[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"persistent-corneal-epithelial-defect\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:persistent-corneal-epithelial-defect":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,79,108],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100632916","phase-3-an-efficacy-and-safety-study-of-cenegermin-ophthalmic-solution-compared-with-vehicle-in-the-treatment-of-pced-100632916",false,"NCT07519902","An Efficacy and Safety Study of Cenegermin Ophthalmic Solution Compared With Vehicle in the Treatment of PCED","Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Recombinant Human Nerve Growth Factor Eye Drop Solution in Participants With Persistent Corneal Epithelial Defect (PCED)","Inclusion Criteria:\n\n* Men or women aged 18 years or above (in South Korea, 19 years or above).\n* Participants with PCED in the study eye with the following characteristics:\n\n  1. PCED ≥ 1.0 mm in greatest diameter\n  2. PCED of at least 14 days duration, refractory to 1 or more conventional nonsurgical treatments (ocular lubricants, discontinuation of preserved topical drops and medications, bandage contact lens) showing no clinical resolution.\n* Use of most topical ophthalmic medications (including glaucoma medications) indicated for ocular conditions other than PCED is permitted in the study eye, if the participant has been on a stable dose for at least 30 days and does not expect to have change in dosing regimen throughout the entire duration of the study. Please see exclusion criteria list for exceptions.\n* Use of prophylactic topical antibiotics up to 4 times per day in the study eye is permitted if the participant is already receiving them prior to enrollment.\n\nExclusion Criteria:\n\n* Contralateral eye with vision of no light perception or anatomic absence of contralateral eye.\n* Active ocular infection or inflammation in the study eye as follows:\n\n  1. Bacterial, fungal, or protozoal infection at screening\n  2. Active infectious stromal infiltrates or edema at screening\n  3. Acute anterior uveitis of grade 2 or greater within 30 days of screening\n  4. Acute intermediate uveitis or posterior uveitis within 30 days of screening\n  5. Acute inflammation of the sclera or conjunctiva if it is not associated with the PCED\n* Corneal epithelial defect associated with stromal thinning greater than 30% (estimated on clinical slit lamp exam) or if associated with stromal infiltrate (corneal haze is acceptable), in the study eye.\n* Severe eyelid disease in the study eye, such as:\n\n  1. Mechanical eyelid abnormalities that have direct contact with the PCED (e.g., trichiasis, severe entropion with lid margin keratinization, etc, if in direct contact with the PCED)\n  2. Lagophthalmos greater than 2 mm as measured in the clinic\n  3. Existing diagnosis of nocturnal lagophthalmos or Parkinson's disease\n  4. Inability to fully close eyelids despite voluntary eyelid closure\n  5. Severe ectropion with abnormal eyelid-globe congruity (e.g., the lower eyelid does not come into contact with the globe due to severe ectropion)\n* Severe end-stage ocular surface disease in the study eye, including but not limited to:\n\n  1. Severe limbal stem cell deficiency, defined as involvement of more than 270 cumulative degrees or more of limbal stem cell deficiency\n  2. Keratinization of the bulbar conjunctiva or lid margin\n* Use of the following medications and devices within the indicated time window prior to randomization:\n\n  a. Local medications in study eye:\n* Any prior use of cenegermin\n* Blood-derived eye drops (autologous serum) or other ocular surface re-epithelizing agents, topical anesthetic use by the participant outside of the clinical exam setting, topical insulin, or topical steroids (unless associated with post-operative treatment regimen) within 7 days\n* Botox (botulinum toxin) injections for pharmacologic tarsorrhaphy within 90 days b. Systemic medications:\n* High-dose systemic corticosteroids (greater than 0.5 mg\u002Fkg\u002Fday) within 30 days\n* Any changes in oral medication regimen intended for the treatment of the ocular surface (eg, oral doxycycline) within 30 days, or planned changes during the study period\n* Systemic opioid use within 30 days\n* Use of any systemic investigational product, ocular investigational product in the study eye, radiation of the head or neck, or systemic chemotherapy within 90 days, or planned to occur during the study period c. Devices:\n* Use of contact lens (including therapeutic contact lens) within 7 days, or planned use of contact lens during the study period, in the study eye\n* Anticipated need for punctal occlusion in the study eye during the study period. Participants with punctal occlusion or punctal plugs inserted prior to the study are eligible for enrolment provided that the punctual occlusion is maintained throughout the study.\n* Presence of acute severe systemic disease as follows:\n\n  1. Any acute or active severe systemic inflammatory disease (eg, acute systemic Stevens-Johnson Syndrome, acute systemic GVHD, severe systemic Sjogren's, mucous membrane pemphigoid)\n  2. Presence of any systemic disease that may affect ability to participate in the clinical study according to the clinical judgment of the investigator\n* Recent surgery or amniotic membrane therapy as follows:\n\n  1. Recent major surgical procedure for the treatment of PCED (eg, conjunctival flap, complete tarsorrhaphy, superficial keratectomy for epithelial defect revision, etc) within 14 days of randomization\n  2. Presence of amniotic membrane from AMT for ocular surface indication if not dissolved within area of PCED within 14 days of randomization. Examples include:\n* Sutured AMT\n* Self-retaining AMT\n* Contact lens combined with AMT\n* Other AMT treatment for the ocular surface c. Partial tarsorrhaphy (temporary or permanent) placed within 14 days of randomization. If a participant is enrolled with partial tarsorrhaphy placed more than 14 days prior to randomization, then the tarsorrhaphy must not be removed for the entire duration of the study.\n\nNote: Additional exclusion criteria apply, as defined in the protocol","ALL","18 Years",{"count":19,"type":20},150,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a phase 3, randomized, multicenter, double-masked, parallel group, vehicle-controlled prospective clinical trial to evaluate the safety and efficacy of cenegermin in inducing complete epithelial healing in participants with PCED. The primary objective is the evaluation of complete epithelial healing after 4 weeks of treatment. The study is comprised of 3 periods: an 8-week initial treatment period (Day 1 to Week 8), an 8-week extension treatment period (Week 9 to Week 16), and a 24-week follow-up period (Week 17 to Week 40).",[26],"Persistent Corneal Epithelial Defect",[28,29,30,31,32,33,34,35,26],"PCED","Recombinant Human Nerve Growth Factor","NGF","Ocular graft versus host disease","Neurotrophic keratitis","Vernal keratoconjunctivitis","Tropomyosin receptor kinase A","Low-affinity neurotrophic receptor","RECRUITING","2026-06-04",{"date":39,"type":40},"2026-06-05","ACTUAL",{"date":42,"type":40},"2026-06-02",{"date":44,"type":20},"2027-12",{"name":46,"class":47},"Dompé Farmaceutici S.p.A","INDUSTRY",18,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100636108","phase-4-comparison-of-topical-insulin-and-amniotic-membrane-transplant-for-persistent-corneal-epithelial-defects-100636108","NCT07561398","Comparison of Topical Insulin and Amniotic Membrane Transplant for Persistent Corneal Epithelial Defects","Comparison of Efficacy of Topical Insulin With Amniotic Membrane Transplant in Persistent Epithelial Defects of Cornea","Inclusion Criteria:\n\n* Corneal epithelial defects for more than 2 weeks no improvement using standard treatment\n\nExclusion Criteria:\n\n* • Systemic conditions e.g. uncontrolled Diabetes, autoimmune disorders\n\n  * Recent eye surgery within last 3 months\n  * Hereditary corneal dystrophies\n  * Active eye infections",true,"16 Years","70 Years",{"count":60,"type":20},214,[62],"PHASE4","After an initial period of standard treatment, they received further care aimed at helping the surface of the eye heal. Clear instructions were given on how to use and store the treatment properly. Patients were then monitored regularly over several months, with doctors checking their healing progress during follow-up visits. The study continued for a total of 24 weeks to observe how well and how quickly the eye surface recovered.",[26],[66,67],"Topical Insulin","Amniotic Membrane graft","2026-04-28",{"date":70,"type":40},"2026-05-01",{"date":72,"type":40},"2026-03-27",{"date":74,"type":20},"2026-09-27",{"name":76,"class":77},"Al-Shifa Trust Eye Hospital","OTHER",1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":78},"100586723","phase-2-efficacy-of-topical-mesenchymal-stromal-cell-secretome-for-ocular-surface-disease-100586723","NCT06919081","Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease","Phase II Study of the Efficacy of Topical Mesenchymal Stromal Cell Secretome for Ocular Surface Disease","Inclusion Criteria:\n\n* Age · Patients 18 years of age or older\n* Ocular Health\n\n  * Chronic corneal epithelial disease with fluorescein staining score 6 by NEI grading scale or persistent corneal epithelial defect present for longer than 14 days despite standard treatment\n  * No objective clinical evidence of significant (\\> 50%) improvement\u002Fworsening of the epithelial disease in the last 14 days\n  * Epithelial disease refractory to conventional non-surgical treatments (e.g., preservative-free artificial tears, gels or ointments; discontinuation of preserved topical drops; anti-inflammatory therapy)\n  * If both eyes of subject meet the inclusion criteria, the eye with the higher fluorescein staining score will be enrolled to the study.\n* Study Procedures\n\n  * Only patients who satisfy all Informed Consent requirements may be included in the study. The patient and\u002For his\u002Fher legal representative must read, sign and date the Informed Consent document before any study-related procedures are performed. The Informed Consent form signed by patients and\u002For legal representative must have been approved by the UIC IRB for the current study. Patients must have the ability and willingness to comply with study procedures.\n\nExclusion Criteria:\n\n* Ocular Health\n\n  * Any active or suspected ocular infection (bacterial, viral, fungal or protozoal).\n  * History of any ocular surgery (including laser or refractive surgical procedures) in the study eye within the 3 months prior to study enrollment.\n  * Treatment with Oxervate in the study eye within 12 months of enrollment.\n* Study Procedures\n\n  * Known hypersensitivity to one of the components of the study or procedural medications (e.g., fluorescein).\n  * Use of any investigational agent within 4 weeks of screening visit.\n  * Participation in another clinical study at the same time as the present study.\n  * Participants who are pregnant at the time of study enrollment.",{"count":87,"type":20},24,[89],"PHASE2","In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease\u002Fdefect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.",[26,92],"Corneal Epithelial Disorders",[94,95,96,97,98],"persistent corneal epithelial disease\u002Fdefects","persistent corneal epithelial","corneal epithelial disease","limbal stem cell deficiency","neurotrophic keratitis","2026-01-27",{"date":101,"type":40},"2026-01-29",{"date":103,"type":40},"2025-08-01",{"date":105,"type":20},"2026-06-15",{"name":107,"class":77},"University of Illinois at Chicago",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":16,"minAge":116,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100513517","phase-2-a-study-to-evaluate-the-safety-and-efficacy-of-nexagon-lufepirsen-ophthalmic-gel-in-subjects-with-pced-100513517","NCT05966493","A Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With PCED","A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of NEXAGON® (Lufepirsen Ophthalmic Gel) in Subjects With Persistent Corneal Epithelial Defects (NEXPEDE-1)","NEXPEDE-1","Inclusion Criteria:\n\n1. Have a PCED that is at least 2 weeks in duration and refractory to one or more conventional non-surgical standard of care (SOC) treatments\n2. Have no clinical evidence of improvement in the PCED within 2 weeks prior to randomization despite the use of non-surgical SOC treatment\n3. Subject must provide written informed consent (or assent)\n4. Subjects with childbearing potential must be 1-year postmenopausal, surgically sterilized, or have a negative urine pregnancy test\n\nExclusion Criteria:\n\n1. Have a known ocular infection that is deemed to be active requiring therapeutic intervention\n2. Present with a corneal surface defect in either eye that is directly attributed to an infectious etiology (bacterial, viral, fungal and\u002For protozoal) that has not fully resolved and\u002For treatment has not been completed\n3. Present with evidence of corneal ulceration\u002Fmelting involving the posterior third of the stroma and\u002For perforation in either eye\n4. Have a blepharitis or meibomian gland disease in the study eye that is deemed to be clinically relevant and\u002For active\n5. Have a history of ocular surgery or any ocular procedure(s) not meeting the designated washout time\n6. Have any other ocular disease requiring topical ocular medication in the affected eye\n7. Have a presence or history of any ocular or systemic disorder or condition that could interfere the safety or efficacy of the study treatment, or the interpretation of the study results\n8. Have a known hypersensitivity to one of the components of the study or procedural medications (e.g., NEXAGON, fluorescein)\n9. Participated in an interventional clinical drug or device trial within 28 days prior to Day 1\n10. Use of the medications presented in the protocol that are prohibited in the study.","2 Years",{"count":118,"type":20},84,[89],"This study is to evaluate the safety and efficacy of NEXAGON® (lufepirsen ophthalmic gel) (NEXAGON) in subjects with persistent corneal epithelial defects (PCED). The objectives of the study are to evaluate the safety and efficacy of NEXAGON in this population.",[26],[28,123,124],"Corneal Defect","PED","2025-07-21",{"date":127,"type":40},"2025-07-24",{"date":129,"type":40},"2023-08-17",{"date":131,"type":20},"2025-12",{"name":133,"class":47},"Glaukos Corporation",28]