[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496926":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":35,"locations":40,"responsibleParty":58,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":68,"sex":69,"minAge":70,"maxAge":25,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":25,"overallStatus":80,"whyStopped":25,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"iRenix Medical, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"IRX-101","EXPERIMENTAL","Subjects randomized to IRX-101 will receive the investigational product, IRX-101.",[13],"Drug: IRX-101",{"label":15,"type":16,"description":17,"interventionNames":18},"5% Povidone-iodine","ACTIVE_COMPARATOR","Subjects randomized to this arm will receive the standard of care, Providone-iodine, at a concentration of 5%.",[19],"Drug: Providone-Iodine",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","IRX-101 is a novel ocular anti-septic",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Providone-Iodine","5% Providone-Iodine",[15],[31],{"name":32,"affiliation":33,"role":34},"Stephen Smith, MD","Founder","STUDY_CHAIR",[36],{"name":32,"role":37,"phone":38,"phoneExt":25,"email":39},"CONTACT","650-785-1316","stephen@irenix.com",[41],{"facility":42,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"R. Gary Lane, II MD","San Antonio","Texas","78240","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-98.49363,29.42412,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":25,"email":25},"Francisco Angueira","800-833-5921",{"type":59,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100496926","phase-3-safety-and-tolerability-of-irx-101-in-patients-receiving-intravitreal-injections-100496926",false,"NCT05750589","Safety and Tolerability of IRX-101 in Patients Receiving Intravitreal Injections","Randomized, Controlled, Double-Masked Study to Evaluate the Efficacy of IRX-101 in Reducing Post-Intravitreal Pain and Corneal Epitheliopathy","COMFORT","Inclusion Criteria:\n\n1. Capable of giving informed consent\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, ≥ 18 years of age and receiving intravitreal anti-VEGF injections in one or both eyes\n\nExclusion Criteria:\n\n1. Current or past diagnosis of endophthalmitis\n2. Current diagnosis of uveitis\n3. Monocular patients (vision 20\u002F100 or worse in one eye) who are receiving injections in the better seeing eye\n4. Current use of viscous lidocaine products for ocular anesthesia prior to IVT\n5. Currently receiving intravitreal steroid injections\n6. Concurrent participation in another clinical trial\n7. Females who are pregnant, planning to become pregnant or lactating",true,"ALL","18 Years",{"count":72,"type":73},240,"ESTIMATED","INTERVENTIONAL",[76],"PHASE3","This is a randomized, double-masked study to evaluate the tolerability and safety of IRX-101 versus 5% povidone-iodine (PI) in subjects receiving intravitreal anti-VEGF injections.",[79],"Retinal Disease","NOT_YET_RECRUITING","2026-03-30",{"date":83,"type":84},"2026-04-03","ACTUAL",{"date":86,"type":73},"2026-09-01",{"date":88,"type":73},"2027-12-31",{"name":5,"class":6},1]