[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607175":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":22,"responsibleParty":29,"collaborators":22,"id":31,"slug":32,"hasResults":33,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":22,"eligibilityCriteria":37,"healthyVolunteers":33,"sex":38,"minAge":39,"maxAge":40,"enrollmentInfo":41,"targetDuration":22,"studyType":44,"phases":45,"briefSummary":47,"conditions":48,"keywords":22,"overallStatus":50,"whyStopped":22,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":22},{"fullName":5,"class":6},"Guangdong ProCapZoom Biosciences Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"MSCohi-O Lenses Group","EXPERIMENTAL","Each subject will wear MSCohi-O Lenses for 12 hours a day, totally 14-day wearings.",[13],"Drug: MSCohi-O Lenses",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","MSCohi-O Lenses","Each subject will wear MSCohi-O Lenses for 12 hours a day, totally 14 wearings.",[9],[21],"MSCohi-O",null,[24],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Jiexing Chen","CONTACT","18302002029","jxchen@procapzoom.com",{"type":30,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR","100607175","early-phase-1-mscohi-o-lenses-for-ocular-involvement-in-sjgrens-syndrome-100607175",false,"NCT07185139","MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome","Exploratory Clinical Trial of MSCohi-O Lenses for Ocular Involvement in Sjögren's Syndrome","Inclusion Criteria:\n\n* Aged 18-65 years old, including the boundary value, no gender restriction;\n* Subjects meeting the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.\n* Ocular signs and symptoms unresponsive to at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.\n* Extra-ocular manifestations of Sjögren's syndrome clinically stable.\n* Subjects and their partners agree to use effective non-pharmacological contraception from screening through 6 months after the last dose and have no plans for conception during this period.\n* Willing to participate in the study, understand and sign the informed consent form (ICF).\n\nExclusion Criteria:\n\n* Known allergy to any component of the investigational drug.\n* Active ocular infection.\n* Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.\n* History of any ocular surgery within the preceding 6 months, including cataract surgery.\n* Participation in another interventional clinical study.\n* Use of any ophthalmic medication that may interfere with the study outcomes, such as other stem-cell-derived products.\n* Having serious underlying diseases of the heart, brain vessels, liver, kidneys, and hematopoietic system.\n* Pregnant or lactating women; women of childbearing potential must employ an effective contraceptive method (e.g., intrauterine device, oral contraceptive, or condom) during the study and for at least 3 months after the final dose of study drug.\n* Subjects deemed unsuitable for participation in this trial by the investigator.","ALL","18 Years","65 Years",{"count":42,"type":43},12,"ESTIMATED","INTERVENTIONAL",[46],"EARLY_PHASE1","This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial.",[49],"Sjögren's Syndrome","NOT_YET_RECRUITING","2025-09-17",{"date":53,"type":54},"2025-09-22","ACTUAL",{"date":56,"type":43},"2025-09-12",{"date":58,"type":43},"2026-09-30",{"name":5,"class":6}]