[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06848946":3,"trial-entities:NCT06848946":84,"trial-summary:NCT06848946":90},{"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":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":47,"healthy_volunteers":15,"eligibility_criteria":48,"std_ages":56,"locations":59,"central_contacts":73,"overall_officials":78,"references":82,"see_also_links":83},"NCT06848946","GLK-101-04","Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone","Multicenter, Randomized, Double-masked, Parallel Group Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intracameral Implant) in Conjunction With Cataract Surgery vs. Cataract Surgery Alone","RECRUITING","2027-06","2026-01","2026-01-21","2025-01-13","Glaukos Corporation","INDUSTRY",false,"This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone","This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).",[19,20,21],"Glaucoma, Open-angle","Ocular Hypertension (OHT)","Phacoemulsification Cataract Surgery",[],"INTERVENTIONAL","TREATMENT",[26],"PHASE4",{"count":28,"type":29},132,"ESTIMATED",[31,35],{"type":32,"name":33,"description":33,"armGroupLabels":34},"COMBINATION_PRODUCT","iDose TR (travoprost intracameral implant) 75 µg in conjunction with cataract surgery",[33],{"type":36,"name":37,"description":37,"armGroupLabels":38},"PROCEDURE","Sham procedure in conjunction with cataract surgery",[37],[40],{"measure":41,"description":42,"timeFrame":43},"Change from baseline in mean diurnal IOP","Mean diurnal IOP at the Month 3 Visit minus mean diurnal IOP at the Baseline Visit","3 Months",[],"ALL","45 Years",null,{"inclusion":49,"exclusion":52,"raw_text":55},[50,51],"Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.","OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)",[53,54],"Active corneal inflammation or edema.","Retinal disorders not associated with glaucoma.","Inclusion Criteria:\n\n* Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.\n* OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)\n\nExclusion Criteria:\n\n* Active corneal inflammation or edema.\n* Retinal disorders not associated with glaucoma.",[57,58],"ADULT","OLDER_ADULT",[60],{"facility":61,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":70},"Glaukos Investigator Site","Kenosha","Wisconsin","53142","United States",[67],{"role":68,"email":69},"CONTACT","idose@glaukos.com",{"lat":71,"lon":72},42.58474,-87.82119,[74],{"name":75,"role":68,"phone":76,"email":77},"Study Manager","949-739-8749","ClinicalResearch@glaukos.com",[79],{"name":80,"affiliation":13,"role":81},"Study Director","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":85,"biomarkers":89},[86,87,88],"Cataract","Ocular Hypertension","Open Angle Glaucoma",[],{"nct_id":4,"found":91,"summary":92,"prompt_version":102},true,{"design":93,"status":94,"heading":95,"summary":96,"follow_up":97,"word_count":98,"commitments":99,"compensation":100,"drugs_mentioned":101},"This is a Phase 4, randomized, double-masked study involving 132 participants. It compares two groups: one receiving iDose TR during cataract surgery and another receiving a sham procedure during cataract surgery.","completed","iDose TR with Cataract Surgery for Glaucoma or Ocular Hypertension","This study is looking at the safety and effectiveness of iDose TR (a travoprost implant) when given during cataract surgery. It compares this approach to cataract surgery alone for people with open-angle glaucoma (OAG) or ocular hypertension (OHT), which is high pressure in the eye. You might be able to join if you are 45 or older, need cataract surgery, and have OAG or OHT. The main goal is to see how much the eye pressure changes after 3 months. The study is currently unclear on its recruitment status.","Participants will be followed for at least 3 months to measure changes in eye pressure.",89,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]