[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585168":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":38,"responsibleParty":58,"collaborators":61,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":66,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"The University of New South Wales","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A - CsA 0.1% - Ikervis (CSL Seqirus, Parkville, Victoria) once daily at night-time + Cationorm","EXPERIMENTAL",null,[13,14],"Drug: 0.1% Ciclosporin A eye drops","Drug: Mineral oils eye drops",{"label":16,"type":17,"description":11,"interventionNames":18},"Group B - Cationorm (CSL Seqirus, Parkville, Victoria) four times daily in both eyes for 12-weeks.","ACTIVE_COMPARATOR",[14],[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","0.1% Ciclosporin A eye drops","The active intervention arm has CsA 0.1% - Ikervis (CSL Seqirus, Parkville, Victoria) and mineral oils lubricating eye drops - Cationorm (CSL Seqirus, Parkville, Victoria)",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Mineral oils eye drops","This arm is the comparator arm has mineral oils lubricating eye drops - Cationorm (CSL Seqirus, Parkville, Victoria)",[9,16],[30],{"name":31,"affiliation":5,"role":32},"Fiona Stapleton Professor, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":31,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","+61 0418868234","f.stapleton@unsw.edu.au",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"School of Optometry and Vision Science","RECRUITING","Sydney","New South Wales","2033","Australia","AU",{"type":48,"coordinates":49},"Point",[50,51],151.20732,-33.86785,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":11,"email":57},"Lisa Professor, PhD","+61 02 9385 4624","l.keay@unsw.edu.au",{"type":32,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Soumen Sadhu","Coordinating Investigator",[62],{"name":63,"class":6},"University of Melbourne","100585168","the-effect-of-01-topical-ciclosporin-a-for-12-weeks-on-the-eye-surface-immune-cells-in-dry-eyes-100585168",false,"NCT06898853","The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes","The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Ocular Surface Innate and Adaptive Immune Response in Dry Eye Disease","Inclusion Criteria:\n\n1. 18 years of age and above\n2. Participants should meet any two of the following DED diagnostic criteria: i) ocular surface disease index score of ≥23 and ii) Oxford staining score of ≥1 iii) Tear meniscus height \\\u003C 0.2 mm.\n\nExclusion Criteria:\n\n1. Participants currently using or with previous use of steroids, ciclosporin, lifitegrast or any anti-inflammatory eye drops in the last 6 months.\n2. Participants with systemic CsA or tacrolimus\n3. Known hypersensitivity or contraindication to the study medication or any of its ingredients.\n4. Active intraocular inflammation.\n5. Contact lens wear or the use of contact lenses in the last 4 weeks.\n6. Active eye infections or history of critical illness.\n7. DED secondary to Steven-Johnson syndrome and cicatricial conjunctival disease.\n8. Participants with other ocular co-morbidities and medications for glaucoma.\n9. Participants with previous history of ocular surgery in the past 6 months.\n10. Any other active or inactive systemic condition, structural abnormality such as eyelid malposition's that in the judgment of the investigator could confound study assessments or limit compliance.\n11. Pregnant\u002Fbreastfeeding women","ALL","18 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","Dry eye disease (DED) is a common, long-lasting condition that affects the surface of the eye. It happens when there's a problem with tear production or quality, which can lead to inflammation and discomfort. The immune system plays a big role in how DED develops and continues.\n\nResearchers have found that in people with DED, there are more immune cells and inflammatory substances in the tears and on the eye's surface. This includes various types of immune cells, like T cells and dendritic cells, which are part of the body's defense system.\n\nThe first treatment for DED is usually artificial tears, but because the condition is chronic and can flare up, clinicians often use anti-inflammatory treatments too. One such treatment is cyclosporine A (CsA), which comes as eye drops. CsA works by reducing inflammation and affects how immune cells behave.\n\nResearchers can study the immune cells on the eye's surface using a special microscopy technique called in vivo confocal microscopy (IVCM). A newer version of this method, called functional IVCM (Fun-IVCM), allows researchers to watch how these cells move and behave over time.\n\nIn the current study, researchers want to compare 0.1% CsA with a lubricating eye drop to see how they affect the immune cells on the eye's surface. The researchers will use Fun-IVCM to look at the number, shape, and movement of immune cells of the eye. The researchers will also collect samples from the eye's surface and tears to measure various markers of inflammation.\n\nThe goal is to better understand how CsA works in treating DED by directly observing its effects on the immune response in the eye, which is unexplored. This could help improve treatments for people suffering from this condition and expand the use of CsA in DED.",[81],"Dry Eye Disease (DED)","2026-04-28",{"date":84,"type":85},"2026-05-05","ACTUAL",{"date":87,"type":85},"2025-06-01",{"date":89,"type":75},"2026-12-30",{"name":5,"class":6},1]