[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609762":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":40,"centralContacts":45,"locations":51,"responsibleParty":71,"collaborators":11,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":11,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":11,"enrollmentInfo":82,"targetDuration":11,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":11,"overallStatus":54,"whyStopped":11,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"SpyGlass Pharma, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Bimatoprost Implant System \u002F IOL Combination","EXPERIMENTAL",null,[13,14],"Drug: Bimatoprost Implant System","Device: SpyGlass IOL",{"label":16,"type":17,"description":11,"interventionNames":18},"Timolol Maleate Ophthalmic Solution 0.5%","ACTIVE_COMPARATOR",[19,20],"Drug: Timolol Maleate Ophthalmic Solution, 0.5%","Device: Commercial IOL",[22,27,32,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":11},"DRUG","Bimatoprost Implant System","Bimatoprost Implant System used in combination with the SpyGlass IOL",[9],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DEVICE","SpyGlass IOL","SpyGlass Intraocular Lens",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"Timolol Maleate Ophthalmic Solution, 0.5%","Timolol Maleate Ophthalmic Solution, 0.5% BID",[16],{"type":28,"name":37,"description":38,"armGroupLabels":39,"otherNames":11},"Commercial IOL","Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens",[16],[41],{"name":42,"affiliation":43,"role":44},"Paul Yoo, OD","SpyGlass Pharma","STUDY_CHAIR",[46],{"name":47,"role":48,"phone":49,"phoneExt":11,"email":50},"Director, Clinical Affairs","CONTACT","949-284-6904","clinical@spyglasspharma.com",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"R and R Eye Research, LLC","RECRUITING","San Antonio","Texas","78229","United States","US",{"type":61,"coordinates":62},"Point",[63,64],-98.49363,29.42412,{"lat":64,"lon":63},[67],{"name":68,"role":48,"phone":69,"phoneExt":11,"email":70},"Clinical Research Coordinator","2104242584","maggie@eye-assoc.com",{"type":72,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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",false,"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","ALL","22 Years",{"count":83,"type":84},400,"ESTIMATED","INTERVENTIONAL",[87],"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.",[90,91,92],"Cataract","Glaucoma","Ocular Hypertension","2025-10-16",{"date":95,"type":96},"2025-10-20","ACTUAL",{"date":98,"type":84},"2025-10-28",{"date":100,"type":84},"2031-05-31",{"name":5,"class":6},1]