[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07218796":3,"trial-entities:NCT07218796":17,"trial-summary:NCT07218796":17},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":51,"secondary_outcomes":60,"sex":64,"minimum_age":65,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":66,"std_ages":78,"locations":81,"central_contacts":97,"overall_officials":102,"references":107,"see_also_links":108},"NCT07218796","SGP-006","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%,","RECRUITING","2031-05-31","2025-10","2025-10-20","2025-10-28","SpyGlass Pharma, Inc.","INDUSTRY",false,"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.",null,[19,20,21],"Cataract","Glaucoma","Ocular Hypertension",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE3",{"count":28,"type":29},400,"ESTIMATED",[31,37,42,47],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Bimatoprost Implant System","Bimatoprost Implant System used in combination with the SpyGlass IOL",[36],"Bimatoprost Implant System \u002F IOL Combination",{"type":38,"name":39,"description":40,"armGroupLabels":41},"DEVICE","SpyGlass IOL","SpyGlass Intraocular Lens",[36],{"type":32,"name":43,"description":44,"armGroupLabels":45},"Timolol Maleate Ophthalmic Solution, 0.5%","Timolol Maleate Ophthalmic Solution, 0.5% BID",[46],"Timolol Maleate Ophthalmic Solution 0.5%",{"type":38,"name":48,"description":49,"armGroupLabels":50},"Commercial IOL","Commercially Available Aspheric Monofocal Non-Yellow Chromophore Intraocular Lens",[46],[52,56],{"measure":53,"description":54,"timeFrame":55},"Mean IOP Reduction from Baseline (mmHg)","Time-matched mean IOP change from Baseline in the study eyes at all the individual IOP timepoints","Weeks 2 and 6, and Month 3",{"measure":57,"description":58,"timeFrame":59},"BCDVA 20\u002F40 or better","Study eyes achieving best corrected distance visual acuity (BCDVA) of 20\u002F40 or better","Month 6",[61],{"measure":53,"description":62,"timeFrame":63},"Time matched mean IOP reduction from Baseline (mmHg) in the study eyes at all the individual IOP timepoints","Month 6, 9 and 12","ALL","22 Years",{"inclusion":67,"exclusion":71,"raw_text":77},[68,69,70],"Diagnosis of mild to moderate open-angle glaucoma or ocular hypertension","Planned removal of cataract","Female participants of childbearing potential must have a negative urine pregnancy test at the baseline visit and agree to the use of contraception",[72,73,74,75,76],"Uncontrolled systemic disease","History of incisional\u002Frefractive corneal surgery","Any glaucoma diagnosis other than OHT, open-angle, pseudoexfoliative, or pigmentary glaucoma","History of incisional glaucoma surgery or intraocular injections","Other ocular diseases, pathology, or conditions","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",[79,80],"ADULT","OLDER_ADULT",[82],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"contacts":88,"geoPoint":94},"R and R Eye Research, LLC","San Antonio","Texas","78229","United States",[89],{"name":90,"role":91,"phone":92,"email":93},"Clinical Research Coordinator","CONTACT","2104242584","maggie@eye-assoc.com",{"lat":95,"lon":96},29.42412,-98.49363,[98],{"name":99,"role":91,"phone":100,"email":101},"Director, Clinical Affairs","949-284-6904","clinical@spyglasspharma.com",[103],{"name":104,"affiliation":105,"role":106},"Paul Yoo, OD","SpyGlass Pharma","STUDY_CHAIR",[],[109],{"label":110,"url":111},"SpyGlass Pharma Website","https:\u002F\u002Fwww.spyglasspharma.com\u002F"]