[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07224542":3,"trial-entities:NCT07224542":102,"trial-summary:NCT07224542":107},{"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":20,"study_type":28,"primary_purpose":14,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":52,"secondary_outcomes":66,"sex":67,"minimum_age":68,"maximum_age":69,"healthy_volunteers":70,"eligibility_criteria":71,"std_ages":82,"locations":85,"central_contacts":95,"overall_officials":96,"references":100,"see_also_links":101},"NCT07224542","IU-24139","Smart Soft Contact Lenses for Monitoring Glaucoma","Smart Soft Contact Lenses for Continuous 24-hour Monitoring of Intraocular Pressure in Glaucoma Care","ENROLLING_BY_INVITATION","2028-09-30","2025-11","2025-11-05","2025-10-19","Indiana University","OTHER",false,"This study is exploring the effectiveness and safety of soft contact lenses with embedded sensors, called smart contact lenses. Smart contact lenses are used to measure the pressure inside the eye.","Subjects first present for a single qualification visit (phase 1), then present for up to 3 short-term (\\~1 hour) in-clinic visits (phase 2), and finally have visits prior to and following a full day (phase 3). Efficacy outcomes of the smart contact lens are compared to standard clinical measures of eye pressure. Safety outcomes of the smart contact lens are compared to those of traditional soft contact lenses.",[19],"Glaucoma",[21,22,23,24,25,26,27],"glaucoma","contact lens","sensor","eye pressure","IOP","optometry","ophthalmology","INTERVENTIONAL",[30],"NA",{"count":32,"type":33},120,"ESTIMATED",[35,41,48],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DEVICE","Bare Contact Lens","Commercially available contact lens without a sensor",[40],"Sensor Experimental Arm",{"type":36,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"Clinical IOP Measure","clinical IOP",[40],[46,47],"iCare","Goldmann",{"type":36,"name":49,"description":50,"armGroupLabels":51},"Experimental Contact Lens Sensor","Sensor contact lens being studied",[40],[53,57,60,63],{"measure":54,"description":55,"timeFrame":56},"Goldmann Applanation Intraocular Pressure","The IOP of participants will be measured with the Goldmann applanation tonometry (GAT) prior to and following device use, and in the contralateral eye during device use. A \\>2 mmHg difference in is considered clinically significantly different.","Phase 2: 1 hour on 3 days Phase 3: Up to 14 hours on 3 days",{"measure":58,"description":59,"timeFrame":56},"I-Care Tonometry Intraocular Pressure","The I-Care (I-Care, Inc.) tonometry will also be evaluated during contralateral eye device use. A \\>2 mmHg difference in is considered clinically significantly different.",{"measure":61,"description":62,"timeFrame":56},"Lens comfort","Participant-reported comfort will be assessed using a simple 100-point numeric scale where a rating of '100' represents extremely uncomfortable\u002Fintolerable and a rating of '1' perfectly comfortable\u002Fnot noticeable at all. Comfort assessments will occur prior to, during, and following all device use to allow comparisons to typical or comparator devices. A 7-point difference in ratings is considered clinically significantly different.",{"measure":64,"description":65,"timeFrame":56},"Lens Fit","Lens fit will be measured with slit lamp during lens wear and graded using the Cornea and Contact Lens Research Unit (CCLRU) grading scale, which ranges from 0 to 4 with a rating of 0 representing an optimal outcome. A difference of 1.0 grading unit will be considered clinically significant.",[],"ALL","22 Years",null,true,{"inclusion":72,"exclusion":77,"raw_text":81},[73,74,75,73,74,76],"22+ years of age","Able to wear soft contact lenses","Previously diagnosed, currently pharmaceutically treated Primary Open Angle Glaucoma (POAG)","Without glaucomatous disease",[78,79,80],"Unable to complete the study procedures","Ocular disease other than glaucoma (if applicable)","Significant acute or chronic medical, neurologic, or other illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and\u002For compromise the objectives of the study and\u002For is contradicted for soft contact lens or sensor lens use","Glaucomatous Arm Inclusion Criteria\n\n* 22+ years of age\n* Able to wear soft contact lenses\n* Previously diagnosed, currently pharmaceutically treated Primary Open Angle Glaucoma (POAG)\n\nNon-Glaucomatous (Healthy Older Adults) Arm Inclusion Criteria\n\n* 22+ years of age\n* Able to wear soft contact lenses\n* Without glaucomatous disease\n\nExclusion Criteria for all arms:\n\n* Unable to complete the study procedures\n* Ocular disease other than glaucoma (if applicable)\n* Significant acute or chronic medical, neurologic, or other illness in the patient that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and\u002For compromise the objectives of the study and\u002For is contradicted for soft contact lens or sensor lens use",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":87,"city":88,"state":89,"zip":90,"country":91,"geoPoint":92},"Indiana University - Clinical Optics Research Lab","Bloomington","Indiana","47405","United States",{"lat":93,"lon":94},39.16533,-86.52639,[],[97],{"name":98,"affiliation":13,"role":99},"Pete S Kollbaum","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":103,"biomarkers":106},[104,105],"Healthy Volunteers","Primary Open Angle Glaucoma",[],{"nct_id":4,"found":15,"summary":69,"prompt_version":69}]