[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595750":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":40,"centralContacts":41,"locations":46,"responsibleParty":59,"collaborators":40,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":40,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":40,"enrollmentInfo":70,"targetDuration":40,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":49,"whyStopped":40,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"EyeD Pharma","INDUSTRY",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"TimoD implant - Dose 1 (low dose)","EXPERIMENTAL","Participants in Group 1 will receive a low dose of TimoD implant in the study eye on Day 1.",[13,14],"Drug: TimoD implant","Device: Injector system",{"label":16,"type":10,"description":17,"interventionNames":18},"TimoD implant - Dose 2 (intermediate dose)","Participants in Group 2 will receive an intermediate dose of TimoD implant in the study eye on Day 1 if all participants in Group 1 have completed a 4-week treatment period with the lowest dose of TimoD implant and providing there are no safety issues in Group 1.",[13,14],{"label":20,"type":10,"description":21,"interventionNames":22},"TimoD implant - Dose 3 (high dose)","Participants in Group 3 will receive a high dose of TimoD implant in the study eye on Day 1 if all participants in Group 2 have completed a 4-week treatment period with the intermediate dose, providing there are no safety issues in Group 2.",[13,14],[24,32],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","TimoD implant","Consists of 1 TimoD implant administration in the study eye.",[9,16,20],[30,31],"intraocular implant releasing timolol","investigational drug",{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DEVICE","Injector system","This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as an\"intraocular implant injection system\" outside of its scope of intended use.",[9,16,20],[38,39],"ACCUJECT™ 2.2.-BL","Investigational device",null,[42],{"name":5,"role":43,"phone":44,"phoneExt":40,"email":45},"CONTACT","+3242299000","dpo@eyedpharma.com",[47],{"facility":48,"status":49,"city":50,"state":40,"zip":40,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":40},"Panama Eye Center","RECRUITING","Panama City","Panama","PA",{"type":54,"coordinates":55},"Point",[56,57],-79.51973,8.9936,{"lat":57,"lon":56},{"type":60,"investigatorFullName":40,"investigatorTitle":40,"investigatorAffiliation":40,"oldNameTitle":40,"oldOrganization":40},"SPONSOR","100595750","phase-1-safety-of-timod-sustained-release-implant-in-participants-with-glaucoma-or-ocular-hypertension-undergoing-cataract-surgery-100595750",false,"NCT07036510","Safety of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery","Early Feasibility, Open-Label, Dose-Escalating, Non-Randomized Study to Evaluate the Safety of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery","Inclusion Criteria:\n\n* Capable of giving signed informed consent.\n* In good general and mental health without ongoing clinically significant abnormalities in medical history.\n* Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement.\n* successful, uncomplicated cataract surgery\n\nExclusion Criteria:\n\n* Subjects with a history of hypersensitivity or contraindications to β- blockers.\n* Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure\n* Significant risks caused by washout of ocular hypotensive medications.\n* Clinically significant ocular pathology other than OHT, glaucoma and cataract","ALL","40 Years",{"count":71,"type":72},18,"ESTIMATED","INTERVENTIONAL",[75],"PHASE1","The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery.\n\nThe main questions it aims to answer are how safe are three different doses of the investigational drug is and how the body tolerates it.\n\nThe study will also check:\n\n* how safely the implant is placed in and removed from the eye and how the body responds to the procedure,\n* if and the amount of Timolol released in the bloodstream,\n* if there is any positive effect on the pressure inside the eye.",[78,79],"Glaucoma","Ocular Hypertension",[78,81,82,83,84,85],"Ocular hypertension","OHT","Cataract","Timolol","Lens diseases","2025-06-17",{"date":88,"type":89},"2025-06-25","ACTUAL",{"date":91,"type":89},"2025-06-12",{"date":93,"type":72},"2027-01",{"name":5,"class":6},1]