[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617714":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":28,"responsibleParty":66,"collaborators":20,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":20,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":20,"enrollmentInfo":76,"targetDuration":20,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":20,"overallStatus":31,"whyStopped":20,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Unicon Optical Co. Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Open-label, single-arm, dispensing study.","EXPERIMENTAL","Qualis (linofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens",[13],"Device: Treatment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Treatment","Test lenses will be worn on a daily disposable basis for up to 13 weeks. Subjects will be instructed to wear the test lenses at least 6 hours a day, a minimum of 5 days per week.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":26,"email":27},"Nick Liao","CONTACT","+886-3-5775586","1307","ra@uniconvision.com.tw",[29,50],{"facility":30,"status":31,"city":32,"state":20,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Kaohsiung Medical University Chung-Ho Memorial Hospital","RECRUITING","Kaohsiung City","807","Taiwan","TW",{"type":37,"coordinates":38},"Point",[39,40],120.31333,22.61626,{"lat":40,"lon":39},[43,47],{"name":44,"role":24,"phone":45,"phoneExt":20,"email":46},"Hsu Doctor","886-7-3121101","shiuhlianghsu@gmail.com",{"name":48,"role":49,"phone":20,"phoneExt":20,"email":20},"Hsu SL","PRINCIPAL_INVESTIGATOR",{"facility":51,"status":31,"city":52,"state":20,"zip":53,"country":34,"countryCode":35,"cosmosGeoPoint":54,"geoPoint":58,"contacts":59},"Linkou Chang Gung Memorial Hospital","Taoyuan","333",{"type":37,"coordinates":55},[56,57],121.29696,24.99368,{"lat":57,"lon":56},[60,64],{"name":61,"role":24,"phone":62,"phoneExt":20,"email":63},"Hwang Doctor","+886-3-3281200","yihshiou.hwang@gmail.com",{"name":65,"role":49,"phone":20,"phoneExt":20,"email":20},"Hwang YS",{"type":67,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100617714","a-study-to-evaluate-the-clinical-performance-and-safety-of-unicon-silicone-hydrogel-daily-disposable-soft-contact-lenses-100617714",false,"NCT07322211","A Study to Evaluate the Clinical Performance and Safety of UNICON Silicone Hydrogel Daily Disposable Soft Contact Lenses","Inclusion Criteria:\n\n1. Adult with an age ≥ 18;\n2. Be a currently adapted soft contact lens wearer who successful wear of soft contact lenses in both eyes for a minimum of 5 days per week and 6 hours per day within 3 months prior to study screening (by verbal confirmation);\n3. Participant must be stop wearing any contact lenses more than 7 days prior to screening;\n4. Able to wear contact lenses within a range of power from -2.00D to -6.00D (0.25 D steps) in both eyes;\n5. Astigmatism of 1.25D or less in both eyes;\n6. Be correctable to a visual acuity of 1.0 decimal (0.0 logMAR) or better in each eye;\n7. Participant must be able to be successfully fit with study lenses;\n8. The participant must appear able and willing to adhere to the instructions set forth in this clinical protocol;\n9. The participant must read and sign the Informed Consent Form.\n\nExclusion Criteria:\n\n1. Women who are currently pregnant;\n2. Women who are lactating or planning a pregnancy at the time of enrollment (by verbal confirmation at the screening visit);\n3. Any use of systemic or ocular medications (e.g., non-steroidal anti-inflammatory eye drops, ophthalmic steroids) within 30 days prior to study enrollment for which contact lens wear could be contraindicated, as determined by the investigator;\n4. Any current or history ocular or systemic disease which may interfere with contact lens wear, as determined by the investigator;\n5. Any current or previous orthokeratology treatment within 90 days prior to study enrollment, or planned for orthokeratology treatment during the study;\n6. Any previous history of ocular and\u002For refractive surgery (e.g., radial keratotomy, PRK, LASIK, etc.) or planned for ocular and\u002For refractive surgery during the study;\n7. Current or history of herpetic keratitis in either eye;\n8. Current or history of intolerance, hypersensitivity or allergy to silicone hydrogel soft contact lenses or any component of the study products;\n9. Current clinical finding of entropion, ectropion, chalazia, recurrent styes, glaucoma, pathologically dry eye (defined as Schirmer test \\\u003C 5 mm\u002F5 min), recurrent corneal erosions, aphakia, or moderate or above corneal distortion;\n10. Employee of Department of Ophthalmology and clinic (e.g., Investigator, Coordinator, Technician);\n11. Participation in any interventional clinical trial within 30 days prior to study enrollment;\n12. Any biomicroscopy findings at screening that are Grade 3 or higher and\u002For corneal neovascularization that is Grade 2 or higher and\u002For presence of corneal infiltrates;\n13. Any history of a contact lens-related corneal inflammatory or infectious event within 12 months prior to study enrollment that may contraindicate contact lens wear;\n14. Any anterior segment infection, inflammation, or abnormality or disease (including systemic) that contraindicates contact lens wear, as determined by the investigator;\n15. Participants are considered ineligible for the study as judged by the investigator.","ALL","18 Days",{"count":77,"type":78},35,"ESTIMATED","INTERVENTIONAL",[81],"NA","13 weeks, open-label, daily disposable contact lens dispensing study.",[84],"Refractive Ametropia","2026-01-20",{"date":87,"type":88},"2026-01-22","ACTUAL",{"date":85,"type":88},{"date":91,"type":78},"2026-10-31",{"name":5,"class":6},2]