[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633685":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":36,"locations":26,"responsibleParty":45,"collaborators":26,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":49,"sex":54,"minAge":55,"maxAge":26,"enrollmentInfo":56,"targetDuration":26,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":67,"whyStopped":26,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":26},{"fullName":5,"class":6},"Cellution Biologics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard of Care","ACTIVE_COMPARATOR","Beginning at the screening visit, participants will receive weekly treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage).",[13],"Other: Lyophilized Amnion Membrane Disc Allograft",{"label":15,"type":16,"description":17,"interventionNames":18},"FD-AM + SoC","EXPERIMENTAL","Participants with dye eye disease will receive treatment with a Freeze-Dried Amnionic Membrane product and treatment with standard of care (cleaning, application of Ofloxacin, topical anesthetic and bandage).",[19,13],"Procedure: Standard of Care (SOC)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Standard of Care (SOC)","Standard of care is to perform eye cleansing with sterile saline, application of one drop of Ofloxacin prophylactically to eye, application of topical anesthetic, application of bandage lens to eye, application of drops of saline as needed to ensure hydration, taping eye partially shut and continuation of preservative free topical lubricating drops.",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"OTHER","Lyophilized Amnion Membrane Disc Allograft","Lyophilized Amnion Membrane Disc Allograft derived from donated human tissues.",[15,9],[33],{"name":34,"affiliation":5,"role":35},"Research Director","STUDY_DIRECTOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":26,"email":41},"Bryanna Finstein","CONTACT","6035574660","bryanna.f@cellutionbiologics.com",{"name":43,"role":39,"phone":40,"phoneExt":26,"email":44},"Cellution Research","clinical@cellutionbiologics.com",{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100633685","phase-3-a-prospective-multicenter-randomized-controlled-trial-to-evaluate-the-efficacy-and-safety-of-amnion-membrane-disc-allograft-versus-standard-of-care-in-participants-with-moderate-to-severe-dry-eye-disease-100633685",false,"NCT07529899","A Prospective, Multicenter, Randomized Controlled Trial to Evaluate the Efficacy and Safety of Amnion Membrane Disc Allograft Versus Standard of Care in Participants With Moderate to Severe Dry Eye Disease","BLINK","Inclusion Criteria:\n\n1. 18 years of age or older.\n2. Corneal Fluorescein Staining (CFS) Modified NEI grade \\> 15 in the study eye.\n3. Distance best corrected visual acuity better than 20\u002F60 Snellen equivalent in each eye\n4. Participant failed at least one conservative therapy (artificial tears or topical lubrication) in the previous six months.\n5. Participant must be able to follow study instructions, with the intention of completing all required visits\n6. Participant must agree to attend the study visits required by the protocol.\n7. Participant must be able and willing to complete follow-up.\n8. Participant must be willing and able to participate in the informed consent process.\n\nExclusion Criteria:\n\n1. Presence of persistent corneal epithelial defect or ulcer in either eye\n2. Presence of active ocular infection in either eye\n3. Presence of ocular inflammation that is not related to keratoconjunctivitis sicca, e.g., allergy, severe blepharitis\n4. Presence of other corneal disorder(s) that give rise to reduced corneal sensitivity, such as recurrent herpes keratitis\n5. Presence of corneal diseases other than dry eye that can disturb the pre-corneal tear film such as epithelial basement membrane dystrophy (EBMD)\n6. Contact lens wear\n7. History of recent ocular surgery\u002Ftrauma, which could affect corneal sensitivity, e.g., corneal transplantation, LASIK\n8. Presence of cicatricial ocular surface diseases\n9. History of procedures listed in 6.7.1 within the specified washout period\n\n   CONFIDENTIAL\n\n   Version No. 1 Version Date 06APR2026\n\n   Page PAGE 67 of NUMPAGES 67\n\n   VERSION 1.0 CELLUTION BIOLOGICS INC. 06 APRIL 2026\n10. History or use of any medications listed in 6.7.2 within the specified washout period\n11. Ophthalmic use of amniotic membrane in the past 90 days.\n12. Participants of childbearing potential who are pregnant, considering becoming pregnant within the next 6 months, and\u002For are unwilling to utilize an appropriate form of contraception.\n13. Medical or psychological condition that, in the opinion of the investigator, may interfere with study.\n14. Sensitivity to ofloxacin, vancomycin, or amphotericin antibiotics.\n15. Participation in a clinical trial involving treatment with an investigational product within the previous 30 days.","ALL","18 Years",{"count":57,"type":58},40,"ESTIMATED","INTERVENTIONAL",[61],"PHASE3","To evaluate the efficacy of Lyophilized Human Amnion Membrane Disc in reducing corneal epithelial damage as measured by the Lexitas Modified National Eye Institute (NEI) Grading Scale for Corneal Fluorescein Staining.",[64],"Dry Eye Disease (DED)",[66],"Dry Eye","NOT_YET_RECRUITING","2026-04-08",{"date":70,"type":71},"2026-04-14","ACTUAL",{"date":73,"type":58},"2026-07",{"date":75,"type":58},"2026-12",{"name":5,"class":6}]