[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644483":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":44,"responsibleParty":57,"collaborators":32,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":32,"enrollmentInfo":70,"targetDuration":32,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":86,"whyStopped":32,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Instituto de Oftalmología Fundación Conde de Valenciana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Infliximab group","EXPERIMENTAL","Arm A: Infliximab Group (Intervention)\n\nParticipants assigned to this group will receive:\n\nTopical infliximab 1 mg\u002FmL (0.1%) in CMC 1%, one drop in each eye four times daily (QID) Topical corticosteroid (loteprednol 0.5%), one drop in each eye QID (standard therapy) This group evaluates whether adding infliximab to standard therapy improves symptoms and ocular surface inflammation.",[13],"Drug: Infliximab 0.1%",{"label":15,"type":16,"description":17,"interventionNames":18},"Vehicle group","ACTIVE_COMPARATOR","Participants assigned to this group will receive:\n\nVehicle (CMC 1%) eye drops without infliximab, one drop in each eye four times daily (QID) Topical corticosteroid (loteprednol 0.5%), one drop in each eye QID (standard therapy) Preservative-free artificial tears as needed (rescue treatment) This group serves as the control, allowing comparison against standard treatment plus vehicle.",[19],"Drug: Loteprednol",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Infliximab 0.1%","It uses topical infliximab at 1 mg\u002FmL (0.1%) formulated in preservative-free 1% carboxymethylcellulose (CMC), administered as 1 drop in each eye four times daily for 6 weeks. The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.",[9],[27],"Infliximab",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Loteprednol","The comparator is an identical vehicle (CMC 1% without infliximab), which helps isolate the effect of infliximab itself.",[15],null,[34],{"name":35,"affiliation":36,"role":37},"Enrique Graue-Hernandez, MD, MSc","Instituto de Oftalmologia Fundacion Conde de Valenciana","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Gustavo Ortiz-Morales, MD","CONTACT","5554421700","dr.gortizmor@gmail.com",[45],{"facility":46,"status":32,"city":47,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":32},"Instituto de Oftalmología Conde de Valenciana","Mexico City","06800","Mexico","MX",{"type":52,"coordinates":53},"Point",[54,55],-99.12766,19.42847,{"lat":55,"lon":54},{"type":37,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Nicolas Kahuam Lopez","Consultant Cornea and Refractive Surgery Department","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":71,"type":72},38,"ESTIMATED","INTERVENTIONAL",[75],"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.",[78,79,80],"Sjogren Syndrome","Sjogren Syndrome With Keratoconjunctivitis","Dry Eye Disease (DED)",[82,83,84,85],"Dry eye disease","Sjogren syndrome","Sjogren disease","Autoimmune dry eye","NOT_YET_RECRUITING","2026-06-22",{"date":89,"type":90},"2026-06-26","ACTUAL",{"date":92,"type":72},"2026-12",{"date":94,"type":72},"2028-03",{"name":5,"class":6},1]