[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dompé Farmaceutici S.p.A\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":136},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,77,107],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100631684","phase-2-an-exploratory-efficacy-and-safety-study-of-dfl24498-topical-ophthalmic-solution-compared-with-vehicle-in-participants-with-dry-eye-disease-100631684",false,"NCT07503886","An Exploratory Efficacy and Safety Study of DFL24498 Topical Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease","A 12-Week, Phase 2, Multicenter, Randomized, Double-Masked, Vehicle Controlled, Parallel Group Study With 2 Weeks of Follow-Up to Evaluate the Efficacy and Safety of DFL24498 0.08% Topical Ophthalmic Solution Versus Vehicle in Participants With Dry Eye Disease","Key Inclusion Criteria:\n\n* A diagnosis of DED at least 6 months before enrollment (current use or recommended use of artificial tears for the treatment of dry eye).\n* The global score of the SANDE questionnaire ≥ 30\n* DED in at least one eye which is characterized by the following clinical features:\n\n  1. Schirmer I test without anesthesia \\\u003C 10 mm\u002F5 minutes, and\n  2. Total CFS grade ≥ 4 assessed by the NEI grading system, and\n  3. Fluorescein tear film break-up time (TFBUT) \\\u003C 10 seconds.\n* Best corrected visual acuity (BCVA) score on early treatment of diabetic retinopathy study (ETDRS) chart of ≥ 35 letters (corresponding to ≥ 0.1 Snellen decimal units or ≤ 1.0 Logarithm of the Minimum Angle of Resolution (Chart) \\[LogMAR\\]) in each eye at the time of study enrollment.\n* Only participants who satisfy all informed consent requirements will be included in the study.\n\nKey Exclusion Criteria:\n\n* Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.\n* Evidence of an active ocular infection in either eye.\n* Anticipated need for ocular surgery during the study period, or any prior ocular surgery for 6 months prior to screening.\n* Intraocular inflammation defined as anterior chamber cell or flare \\> 0 by Standardization of Uveitis Nomenclature (SUN) grading in either eye.\n* Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa) in either eye.\n\nNote: Additional protocol defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},417,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a Phase 2, randomized, multicenter, double masked, vehicle controlled, parallel group study to evaluate the efficacy and safety of DFL24498 topical ophthalmic solution versus vehicle in participants with dry eye disease. Approximately 417 participants aged 18 years or older who meet all eligibility criteria will be enrolled at study sites in the US. The study duration will be up to 16 weeks and will consist of three periods.",[26],"Dry Eye Disease (DED)",[28,29,30,31,32],"Dry Eye Disease","DFL24498","Ocular discomfort","Eye dryness","Topical ophthalmic solution","RECRUITING","2026-06-23",{"date":36,"type":37},"2026-06-26","ACTUAL",{"date":39,"type":37},"2026-05-12",{"date":41,"type":20},"2027-02-07",{"name":43,"class":44},"Dompé Farmaceutici S.p.A","INDUSTRY",24,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},"100627842","phase-3-efficacy-and-safety-of-intranasal-cenegermin-in-adult-participants-with-non-arteritic-anterior-ischemic-optic-neuropathy-naion-100627842","NCT07453888","Efficacy and Safety of Intranasal Cenegermin in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)","Randomized, Multicenter, Vehicle-Controlled, Double-Masked Phase 3 Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants With Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)","Key Inclusion Criteria:\n\n1. A clinical diagnosis of unilateral NAION in the study eye with symptom onset within 14 days prior to the planned date for first dose administration.\n2. A BCVA score in the study eye of ≥ 15 letters and ≤ 65 letters measured using the ETDRS chart.\n3. Sufficiently clear ocular media and adequate pupil dilation to enable assessment of the optic nerve and retina in both eyes.\n\nKey Exclusion Criteria:\n\n1. Bilateral NAION or sequential NAION with fellow eye involvement within 6 weeks of study eye involvement.\n2. Clinical evidence of temporal arteritis (giant cell arteritis) signs or symptoms.\n3. Abnormal laboratory findings suggestive of temporal arteritis (giant cell arteritis), in the absence of a known acute cause\n4. Pain with eye movement\n5. Intraocular pressure (IOP) greater than 25 mmHg in the study eye or history of glaucoma in the study eye.\n6. Intermediate age-related macular degeneration (AMD) with subfoveal drusen, exudative AMD, or geographic atrophy in the study eye.\n\nNote: Additional inclusion\u002Fexclusion criteria apply, as defined in the protocol.","50 Years","80 Years",{"count":56,"type":20},272,[58],"PHASE3","This is a phase 3, randomized, multicenter, vehicle-controlled, double-masked study to evaluate the efficacy and safety of intranasal cenegermin compared with vehicle control in adult participants with NAION. Approximately 272 participants who meet all eligibility criteria will be randomly assigned in a 1:1 ratio to receive either cenegermin treatment (Group 1) or the vehicle control (Group 2).",[61],"Non-Arteritic Anterior Ischemic Optic Neuropathy",[63,61,64,65,66,67],"Acute optic neuropathy","NAION","cenegermin","Optic neuropathy","Intranasal","2026-06-18",{"date":70,"type":37},"2026-06-22",{"date":72,"type":20},"2026-06-30",{"date":74,"type":20},"2027-09",{"name":43,"class":44},18,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":76},"100632916","phase-3-an-efficacy-and-safety-study-of-cenegermin-ophthalmic-solution-compared-with-vehicle-in-the-treatment-of-pced-100632916","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",{"count":85,"type":20},150,[58],"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).",[89],"Persistent Corneal Epithelial Defect",[91,92,93,94,95,96,97,98,89],"PCED","Recombinant Human Nerve Growth Factor","NGF","Ocular graft versus host disease","Neurotrophic keratitis","Vernal keratoconjunctivitis","Tropomyosin receptor kinase A","Low-affinity neurotrophic receptor","2026-06-04",{"date":101,"type":37},"2026-06-05",{"date":103,"type":37},"2026-06-02",{"date":105,"type":20},"2027-12",{"name":43,"class":44},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":118,"conditions":119,"keywords":121,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},"100623330","phase-3-an-efficacy-and-safety-study-of-dfl24498-in-the-treatment-of-akc-100623330","NCT07395232","An Efficacy and Safety Study of DFL24498 in the Treatment of AKC","A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Study to Demonstrate Efficacy and Safety of DFL24498 Eye Drop Solution in Adult Participants With Atopic Keratoconjunctivitis (AKC)","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Men or women aged ≥ 18 and ≤ 65 years of age.\n2. Diagnosis of AKC in both eyes, including the presence or medical history of the following:\n\n   1. other atopic condition (ie,. atopic dermatitis, periocular eczema, asthma, allergic rhinitis), AND\n   2. chronic allergic blepharoconjunctivitis and\u002For keratoconjunctivitis.\n3. Ocular itching of at least 50 as assessed by VAS scale.\n4. Corneal fluorescein staining assessed by modified Oxford scale of at least grade 1 AND a bulbar conjunctival hyperemia assessed by VBR 10 scale of at least 40 (range 0 to 100) in the same eye.\n5. A composite symptoms score (CSyS) ≥ 5 (sum of the severity scores graded 0 to 3 for each of the following: itching, tearing, ocular discomfort, photophobia, and mucous discharge score) (CSyS range of 0 to 15).\n6. If a woman of childbearing potential (WOCBP), must have a negative pregnancy test at both screening and baseline visit, and use an acceptable contraception method.\n\nExclusion Criteria:\n\nParticipants will be excluded if any of the following criteria apply:\n\n1. Inability to speak and understand the local language sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.\n2. Evidence of an active ocular infection in either eye.\n3. Intraocular inflammation defined as anterior chamber flare \\> 0 by Standardization of Uveitis Nomenclature (SUN) grading, in either eye.\n4. Known or suspected ocular malignancy (ocular surface, intraocular, ocular adnexa).\n5. Presence of cancer or any other systemic or unstable disease that may affect the ability to participate in the clinical study in the opinion of the investigator including basal cell carcinoma.\n6. Participants that are anatomically monocular.\n7. Systemic disease not stabilized within 1 month before the screening visit (eg, diabetes with glycemia out of range, thyroid malfunction) or judged by the investigator to be incompatible with the study (eg, current systemic infections) or with a condition incompatible with the frequent assessment required by the study.\n\nNote: Additional protocol defined Inclusion\u002FExclusion criteria apply","65 Years",{"count":116,"type":20},138,[58],"This is a phase 3, multicenter, randomized, double-masked, parallel-group, vehicle-controlled study to evaluate the safety and efficacy of DFL24498 compared with vehicle ophthalmic solution, in participants with AKC. Approximately 138 participants who meet all eligibility criteria will be enrolled in the study.",[120],"Atopic Keratoconjunctivitis",[122,120,29,123,124,125,126],"chronic, recurrent ocular surface inflammation,","Ophthalmic solution","Vehicle controlled","Eye drop solution","Corneal involvement","2026-04-16",{"date":129,"type":37},"2026-04-20",{"date":131,"type":37},"2025-12-01",{"date":133,"type":20},"2027-05",{"name":43,"class":44},19,""]