[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05285553":3,"trial-entities:NCT05285553":315,"trial-summary:NCT05285553":318},{"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":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":38,"secondary_outcomes":53,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":14,"eligibility_criteria":63,"std_ages":81,"locations":83,"central_contacts":307,"overall_officials":308,"references":313,"see_also_links":314},"NCT05285553","PAS001\u002FBC","MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms","ACTIVE_NOT_RECRUITING","2030-06-30","2026-07","2026-07-08","2022-06-25","CooperVision, Inc.","INDUSTRY",true,"The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US and to assess the stability of the myopia reduction over one-year post-treatment.","This study is a multicenter, parallel-group, controlled, double-masked (subject and investigator), randomized clinical trial with a total duration of four years.\n\nPart 1 of this study will study the effectiveness of MiSight 1 Day in slowing myopia progression over three years in a US population. Subjects in Part 1 will wear MiSight 1 Day lenses or Proclear 1 day lenses.\n\nPart 2 will study the stability of the effectiveness result over a one-year post-treatment period. All subjects in Part 2 will wear Proclear 1 day lenses. Subjects and investigators will remain masked from Part 1.",[18],"Myopia",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},900,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DEVICE","MiSight 1 Day","Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.",[33],"MiSight 1 day",{"type":29,"name":35,"description":36,"armGroupLabels":37},"Proclear 1 day","Part 1 of the study - subjects will be randomized to wear Proclear 1 day for three years.\n\nPart 2 of the study - All the subjects will wear Proclear 1 day lenses for one year.",[35],[39,43,46,50],{"measure":40,"description":41,"timeFrame":42},"Mean difference in cycloplegic SERE change from baseline","Mean difference in cycloplegic SERE change from baseline; measured with cycloplegic auto-refraction in Diopters","3 years",{"measure":44,"description":45,"timeFrame":42},"Mean difference in axial length change from baseline","Mean difference in axial length change from baseline between the MiSight 1 Day group and control lens group, measured in millimeters",{"measure":47,"description":48,"timeFrame":49},"Mean difference in rate of cycloplegic SERE change - Part 2 study","Mean difference in rate of cycloplegic SERE change between the Part 1 MiSight 1 Day group and the Part 1 control lens group over one-year post-treatment; measured with cycloplegic auto-refraction in Diopters","1 year",{"measure":51,"description":52,"timeFrame":49},"Mean difference in rate of axial length - Part 2 study","Mean difference in rate of axial length change between the Part 1 MiSight 1 Day group and Part 1 control lens group over one-year post-treatment.",[54,57],{"measure":55,"description":56,"timeFrame":42},"Percentage of subjects with no appreciable myopic progression","Percentage of subjects with no appreciable myopic progression (-0.25D change or less)",{"measure":58,"description":59,"timeFrame":42},"Visual symptoms and the effects on activities of daily living","Visual symptoms and the effects on activities of daily living are measured using a validated PRO Measure","ALL","8 Years","12 Years",{"inclusion":64,"exclusion":65,"raw_text":80},[],[66,67,68,69,70,71,72,73,74,75,76,77,78,79],"Acute and subacute inflammation or infection of the anterior chamber of the eye.","Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.","Severe insufficiency of lacrimal secretion (dry eyes).","Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.","Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.","Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.","Any active corneal infection (bacterial, fungal, or viral).","If eyes are red or irritated.","The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so. 5. Has history of:","Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.","Giant papillary conjunctivitis","Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses","A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.","Corneal hypoesthesia (reduced corneal sensitivity) 6. Keratoconus or an irregular cornea. 7. Strabismus or amblyopia. 8. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.","Inclusion Criteria:\n\n1. Informed Consent and Assent have been completed\n2. Be between 8 and 12 years of age inclusive at the time of enrollment.\n3. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye\n4. Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20\u002F25 Snellen equivalent) or better in each eye.\n5. Anisometropia: ≤ 1.50D SERE.\n6. Astigmatism: ≤ 0.75 D\n7. Free of ocular disease or abnormalities (including any corneal scar)\n8. Currently have good general health.\n9. Agree to accept the lens as assigned by the randomization.\n10. Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.\n11. Ability to comply with study procedures, including high and low (sub-study only) contrast high and low (sub-study only) lighting visual acuity, axial length, and cycloplegic auto-refraction measurements taken for both eyes.\n12. Able to maintain the visit schedule.\n13. Willingness to participate in the trial for 4 years.\n14. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.\n15. Possesses, or obtains prior to dispensing, wearable and visually functional (20\u002F40 or better) eyeglasses.\n\nExclusion Criteria:\n\n1. Current or prior use of any pharmaceuticals or other methods for control of myopia, such as bifocals, progressive addition lenses, orthokeratology, atropine, pirenzepine or any other myopia control treatment.\n2. Use of any systemic or topical ocular medications or over-the-counter artificial tears which might interfere with contact lens wear, pupil size, accommodation or refractive state, or require the lenses to be removed during the day.\n3. Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses\n4. Has any of the following specific contraindications to MiSight 1 Day lenses at Baseline Visit:\n\n   * Acute and subacute inflammation or infection of the anterior chamber of the eye.\n   * Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.\n   * Severe insufficiency of lacrimal secretion (dry eyes).\n   * Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.\n   * Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.\n   * Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.\n   * Any active corneal infection (bacterial, fungal, or viral).\n   * If eyes are red or irritated.\n   * The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.\n5. Has history of:\n\n   * Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections.\n   * Giant papillary conjunctivitis\n   * Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses\n   * A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.\n   * Corneal hypoesthesia (reduced corneal sensitivity)\n6. Keratoconus or an irregular cornea.\n7. Strabismus or amblyopia.\n8. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.",[82],"CHILD",[84,93,101,108,115,123,130,137,145,149,156,163,170,178,186,194,202,210,218,225,232,239,246,254,262,269,276,283,291,299],{"facility":85,"city":86,"state":87,"zip":88,"country":89,"geoPoint":90},"University of Alabama School of Optometry","Birmingham","Alabama","35233","United States",{"lat":91,"lon":92},33.52066,-86.80249,{"facility":94,"city":95,"state":96,"zip":97,"country":89,"geoPoint":98},"Marshall B. Ketchum University Southern California College of Optometry","Fullerton","California","92831",{"lat":99,"lon":100},33.87029,-117.92534,{"facility":102,"city":103,"state":96,"zip":104,"country":89,"geoPoint":105},"Vision Solutions Optometry Inc","La Mesa","91942",{"lat":106,"lon":107},32.76783,-117.02308,{"facility":109,"city":110,"state":96,"zip":111,"country":89,"geoPoint":112},"Paje Optometric","Santa Ana","92704",{"lat":113,"lon":114},33.74557,-117.86783,{"facility":116,"city":117,"state":118,"zip":119,"country":89,"geoPoint":120},"Coan Eye Care and Optical Boutique","Ocoee","Florida","34761",{"lat":121,"lon":122},28.56917,-81.54396,{"facility":124,"city":125,"state":118,"zip":126,"country":89,"geoPoint":127},"West Broward Eyecare Associates","Tamarac","33321",{"lat":128,"lon":129},26.21286,-80.24977,{"facility":131,"city":132,"state":118,"zip":133,"country":89,"geoPoint":134},"Bright Eyes Family Vision Care","Tampa","33626",{"lat":135,"lon":136},27.94752,-82.45843,{"facility":138,"city":139,"state":140,"zip":141,"country":89,"geoPoint":142},"SoLo Eye Care & Eyewear Gallery","Chicago","Illinois","60608",{"lat":143,"lon":144},41.85003,-87.65005,{"facility":146,"city":139,"state":140,"zip":147,"country":89,"geoPoint":148},"Illinois College of Optometry","60616",{"lat":143,"lon":144},{"facility":150,"city":151,"state":140,"zip":152,"country":89,"geoPoint":153},"Chicago College of Optometry","Downers Grove","60515",{"lat":154,"lon":155},41.80892,-88.01117,{"facility":157,"city":158,"state":140,"zip":159,"country":89,"geoPoint":160},"Carillon Vision Care","Glenview","60025",{"lat":161,"lon":162},42.06975,-87.78784,{"facility":164,"city":165,"state":140,"zip":166,"country":89,"geoPoint":167},"Brain Vision Institute","Schaumburg","60194",{"lat":168,"lon":169},42.03336,-88.08341,{"facility":171,"city":172,"state":173,"zip":174,"country":89,"geoPoint":175},"Clinical Optics Research Lab at IU School of Optometry","Bloomington","Indiana","47406",{"lat":176,"lon":177},39.16533,-86.52639,{"facility":179,"city":180,"state":181,"zip":182,"country":89,"geoPoint":183},"Kannarr Eye Care","Pittsburg","Kansas","66762",{"lat":184,"lon":185},37.41088,-94.70496,{"facility":187,"city":188,"state":189,"zip":190,"country":89,"geoPoint":191},"New England College of Optometry","Boston","Massachusetts","02115",{"lat":192,"lon":193},42.35843,-71.05977,{"facility":195,"city":196,"state":197,"zip":198,"country":89,"geoPoint":199},"Cornea and Contact Lens Institute","Edina","Minnesota","55436",{"lat":200,"lon":201},44.88969,-93.34995,{"facility":203,"city":204,"state":205,"zip":206,"country":89,"geoPoint":207},"Vision Source EyeCare","Kansas City","Missouri","64111",{"lat":208,"lon":209},39.09973,-94.57857,{"facility":211,"city":212,"state":213,"zip":214,"country":89,"geoPoint":215},"Athens Eye Care","Athens","Ohio","45701",{"lat":216,"lon":217},39.32924,-82.10126,{"facility":219,"city":220,"state":213,"zip":221,"country":89,"geoPoint":222},"Ohio State University","Columbus","43210",{"lat":223,"lon":224},39.96118,-82.99879,{"facility":226,"city":227,"state":213,"zip":228,"country":89,"geoPoint":229},"ProCare Vision Center, Inc.","Granville","43023",{"lat":230,"lon":231},40.06812,-82.5196,{"facility":233,"city":234,"state":213,"zip":235,"country":89,"geoPoint":236},"Miamisburg Vision Care","Miamisburg","45342",{"lat":237,"lon":238},39.64284,-84.28661,{"facility":240,"city":241,"state":213,"zip":242,"country":89,"geoPoint":243},"Eye Care Professionals","Powell","43065",{"lat":244,"lon":245},40.15784,-83.07519,{"facility":247,"city":248,"state":249,"zip":250,"country":89,"geoPoint":251},"Southern College of Optometry","Memphis","Tennessee","38104",{"lat":252,"lon":253},35.14953,-90.04898,{"facility":255,"city":256,"state":257,"zip":258,"country":89,"geoPoint":259},"Texas State Optical","Beaumont","Texas","77706",{"lat":260,"lon":261},30.08605,-94.10185,{"facility":263,"city":264,"state":257,"zip":265,"country":89,"geoPoint":266},"University of Houston College of Optometry","Houston","77204",{"lat":267,"lon":268},29.76328,-95.36327,{"facility":270,"city":271,"state":257,"zip":272,"country":89,"geoPoint":273},"Vision One Eyecare","Katy","77450",{"lat":274,"lon":275},29.78579,-95.8244,{"facility":277,"city":278,"state":257,"zip":279,"country":89,"geoPoint":280},"Lone Star Vision","Plano","75024",{"lat":281,"lon":282},33.01984,-96.69889,{"facility":284,"city":285,"state":286,"zip":287,"country":89,"geoPoint":288},"Utah Eye Centers","Ogden","Utah","84403",{"lat":289,"lon":290},41.223,-111.97383,{"facility":292,"city":293,"state":294,"zip":295,"country":89,"geoPoint":296},"Virginia Pediatric Eye Care","Chesapeake","Virginia","23320",{"lat":297,"lon":298},36.81904,-76.27494,{"facility":300,"city":301,"state":302,"zip":303,"country":89,"geoPoint":304},"Factoria Eye Clinic","Bellevue","Washington","98006",{"lat":305,"lon":306},47.61038,-122.20068,[],[309],{"name":310,"affiliation":311,"role":312},"Kathryn Richdale","CooperVision International Limited (CVIL)","STUDY_CHAIR",[],[],{"nct_id":4,"conditions":316,"biomarkers":317},[18],[],{"nct_id":4,"found":14,"summary":319,"prompt_version":329},{"design":320,"status":321,"heading":322,"summary":323,"follow_up":324,"word_count":325,"commitments":326,"compensation":327,"drugs_mentioned":328},"This is a randomized, controlled study where neither you nor the study staff will know which contact lens you are receiving (double-masked). It plans to include 900 participants.","completed","MiSight 1 Day Post-Approval Study for Myopia","This study is testing the MiSight 1 Day contact lens to see how well it slows down the worsening of myopia (nearsightedness) in children. It also looks at how stable these results are after treatment stops. You might be able to join if you are between 8 and 12 years old and have nearsightedness within a specific range. The study will compare MiSight 1 Day to another contact lens called Proclear 1 day. Researchers will measure changes in your eye's prescription and length over three years to see if MiSight 1 Day is effective. After that, all participants will wear Proclear 1 day for one year to see if the benefits last. The current recruitment status is unclear.","Participants will be followed for three years while wearing study lenses, and then for an additional year after switching to Proclear 1 day lenses.",118,"You would wear either MiSight 1 Day or Proclear 1 day contact lenses for three years, followed by one year of wearing Proclear 1 day lenses.","Not stated in the trial record.",[30,35],"v2"]