[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07048886":3,"trial-entities:NCT07048886":106,"trial-summary:NCT07048886":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":45,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":14,"eligibility_criteria":53,"std_ages":74,"locations":77,"central_contacts":95,"overall_officials":99,"references":104,"see_also_links":105},"NCT07048886","CFS-RAPRAM-101","Rocklatan Adds Pressure Reduction After MIGS (Minimally Invasive Glaucoma Surgery)","NOT_YET_RECRUITING","2026-12-31","2025-06","2025-07-03","2025-07-15","Center for Sight Las Vegas","OTHER",false,"The primary objective of this study is to determine if the addition of Rocklatan post-Hydrus will provide additional intraocular pressure lowering.","The study is a prospective single-practice with multiple locations, single-surgeon, parallel double arm study in subjects with open angle glaucoma (OAG), who were implanted with Hydrus microstent combined with cataract surgery to be randomized to receive Rocklatan vs. Comparator (artificial tears). Unmedicated MDIOP (mean diurnal intraocular pressure) measurements will be assessed at baseline (after Hydrus, prior to study medication) and at 1-month post-initiation of Study Drop.",[18],"Primary Open Angle Glaucoma",[18,20],"Rocklatan","INTERVENTIONAL","TREATMENT",[24],"PHASE4",{"count":26,"type":27},68,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Rocklatan (netarsudil 0.02% and latanoprost 0.005%)","Additional intraocular eye pressure lowering post-Hydrus",[34],"FDA Approved Rocklatan (netarsudil 0.02% and latanoprost 0.005%)",{"type":30,"name":36,"description":37,"armGroupLabels":38},"Systane","Placebo Comparator (artificial tears)",[39],"Placebo Comparator Systane Artificial Tears",[41],{"measure":42,"description":43,"timeFrame":44},"Mean diurnal intraocular pressure change from baseline","After Hydrus prior to study initiation drop","After 28 days up to 35 days post initiation of Rocklatan vs placebo comparator",[46],{"measure":47,"description":48,"timeFrame":49},"Diurnal Intraocular pressure change from baseline and difference between intraocular pressure at each time point","Goldmann Applanation Tonometry","After Hydrus prior to study drop and after 28 days up to 35 days post initiation of study drop for all time points 8am, 10am, 4pm (± 1 hour) between groups","ALL","40 Years",null,{"inclusion":54,"exclusion":60,"raw_text":73},[55,56,57,58,59],"Age 40 years and older","Subjects who have mild to moderate Open Angle Glaucoma (OAG)","Subjects who have undergone uncomplicated cataract surgery and Hydrus microstent implantation \\> 3 months prior to screening and within the last 2 years","Post-Hydrus subjects on 0-2 ocular hypotensive medication classes who can safely washout (if on ocular hypotensive medications)","Unmedicated or washed out IOP range between 16-26 mmHg",[61,62,63,64,65,66,67,68,69,70,71,72],"History of intraocular surgery except for uneventful refractive surgery or uncomplicated cataract surgery and hydrus microstent implantation","Prior Selective Laser Trabeculoplasty (SLT) within 18 months of surgery","Secondary glaucoma excluding pseudoexfoliation and pigmentary dispersion syndrome","Severe Open Angle Glaucoma","Narrow angles, other angle abnormalities or angle closure glaucoma","Allergy or intolerance to Rocklatan","History of corneal edema, or corneal disease or dystrophy","Current or history of intra-ocular infection or inflammation","History of retinal diseases that could affect diagnostic testing","Anticipated use of intra-ocular or topical steroids not associated with the study protocol","Pregnant, breastfeeding or planning to become pregnant during the study","Any condition in the opinion in the investigator that would potentially confound the results of the study","Inclusion Criteria:\n\n* Age 40 years and older\n* Subjects who have mild to moderate Open Angle Glaucoma (OAG)\n* Subjects who have undergone uncomplicated cataract surgery and Hydrus microstent implantation \\> 3 months prior to screening and within the last 2 years\n* Post-Hydrus subjects on 0-2 ocular hypotensive medication classes who can safely washout (if on ocular hypotensive medications)\n* Unmedicated or washed out IOP range between 16-26 mmHg\n\nExclusion Criteria:\n\n* History of intraocular surgery except for uneventful refractive surgery or uncomplicated cataract surgery and hydrus microstent implantation\n* Prior Selective Laser Trabeculoplasty (SLT) within 18 months of surgery\n* Secondary glaucoma excluding pseudoexfoliation and pigmentary dispersion syndrome\n* Severe Open Angle Glaucoma\n* Narrow angles, other angle abnormalities or angle closure glaucoma\n* Allergy or intolerance to Rocklatan\n* History of corneal edema, or corneal disease or dystrophy\n* Current or history of intra-ocular infection or inflammation\n* History of retinal diseases that could affect diagnostic testing\n* Anticipated use of intra-ocular or topical steroids not associated with the study protocol\n* Pregnant, breastfeeding or planning to become pregnant during the study\n* Any condition in the opinion in the investigator that would potentially confound the results of the study",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":92},"Center for Sight","Las Vegas","Nevada","89145","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"Clinical Research Manager","CONTACT","702-724-2005","jodi.kennedy@c4slv.com",{"name":91,"role":87},"Clinical Research Coordinator",{"lat":93,"lon":94},36.17497,-115.13722,[96,97],{"name":86,"role":87,"phone":88,"email":89},{"name":91,"role":87,"phone":98},"702-724-2067",[100],{"name":101,"affiliation":102,"role":103},"Medical Director, Medical Doctor","Center For Sight","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":107,"biomarkers":108},[18],[],{"nct_id":4,"found":110,"summary":111,"prompt_version":121},true,{"design":112,"status":113,"heading":114,"summary":115,"follow_up":116,"word_count":117,"commitments":118,"compensation":119,"drugs_mentioned":120},"This study will involve 68 participants and is designed as a randomized, double-blind study, meaning you would be randomly assigned to receive either Rocklatan or Systane, and neither you nor your doctor would know which one you are receiving.","completed","Rocklatan for Pressure Reduction After Glaucoma Surgery","This study is looking at whether adding Rocklatan (a combination eye drop of netarsudil and latanoprost) can further lower eye pressure in people with primary open-angle glaucoma (a common eye condition that damages the optic nerve) who have already had cataract surgery and a Hydrus microstent (a tiny device to help drain fluid from the eye) implanted. You might be able to join if you are 40 or older, have mild to moderate open-angle glaucoma, and had your Hydrus microstent implanted between 3 months and 2 years ago. The main goal is to see how much Rocklatan changes your eye pressure compared to a placebo (Systane artificial tears) after about one month. The study is currently recruiting participants.","Your eye pressure will be measured again about 28 to 35 days after you start using the study eye drops.",118,"You would have your eye pressure measured at the start of the study and again about one month after you begin using the study eye drops.","Not stated in the trial record.",[36],"v2"]