[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643282":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":11,"centralContacts":40,"locations":11,"responsibleParty":46,"collaborators":11,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":11,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":11,"enrollmentInfo":57,"targetDuration":11,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":11,"overallStatus":67,"whyStopped":11,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":11},{"fullName":5,"class":6},"SpyGlass Pharma, Inc.","INDUSTRY",[8,14,18,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Bimatoprost-Drug Ring System Low Dose and Previously Implanted Commercially Available Monofocal IOL","EXPERIMENTAL",null,[13],"Drug: BIM-DRS Low Dose",{"label":15,"type":10,"description":11,"interventionNames":16},"Bimatoprost-Drug Ring System High Dose and Previously Implanted Commercially Available Monofocal IOL",[17],"Drug: BIM-DRS High Dose",{"label":19,"type":10,"description":11,"interventionNames":20},"Bimatoprost-Drug Ring System Low Dose with SpyGlass IOL (IOL with silicone pads (no drug))",[13,21],"Device: SpyGlass IOL with silicone pads (no drug)",{"label":23,"type":10,"description":11,"interventionNames":24},"Bimatoprost-Drug Ring System High Dose with SpyGlass IOL (IOL with silicone pads (no drug))",[17,21],[26,31,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":11},"DRUG","BIM-DRS Low Dose","Bimatoprost-Drug Ring System Low Dose",[9,19],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":11},"BIM-DRS High Dose","Bimatoprost-Drug Ring System High Dose",[15,23],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"DEVICE","SpyGlass IOL with silicone pads (no drug)","SpyGlass Intraocular Lens with silicone pads (no drug)",[23,19],[41],{"name":42,"role":43,"phone":44,"phoneExt":11,"email":45},"Sr. Vice President, Clinical Development","CONTACT","949-284-6904","clinical@spyglasspharma.com",{"type":47,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":58,"type":59},24,"ESTIMATED","INTERVENTIONAL",[62],"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).",[65,66],"Glaucoma","Ocular Hypertension","NOT_YET_RECRUITING","2026-06-08",{"date":70,"type":71},"2026-06-11","ACTUAL",{"date":73,"type":59},"2026-07-31",{"date":75,"type":59},"2030-03-31",{"name":5,"class":6}]