[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjogren-syndrome-with-keratoconjunctivitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjogren-syndrome-with-keratoconjunctivitis":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,71],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100644483","phase-2-safety-and-efficacy-of-topical-infliximab-in-autoimmune-dry-eye-disease-100644483",false,"NCT07671222","Safety and Efficacy of Topical Infliximab in Autoimmune Dry Eye Disease","Safety and Efficacy of Topical Infliximab Versus Topical Steroid in Autoimmune Dry Eye Disease: Randomized Controlled Trial.","INFLIXIDRY","Inclusion Criteria:\n\n* Adult patients (≥ 18 years).\n* Confirmed diagnosis of primary or secondary Sjögren's syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n* On stable systemic immunomodulatory therapy (non-biologic) for at least 12 weeks, with no planned changes during the study (see section 14.1 if there are concerns about confounding variables).\n* Negative chest X-ray or Interferon-Gamma Release Assays (IGRA).\n* Diagnosis of severe dry eye, defined by meeting all of the following criteria in at least one eye at study entry:\n* OSS (SICCA 0-12) ≥ 6 in at least one eye.\n* OSDI ≥ 33 (severe symptoms).\n* Symptoms: OSDI score ≥ 33.\n* Signs: Ocular Staining Score (OSS, SICCA) ≥ 6.\n* Ability to understand and sign informed consent and to comply with study procedures and treatment administration.\n\nExclusion Criteria:\n\n* Current use of topical corticosteroids or topical immunomodulators (cyclosporine, lifitegrast, tacrolimus, autologous serum) within 30 days prior to enrollment.\n* Current or recent use (\\\u003C 3 months) of punctal plugs.\n* Active ocular infection (bacterial, viral, fungal) or recent history of herpetic keratitis.\n* Ocular or eyelid surgery within the past 6 months.\n* Use of contact lenses during the study period.\n* Known allergy or hypersensitivity to infliximab, murine proteins, or any component of the formulation (including CMC).\n* Coexisting ocular conditions that may interfere with dry eye evaluation (e.g., active ocular cicatricial pemphigoid, active ocular graft-versus-host disease, uncontrolled glaucoma, significant corneal dystrophy).\n* Systemic conditions considered contraindications to infliximab exposure, including: active systemic infection, untreated active or latent tuberculosis, history of demyelinating disease, moderate to severe congestive heart failure (NYHA Class III\u002FIV), or history of malignancy within the past 5 years.\n* Use of systemic biologic agents within the past 6 months (12 months for systemic anti-TNF-α therapy).\n* Pregnancy, breastfeeding, or intention to become pregnant during the study.\n* Participation in another clinical trial with an investigational drug within the past 30 days.\n* Ability to understand and sign informed consent and to comply with study procedures and treatment administration.","ALL","18 Years",{"count":20,"type":21},38,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Sjögren's syndrome is a condition in which the immune system attacks the body's moisture-producing glands. This often causes severe dry eye, leading to discomfort, irritation, blurred vision, and damage to the eye surface. Inflammation plays an important role in this process, and a protein called TNF-alpha is one of the key drivers.\n\nThis study will test a new eye drop containing infliximab, a medication that blocks TNF-alpha. The goal is to see whether this treatment can safely improve symptoms and signs of severe dry eye in patients with Sjögren's syndrome.",[27,28,29],"Sjogren Syndrome","Sjogren Syndrome With Keratoconjunctivitis","Dry Eye Disease (DED)",[31,32,33,34],"Dry eye disease","Sjogren syndrome","Sjogren disease","Autoimmune dry eye","NOT_YET_RECRUITING","2026-06-22",{"date":38,"type":39},"2026-06-26","ACTUAL",{"date":41,"type":21},"2026-12",{"date":43,"type":21},"2028-03",{"name":45,"class":46},"Instituto de Oftalmología Fundación Conde de Valenciana","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":47},"100614258","phase-4-evaluating-a-new-therapy-for-dry-eye-in-patients-with-sjgrens-syndrome-100614258","NCT07277257","Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome","Evaluating TRYPTYR as a Novel Therapy for Dry Eye in Patients With Sjögren's Syndrome","Inclusion Criteria:\n\nSubjects must fulfill the following conditions to qualify for enrollment into the trial\n\n1. Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.\n2. History of using or desiring artificial tears for DED symptoms within the past 2 months.\n3. Unanesthetized Schirmer's Test (UA ST) score ≥1 and \\\u003C 10 mm\u002F5 min and baseline total Corneal Fluorescein Staining (tCFS) score ≥2 and ≤ 15 (National Eye Institute, NEI, grading scale).\n\nExclusion Criteria:\n\nSubjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.\n\n1. History of ocular surgery within the past 6 months.\n2. Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study\n3. On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.\n4. Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.\n5. Use of artificial tears within 2 hours prior to the baseline or study visit days.\n6. Any known allergies to any component of the study drug.\n7. Severe, uncontrolled autoimmune disease (e.g., rheumatoid arthritis, lupus). Uncontrolled is at the discretion of the PI. Subjects with severe systemic symptoms will not be included.",{"count":56,"type":21},35,[58],"PHASE4","This study will evaluate the effect of TRYPTYR in patients with Sjögren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population.",[28],"RECRUITING","2025-12-18",{"date":64,"type":39},"2025-12-22",{"date":66,"type":39},"2025-12-02",{"date":68,"type":21},"2026-12-31",{"name":70,"class":46},"Center For Sight",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":89,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":47},"100594024","phase-2-autologous-serum-obtained-by-a-closed-circuit-collection-device-100594024","NCT07014059","Autologous Serum Obtained by a Closed-Circuit Collection Device","\"In Vivo Evaluation of Topical Ocular Use of Autologous Serum Obtained by a Closed-Circuit Collection Device.\"","Inclusion Criteria:\n\n* ≥ 18 years\n* Dry eye and\u002For chronic epithelial defects of the ocular surface with indication for autologous serum according to the evaluation of ophthalmologists specialized in Cornea and Ocular Surface;\n* Peripheral venous access or PICC that allows the collection of whole blood.\n\nExclusion Criteria:\n\n* Active ocular infection;\n* Hemoglobin \\\u003C 11 g\u002FdL;\n* Angina, MI, or stroke in the last 30 days;\n* Significant pulmonary or cardiac disease that contraindicates autologous serum collection in the investigator's opinion;\n* Active ocular or systemic infection at the time of collection;\n* Inability to attend follow-up visits at 6 and 12 weeks;\n* Active hematological malignancy (except measurable residual disease) or solid malignancy (except non-melanoma skin cancer);\n* Positive for HIV, HCV, HBV, HTLV, Chagas disease, or syphilis;\n* Life expectancy \\\u003C 6 months;\n* Not pregnant (as reported by the participant).",{"count":79,"type":21},16,[24],"Autologous serum eye drops (ASED) are an established therapy for ocular surface diseases; however, their preparation can be costly and may not be available due to the need for germ-free conditions. This pilot trial assesses the feasibility of collecting ASED in a closed-circuit system for patients with chronic ocular surface diseases.",[83,84,85,86,87,88,28],"GVHD","Meibomian Gland Dysfunction (Disorder)","Stevens-Johnson Syndrome","Limbal Keratoconjunctivitis","Recurrent Erosions of Persistent Epithelial Defects","Neurotrophic Ulcer",[90,91,92,84,85,86,88,87,93,94],"soro autologo","gvhd","Sjogren's Syndrome (SS)","Study Protocol - Autologous Serum","Autologous Serum","2025-06-02",{"date":97,"type":39},"2025-06-10",{"date":99,"type":21},"2025-06-20",{"date":101,"type":21},"2027-06-20",{"name":103,"class":46},"GIANCARLO FATOBENE"]