[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"SpyGlass Pharma, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,40,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100643282","phase-1-evaluation-of-the-safety-efficacy-dose-response-of-the-bimatoprost-drug-ring-system-bim-drs-in-pseudophakic-patients-diagnosed-with-open-angle-glaucoma-or-ocular-hypertension-100643282",false,"NCT07641296","Evaluation of the Safety, Efficacy, Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Diagnosed With Open Angle Glaucoma or Ocular Hypertension","Prospective, Multi-Center, Open-Label, Non-Randomized, Multi-Arm Study to Evaluate the Safety, Efficacy, and Dose Response of the Bimatoprost Drug Ring System (BIM-DRS) in Pseudophakic Patients Implanted With a Posterior Chamber Intraocular Lens (PC-IOL) and Diagnosed With Mild to Moderate Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT)","Inclusion Criteria:\n\n* Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension\n* Pseudophakic or planned removal of cataract\n* Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease\n* History of incisional\u002Frefractive corneal surgery\n* Any glaucoma diagnosis other than OHT, open-angle, or pigmentary glaucoma\n* History of incisional glaucoma surgery\n* Other ocular diseases, pathology, or conditions","ALL","22 Years",{"count":19,"type":20},24,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to learn if two different doses of the SpyGlass Bimatoprost-Drug Ring System (BIM-DRS) work to treat adult pseudophakic patients with either glaucoma or ocular hypertension. The main question it aims to answer is:\n\nDoes the BIM-DRS lower the pressure inside the eye to treat glaucoma or ocular hypertension?\n\nResearchers will compare two different doses of the BIM-DRS implanted either with a pre-existing commercially available monofocal intraocular lens (IOL) or concurrently with the SpyGlass IOL (IOL with silicone pads (no drug)).\n\nParticipants will:\n\n* Upon providing informed consent and successfully completing the screening visit, stop taking their IOP lowering medications in the eye to be treated.\n* Complete a baseline visit to further evaluate eligibility in the study eye.\n* Undergo surgery to implant the BIM-DRS (BIM-DRS and SpyGlass IOL for Cohorts 3 and 4). Only one eye of each participant will be treated.\n* Complete post-operative follow-up visits for evaluation at Day 1, Week 2, Week 6, Month 3, Month 6, Month 12, Month 18, Month 24, Month 30, and Month 36 (last study visit).",[26,27],"Glaucoma","Ocular Hypertension","NOT_YET_RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-11","ACTUAL",{"date":34,"type":20},"2026-07-31",{"date":36,"type":20},"2030-03-31",{"name":38,"class":39},"SpyGlass Pharma, Inc.","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100609762","phase-3-evaluation-of-the-safety-and-efficacy-of-the-bimatoprost-implant-system-used-in-combination-with-the-spyglass-iol-compared-to-timolol-ophthalmic-solution-rhone-100609762","NCT07218796","Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhone)","A Prospective, Multicenter, Randomized, Masked, Controlled Study to Evaluate the Safety and Efficacy of the Bimatoprost Implant System (78 mcg) Used in Combination With the SpyGlass IOL Compared to Timolol Maleate Ophthalmic Solution, USP, 0.5%,","Inclusion Criteria:\n\n* Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension\n* Planned removal of cataract\n* Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease\n* History of incisional\u002Frefractive corneal surgery\n* Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliative, or pigmentary glaucoma\n* History of incisional glaucoma surgery or intraocular injections\n* Other ocular diseases, pathology, or conditions",{"count":48,"type":20},400,[50],"PHASE3","This trial is a randomized study to evaluate the Bimatoprost Implant System used in combination with the SpyGlass IOL to Timolol Ophthalmic Solution in participants with mild to moderate open-angle glaucoma or ocular hypertension undergoing cataract surgery.",[53,26,27],"Cataract","RECRUITING","2025-10-16",{"date":57,"type":32},"2025-10-20",{"date":59,"type":20},"2025-10-28",{"date":61,"type":20},"2031-05-31",{"name":38,"class":39},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":70,"briefSummary":51,"conditions":71,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":63},"100609761","phase-3-evaluation-of-the-safety-and-efficacy-of-the-bimatoprost-implant-system-used-in-combination-with-the-spyglass-iol-compared-to-timolol-ophthalmic-solution-rhine-100609761","NCT07218783","Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compared to Timolol Ophthalmic Solution (Rhine)",{"count":48,"type":20},[50],[53,26,27],{"date":57,"type":32},{"date":74,"type":32},"2025-10-15",{"date":76,"type":20},"2031-03-31",{"name":38,"class":39},""]