[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100396298":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":43,"centralContacts":48,"locations":57,"responsibleParty":78,"collaborators":42,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":42,"eligibilityCriteria":86,"healthyVolunteers":83,"sex":87,"minAge":88,"maxAge":42,"enrollmentInfo":89,"targetDuration":42,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":59,"whyStopped":42,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Massachusetts Eye and Ear Infirmary","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"NAC 10% group","ACTIVE_COMPARATOR","Subjects in this group will be treated with eye drops containing a 10% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.",[13],"Drug: N-acetyl cysteine (NAC) 10% solution",{"label":15,"type":10,"description":16,"interventionNames":17},"NAC 20% group","Subjects in this group will be treated with eye drops containing a 20% solution of N-acetyl cysteine. Topical NAC is a well-tolerated medication that has many applications in ophthalmology including dry eye disease and meibomian gland dysfunction.",[18],"Drug: N-acetyl cysteine (NAC) 20% solution",{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo group","PLACEBO_COMPARATOR","Subjects in this group will be treated with a placebo (Visine Tears Dry Eye Relief artificial tears ophthalmic solution.)",[24],"Drug: Visine Dry Eye Relief eye drops",[26,33,38],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","N-acetyl cysteine (NAC) 10% solution","N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg\u002FmL) of acetylcysteine.",[9],[32],"acetylcysteine",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"N-acetyl cysteine (NAC) 20% solution","N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg\u002FmL) of acetylcysteine.",[15],[32],{"type":27,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Visine Dry Eye Relief eye drops","Visine Tears Dry Eye Relief artificial tears ophthalmic solution",[20],null,[44],{"name":45,"affiliation":46,"role":47},"Ula Jurkunas, MD","Mass Eye and Ear","PRINCIPAL_INVESTIGATOR",[49,54],{"name":50,"role":51,"phone":52,"phoneExt":42,"email":53},"Michael Cheung, MSc, CCRP","CONTACT","6175736060","mcheung0@meei.harvard.edu",{"name":45,"role":51,"phone":55,"phoneExt":42,"email":56},"617-573-4330","Ula_Jurkunas@meei.harvard.edu",[58],{"facility":5,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-71.05977,42.35843,{"lat":69,"lon":68},[72,74,77],{"name":45,"role":51,"phone":73,"phoneExt":42,"email":56},"6175734330",{"name":75,"role":51,"phone":52,"phoneExt":76,"email":53},"Michael Cheung, MSc. CCRP","Cheung",{"name":45,"role":47,"phone":42,"phoneExt":42,"email":42},{"type":47,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Ula Jurkunas","Associate Professor, Harvard Medical School","100396298","phase-2-targeting-reactive-oxygen-species-production-as-a-novel-therapeutic-in-fuchs-endothelial-corneal-dystrophy-100396298",false,"NCT04440280","Targeting Reactive Oxygen Species Production as a Novel Therapeutic in Fuch's Endothelial Corneal Dystrophy","Inclusion Criteria:\n\n1. Male or female ≥21 years of age at time of surgical evaluation.\n2. Diagnosis of advanced FECD and visually significant cataract\n3. Indication for DMEK (Descemet Membrane Endothelial Keratoplasty) with concurrent cataract surgery\n4. Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n5. Willingness and ability to adhere to medication regimen\n\nExclusion Criteria:\n\n1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.\n2. History of prior intraocular surgery in study eye including cataract, glaucoma and\u002For retina surgery\n3. History of other corneal diseases, such as severe dry eye, corneal scars, pseudophakic bullous keratopathy, corneal degenerations, corneal infections\n4. Use of ocular prescription medications except for lubricants, hyperosmotic agents, or ocular hypotensive agents\n5. History of ocular surface infection within the past 30 days\n6. Use of systemic, inhalational, or topical N-Acetylcysteine within the past 30 days\n7. History of intolerance to topical N-Acetylcysteine\n8. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.\n\n   \\-","ALL","21 Years",{"count":90,"type":91},45,"ESTIMATED","INTERVENTIONAL",[94],"PHASE2","This protocol will investigate whether topical application of N-acetyl cysteine (NAC) eye drops decreases oxidative stress and confers cytoprotection in patients with FECD.",[97],"Fuchs Endothelial Corneal Dystrophy",[99,97,100,101,102,103],"Fuchs","oxidative stress","N-Acetylcysteine ophthalmic drops","Descemet Membrane Endothelial Keratoplasty","DMEK","2025-09-23",{"date":106,"type":107},"2025-09-29","ACTUAL",{"date":109,"type":107},"2020-09-16",{"date":111,"type":91},"2027-04-30",{"name":5,"class":6},1]