[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556504":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":30,"responsibleParty":41,"collaborators":44,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":56,"minAge":57,"maxAge":20,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":70,"overallStatus":73,"whyStopped":20,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"The University of Hong Kong","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Participants with iTEAR100 Neurostimulator","EXPERIMENTAL","The participants will use iTEAR100 Neurostimulator for the stimulation of the anterior ethmoidal nerve - which is located at the point between bony and fleshy tissue alongside the nose. Participants should apply stimulation to each side of the nose for 30 seconds, twice a day. It is recommended to apply once in the morning and once in the evening.",[13],"Device: iTEAR100 Neurostimulator",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","iTEAR100 Neurostimulator","To apply an iTEAR100 Neurostimulator for the stimulation to the anterior ethmoidal nerve - which is located at the point between bony and fleshy tissue alongside the nose. Participants should apply stimulation to each side of the nose for 30 seconds, twice a day. It is recommended to apply once in the morning and once in the evening.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Allie LEE, Dr.","PRINCIPAL_INVESTIGATOR",[26],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","(852) 3962 1405","aleeni@hku.hk",[31],{"facility":32,"status":20,"city":33,"state":20,"zip":20,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":20},"Department of Ophthalmology, LKS Faculty of Medicine, The University of Hong Kong","Hong Kong","HK",{"type":36,"coordinates":37},"Point",[38,39],114.17469,22.27832,{"lat":39,"lon":38},{"type":24,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Allie Lee","Clinical Assistant Professor",[45],{"name":46,"class":47},"ARCTIC VISION HONG KONG BIOTECH LIMITED","UNKNOWN","100556504","phase-4-itear-single-center-open-label-single-arm-study-100556504",false,"NCT06525961","iTear Single-center, Open-label, Single-arm Study","A Single-center, Open-label, Single-arm Study to Evaluate the Effectiveness and Safety of Extra Nasal Neurostimulator in Patients With Dry Eye Disease Dissatisfied With Artificial Tears","Inclusion Criteria:\n\nEach patient must meet all the following criteria to be enrolled in this study:\n\n1. Provided informed consent, approved by the Institutional Review Board (IRB), to participate in the study.\n2. Reported use of artificial tears for DED within 30 days of Visit 1.\n3. Ocular Surface Disease Index (OSDI) ≥ 23 (with no more than 3 N\u002FA in the answers).\n4. Anesthetized Schirmer Test Score ≤ 10 mm\u002F5 min in at least one eye.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from the study:\n\n1. Used extranasal or intranasal neurostimulator within 30 days of Visit 1.\n2. Participation in any clinical trial with an investigational drug or device within 30 days of Visit 1.\n3. In the opinion of the investigator, any condition that could impair study participation\u002Focular evaluation or the potential risks of participation outweigh the potential benefits.",true,"ALL","18 Years",{"count":59,"type":60},30,"ESTIMATED","INTERVENTIONAL",[63],"PHASE4","This study aims to evaluate the effectiveness and safety of a device, iTEAR100 Neurostimulator (the device), which is designed to help people with Dry Eye Disease (DED) who are not satisfied with using artificial tears. The study will last three months and take place at one location. Thirty participants will use the iTEAR100 Neurostimulator, which stimulates the outside of the nose to help with dry eye symptoms.\n\nParticipants will have three main visits: one at the start (Day 0), one after 30 days (Day 30), and one at the end of the study (Day 90). For the first 30 days, they will use the device twice a day for 30 seconds on each side of the nose. After that, they will use it as needed for the next 60 days.\n\nBefore starting the treatment, participants will undergo tests to measure their initial eye condition. The effectiveness of the device will be checked by comparing these baseline measurements to those taken on Day 30 and Day 90. Participants will also fill out a questionnaire about their eye symptoms on Day 14.\n\nThe main measure of success is how much the participants' symptoms improve on the Ocular Surface Disease Index (OSDI) from Day 0 to Day 30. Other measures include changes in tear production, tear quality, and eye health from Day 0 to Days 30 and 90. Participants' safety will be monitored by tracking any adverse events (side effects) throughout the study.",[66,67,68,69],"Dry Eye Disease","Dry Eye Syndromes","Dry Eye","Meibomian Gland Dysfunction",[68,71,67,72],"DED","Meibomian Gland Dysfunction (MGD)","NOT_YET_RECRUITING","2024-07-23",{"date":76,"type":77},"2024-07-29","ACTUAL",{"date":79,"type":60},"2024-08",{"date":81,"type":60},"2026-01",{"name":5,"class":6},1]