[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611779":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":31,"centralContacts":40,"locations":46,"responsibleParty":61,"collaborators":31,"id":63,"slug":31,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":31,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":31,"enrollmentInfo":71,"targetDuration":31,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":31,"overallStatus":48,"whyStopped":31,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Eye & ENT Hospital of Fudan University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo Group","PLACEBO_COMPARATOR","Placebo ophthalmic solution",[13],"Drug: Placebo Ophthalmic Solution (Vehicle)",{"label":15,"type":16,"description":17,"interventionNames":18},"Low-Dose JN002 Group","EXPERIMENTAL","JN002 Ophthalmic Solution at a concentration of 0.05 mg\u002FmL",[19],"Drug: JN002 Ophthalmic Solution (0.05 mg\u002FmL)",{"label":21,"type":16,"description":22,"interventionNames":23},"High-Dose JN002 Group","JN002 Ophthalmic Solution at a concentration of 0.1 mg\u002FmL",[24],"Drug: JN002 Ophthalmic Solution (0.1 mg\u002FmL)",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Placebo Ophthalmic Solution (Vehicle)","Placebo ophthalmic solution (vehicle without active ingredient JN002), administered three times daily (1 drop per eye per dose) for 28 ± 2 consecutive days",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"JN002 Ophthalmic Solution (0.05 mg\u002FmL)","JN002 Ophthalmic Solution at a concentration of 0.05 mg\u002FmL, administered three times daily (1 drop per eye per dose) for 28 ± 2 consecutive days",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"JN002 Ophthalmic Solution (0.1 mg\u002FmL)","JN002 Ophthalmic Solution at a concentration of 0.1 mg\u002FmL, administered three times daily (1 drop per eye per dose) for 28 ± 2 consecutive days",[21],[41],{"name":42,"role":43,"phone":44,"phoneExt":31,"email":45},"Jiaxu Hong","CONTACT","021-64377134","Jiaxu.hong@fdeent.org",[47],{"facility":5,"status":48,"city":49,"state":31,"zip":31,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Shanghai","China","CN",{"type":53,"coordinates":54},"Point",[55,56],121.45806,31.22222,{"lat":56,"lon":55},[59],{"name":42,"role":43,"phone":60,"phoneExt":31,"email":45},"86 21 64377134",{"type":62,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100611779",false,"NCT07245017","JN002 for the Treatment of Dry Eye Disease","Randomized, Double-Blind, Placebo-Controlled, Single Center Clinical Trial to Evaluate the Safety and Preliminary Efficacy of JN002 Ophthalmic Solution in Adult Patients With Dry Eye Disease","Inclusion Criteria:\n\n1. Aged 18 years or older\n2. Ocular Surface Disease Index (OSDI) score ≥ 13\n3. Schirmer I test result ≤ 10 mm\u002F5 min\n4. Fluorescein tear film break-up time \\\u003C 10 seconds\n5. Corneal Fluorescein Staining score (National Eye Institute grading) ≥ 4\n6. Best corrected visual acuity ≥ 0.6\n7. Intraocular pressure ≤ 21 mmHg\n8. Voluntarily agrees to participate in the study\n\nExclusion Criteria:\n\n1. History of refractive surgery or intraocular surgery within the past 6 months\n2. Clinically relevant ocular abnormalities at screening or baseline, including but not restricted to eye trauma, pterygium, allergic keratoconjunctivitis, active ocular infections, or abnormal ocular structures\n3. Uncontrolled ocular or systemic diseases\n4. Other conditions deemed by the investigators likely to interfere with study parameters\n5. Females with plans for pregnancy at enrollment or during the treatment period","ALL","18 Years",{"count":72,"type":73},30,"ESTIMATED","INTERVENTIONAL",[76],"EARLY_PHASE1","This is a first-in-human, single-center, randomized, double-blind, placebo-controlled clinical trial designed to:·Evaluate the efficacy of JN002 Ophthalmic Solution in treating dry eye disease (DED)·Assess the safety of JN002 Ophthalmic SolutionResearchers will compare three groups-placebo (vehicle), low-dose JN002 (0.05 mg\u002FmL), and high-dose JN002 (0.1 mg\u002FmL)-to evaluate whether JN002 Ophthalmic Solution improves DED outcomes and to assess its safety profile relative to placebo.Participants will:·Complete a baseline assessment (V0) including ocular exams, OSDI questionnaire, and systemic evaluation;·Administer the assigned study medication three times daily (1 drop per eye per administration);·Attend three follow-up visits (V1: 7±2 days, V2: 14±2 days, V3: 28±2 days post-treatment initiation) for ocular assessments, symptom queries, and adherence checks;·Undergo a full repeat of baseline assessments at V3 to evaluate treatment effects and safety profile",[79],"Dry Eye","2025-11-28",{"date":82,"type":83},"2025-12-01","ACTUAL",{"date":85,"type":83},"2025-11-24",{"date":87,"type":73},"2026-03",{"name":5,"class":6},1]