[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100521211":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":38,"centralContacts":42,"locations":49,"responsibleParty":67,"collaborators":32,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":32,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":32,"enrollmentInfo":78,"targetDuration":32,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":32,"overallStatus":52,"whyStopped":32,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Glaukos Corporation","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"iDose TR","EXPERIMENTAL","Travoprost Intraocular Implant in subjects who had successful iStent infinite placement",[13,14],"Drug: Travoprost Intraocular Implant","Device: iStent infinite",{"label":16,"type":17,"description":18,"interventionNames":19},"iDose TR alone","ACTIVE_COMPARATOR","Travoprost Intraocular Implant",[13,20],"Other: Sham procedure",[22,27,33],{"type":23,"name":18,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","anchored intracameral implant containing travoprost",[9,16],[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","iStent infinite","Successful iStent infinite surgery",[9],null,{"type":34,"name":35,"description":36,"armGroupLabels":37,"otherNames":32},"OTHER","Sham procedure","Sham procedure (to mimic placement of an iStent infinite)",[16],[39],{"name":40,"affiliation":5,"role":41},"Study Director","STUDY_DIRECTOR",[43,47],{"name":40,"role":44,"phone":45,"phoneExt":32,"email":46},"CONTACT","949-739-8749","idoseclinical@glaukos.com",{"name":48,"role":44,"phone":45,"phoneExt":32,"email":46},"Study Manager",[50],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Glaukos Clinical Study Site","RECRUITING","Oklahoma City","Oklahoma","73112","United States","US",{"type":59,"coordinates":60},"Point",[61,62],-97.51643,35.46756,{"lat":62,"lon":61},[65],{"name":40,"role":44,"phone":45,"phoneExt":32,"email":66},"idoseclinical@Glaukos.com",{"type":68,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","100521211","phase-4-travoprost-intraocular-implant--istent-infinite-100521211",false,"NCT06066645","Travoprost Intraocular Implant + iStent Infinite","Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite in Subjects With Open-angle Glaucoma or Ocular Hypertension","Inclusion Criteria:\n\n* diagnosis of open-angle glaucoma or ocular hypertension\n* qualifying IOP in the study eye\n\nExclusion Criteria:\n\n* unmedicated (washed out) IOP of \\>36 mmHg in the study eye\n* hypersensitivity to travoprost or any other components of the travoprost intraocular implant\n* vertical cup\u002Fdisc ratio \\> 0.8 in the study eye\n* best spectacle corrected visual acuity of worse than 20\u002F80 in either eye\n* any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study","ALL","18 Years",{"count":79,"type":80},150,"ESTIMATED","INTERVENTIONAL",[83],"PHASE4","Adult subjects with elevated intraocular pressure will be randomized to receive iStent infinite trabecular bypass system plus a travoprost intraocular implant or receive a sham procedure plus a travoprost intraocular implant and be followed for 12 months.",[86],"Glaucoma, Open-Angle","2026-05-29",{"date":89,"type":90},"2026-06-02","ACTUAL",{"date":92,"type":90},"2023-09-14",{"date":94,"type":80},"2028-02",{"name":5,"class":6},1]