[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653467":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":21,"studyPopulation":21,"armGroups":39,"interventions":52,"overallOfficials":60,"centralContacts":64,"locations":70,"responsibleParty":183,"collaborators":21,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":21,"eligibilityCriteria":190,"healthyVolunteers":191,"sex":192,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":21,"studyType":198,"phases":199,"briefSummary":201,"conditions":202,"keywords":21,"overallStatus":87,"whyStopped":21,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},{"fullName":5,"class":6},"Johnson & Johnson Vision Care, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":23,"otherOutcomes":21},[9,13,16,19],{"measure":10,"description":11,"timeFrame":12},"Mean binocular HLHC distance Visual Acuity","Mean binocular HLHC VA at distance (4m)","At 1-week follow-up",{"measure":14,"description":15,"timeFrame":12},"Mean binocular HLHC Intermediate Visual Acuity","Mean binocular HLHC VA at Intermediate (64cm)",{"measure":17,"description":18,"timeFrame":12},"Mean binocular HLHC Near Visual Acuity","Mean binocular HLHC VA at Near (40cm)",{"measure":20,"description":21,"timeFrame":22},"Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events.",null,"Up to 1-month follow-up",[24,26,27,28],{"measure":10,"description":11,"timeFrame":25},"At 1-month follow-up",{"measure":14,"description":15,"timeFrame":25},{"measure":17,"description":18,"timeFrame":25},{"measure":29,"description":30,"timeFrame":22},"Incidence rate of Slit Lamp Findings (SLF)","Slit lamp findings will be assessed for each eye at all study visits (scheduled and unscheduled) by grade. SLFs will be evaluated and graded using the ISO 11980 Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e., Grade 1 = trace, Grade 2 = mild, Grade 3 = moderate and Grade 4 = severe).",{"allocation":32,"interventionModel":33,"interventionModelDescription":21,"primaryPurpose":34,"observationalModel":21,"timePerspective":21,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":21,"whoMasked":37},"SINGLE",[38],"PARTICIPANT",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Senofilcon A","EXPERIMENTAL","Eligible subjects will be randomized to the Senofilcon A Lens for the duration of the study.",[45],"Device: Senofilcon A",{"label":47,"type":48,"description":49,"interventionNames":50},"Nelfilcon A","ACTIVE_COMPARATOR","Eligible subjects will be randomized to the Nelfilcon A Lens for the duration of the study.",[51],"Device: Nelfilcon A",[53,57],{"type":54,"name":41,"description":55,"armGroupLabels":56,"otherNames":21},"DEVICE","ACUVUE® Oasys MAX 1-Day Multifocal",[41],{"type":54,"name":47,"description":58,"armGroupLabels":59,"otherNames":21},"DAILIES® AquaComfort Plus® Multifocal",[47],[61],{"name":62,"affiliation":5,"role":63},"Johnson & Johnson Vision Care, Inc. Clinical Trial","STUDY_DIRECTOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":21,"email":69},"Study Contact","CONTACT","1-800-843-2020","tkarkkai@its.jnj.com",[71,85,96,106,116,125,134,144,154,164,173],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":21},"Pearson Research Center PA","ACTIVE_NOT_RECRUITING","Longwood","Florida","32779","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-81.3384,28.70305,{"lat":83,"lon":82},{"facility":86,"status":87,"city":88,"state":89,"zip":90,"country":77,"countryCode":78,"cosmosGeoPoint":91,"geoPoint":95,"contacts":21},"VisualEyes","RECRUITING","Roswell","Georgia","30076",{"type":80,"coordinates":92},[93,94],-84.36159,34.02316,{"lat":94,"lon":93},{"facility":97,"status":87,"city":98,"state":99,"zip":100,"country":77,"countryCode":78,"cosmosGeoPoint":101,"geoPoint":105,"contacts":21},"The Koetting Associates","St Louis","Missouri","63144",{"type":80,"coordinates":102},[103,104],-90.19789,38.62727,{"lat":104,"lon":103},{"facility":107,"status":87,"city":108,"state":109,"zip":110,"country":77,"countryCode":78,"cosmosGeoPoint":111,"geoPoint":115,"contacts":21},"Spectrum Eyecare","Jamestown","New York","14701",{"type":80,"coordinates":112},[113,114],-79.23533,42.097,{"lat":114,"lon":113},{"facility":117,"status":87,"city":118,"state":109,"zip":119,"country":77,"countryCode":78,"cosmosGeoPoint":120,"geoPoint":124,"contacts":21},"Center for Ophthalmic and Vision Research\u002FEye Associates of New York","Manhattan","10022",{"type":80,"coordinates":121},[122,123],-73.96625,40.78343,{"lat":123,"lon":122},{"facility":126,"status":87,"city":127,"state":109,"zip":128,"country":77,"countryCode":78,"cosmosGeoPoint":129,"geoPoint":133,"contacts":21},"Sacco Eye Group","Vestal","13850",{"type":80,"coordinates":130},[131,132],-76.05381,42.08507,{"lat":132,"lon":131},{"facility":135,"status":87,"city":136,"state":137,"zip":138,"country":77,"countryCode":78,"cosmosGeoPoint":139,"geoPoint":143,"contacts":21},"Dr. David W. Ferris & Associates","Warwick","Rhode Island","02888",{"type":80,"coordinates":140},[141,142],-71.41617,41.7001,{"lat":142,"lon":141},{"facility":145,"status":87,"city":146,"state":147,"zip":148,"country":77,"countryCode":78,"cosmosGeoPoint":149,"geoPoint":153,"contacts":21},"Total Eye Care","Memphis","Tennessee","38119",{"type":80,"coordinates":150},[151,152],-90.04898,35.14953,{"lat":152,"lon":151},{"facility":155,"status":87,"city":156,"state":157,"zip":158,"country":77,"countryCode":78,"cosmosGeoPoint":159,"geoPoint":163,"contacts":21},"Paradigm Research Center, LLC","Houston","Texas","77030",{"type":80,"coordinates":160},[161,162],-95.36327,29.76328,{"lat":162,"lon":161},{"facility":165,"status":87,"city":166,"state":157,"zip":167,"country":77,"countryCode":78,"cosmosGeoPoint":168,"geoPoint":172,"contacts":21},"Tyler Eye Associates","Tyler","75703",{"type":80,"coordinates":169},[170,171],-95.30106,32.35126,{"lat":171,"lon":170},{"facility":174,"status":87,"city":175,"state":176,"zip":177,"country":77,"countryCode":78,"cosmosGeoPoint":178,"geoPoint":182,"contacts":21},"Botetourt Eyecare, LLC","Salem","Virginia","24153",{"type":80,"coordinates":179},[180,181],-80.05476,37.29347,{"lat":181,"lon":180},{"type":184,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100653467","comparison-of-acuvue-oasys-max-1-day-multifocal-and-dailies-aquacomfort-plus-multifocal-100653467",false,"NCT07788521","Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal","Potential subjects must satisfy all of the following criteria to be enrolled in the study:\n\n1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.\n2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.\n3. Be at least 40 years of age and not greater than 70 years of age at the time of consent.\n4. Own a wearable pair of spectacles if required for their distance vision.\n5. Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 30 days or more duration).\n6. Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the \"Presbyopic Symptoms Questionnaire\".\n7. The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.50 D to -5.50 D in each eye.\n8. The subject's refractive cylinder must be ≤0.75 D in each eye.\n9. The subject's ADD power must be in the range of +0.75 D to +2.50 D.\n10. The subject must have distance best corrected visual acuity of 0.0 logMAR (20\u002F20 Snellen, 5.0 on the China standard 5-point logMAR visual acuity scale) or better in each eye.\n\nPotential subjects who meet any of the following criteria will be excluded from participating in the study:\n\n1. Be currently pregnant or lactating.\n2. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.\n3. Have been diagnosed with diabetes.\n4. Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).\n5. Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy\u002Firidectomy, cataract surgery, retinal surgery, etc.).\n6. Have a history of amblyopia, strabismus or binocular vision abnormality.\n7. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral\u002Finhaled corticosteroids.\n8. Use of any ocular medication.\n9. Have a history of herpetic keratitis.\n10. Have a history of irregular cornea.\n11. Have a history of pathological dry eye.\n12. Have a history of glaucoma or glaucoma suspect.\n13. Have a history of any retinal disease\u002Fcondition that may interfere with any of the study assessments or are not stable and have potential to progress during the study.\n14. Have participated in any contact lens or lens care product clinical trial within 15 days prior to study enrollment.\n15. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild, sibling of the employee or their spouse) of the clinical site.\n16. Have any known hypersensitivity or allergic reaction to sodium fluorescein.\n17. Have Grade 3 or greater palpebral conjunctival observations or Grade 2 or greater slit lamp findings (e.g. corneal edema, corneal vascularization, corneal staining, bulbar injection, etc.) on the ISO 11980 classification scale, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.\n18. Have any current ocular infection or inflammation.\n19. Have intraocular pressure in one or both eyes \\>21mmHg\n20. Have signs of any retinal disease\u002Fconditions that may interfere with any of the study assessments or are not stable and have potential to progress during the study.",true,"ALL","40 Years","70 Years",{"count":196,"type":197},150,"ESTIMATED","INTERVENTIONAL",[200],"NA","This study is a 4-visit, multi-site, prospective, controlled, randomized, single-masked (subjects), two-arm parallel group, bilateral, dispensing clinical trial to compare the performance of the Test lens to the Control lens in terms of safety and efficacy.",[203],"Visual Acuity","2026-09-24",{"date":206,"type":207},"2026-09-29","ACTUAL",{"date":209,"type":207},"2026-09-10",{"date":211,"type":197},"2026-12-11",{"name":5,"class":6},11]