline",
                "PrimaryOutcomeTimeFrame":"12 Months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Mean diurnal IOP <18 mmHg at month 12",
                "SecondaryOutcomeTimeFrame":"12 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nDiagnosed with primary open-angle glaucoma (POAG)\nSubject on two topical hypotensive medications\n\nExclusion Criteria:\n\nTraumatic, uveitic, neovascular, or angle closure glaucoma\nFellow eye already enrolled",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"S.V. Malayan's Ophthalmology Centre",
                "LocationCity":"Yerevan",
                "LocationZip":"375108",
                "LocationCountry":"Armenia"
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"Yes",
          "IPDSharingDescription":"18 month results published in Clinical Ophthalmology 2015:9 2313-2320."
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000005901",
                "ConditionMeshTerm":"Glaucoma"
              },{
                "ConditionMeshId":"D000005902",
                "ConditionMeshTerm":"Glaucoma, Open-Angle"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000009798",
                "ConditionAncestorTerm":"Ocular Hypertension"
              },{
                "ConditionAncestorId":"D000005128",
                "ConditionAncestorTerm":"Eye Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M6854",
                "ConditionBrowseLeafName":"Eye Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8607",
                "ConditionBrowseLeafName":"Hypertension",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "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",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "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"
              }
            ]
          }
        }
      }
    }
  }
}