[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neurotrophic-keratitis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neurotrophic-keratitis":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,42,68,95,125,155],{"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100636672","phase-2-a-multicenter-randomized-vehicle-controlled-double-masked-to-open-label-study-to-evaluate-the-safety-and-efficacy-of-lacripep-in-subjects-with-neurotrophic-keratitis-100636672",false,"NCT07568730","A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep in Subjects With Neurotrophic Keratitis","A Multicenter, Randomized, Vehicle-Controlled, Double-Masked to Open-Label Study to Evaluate the Safety and Efficacy of Lacripep 4 μM Ophthalmic Solution in Subjects With Neurotrophic Keratitis","Inclusion Criteria:\n\nSubjects who meet all the following inclusion criteria at Visit 1 (Screening) will be eligible to participate in the study.\n\n1. Are ≥18 years of age.\n2. Provide informed consent before any study-related procedures are performed.\n3. Are willing and able to comply with study procedures and the study schedule.\n4. Female subjects must either be incapable of pregnancy or must use an effective method of birth control for the duration of the study. Female subjects of childbearing potential must have a negative pregnancy test and not be nursing.\n5. Have all of the following in at least one eye:\n\n   1. Stage 1 NK as defined by:\n\n      * Grade 3 cCFS using the National Eye Institute (NEI) scale (0-3 in one-point increments).\n      * Corneal sensitivity ≤4 cm in the central zone, as measured by Cochet-Bonnet aesthesiometer.\n   2. BCDVA +0.2 to +1.0 logarithm of the minimum angle of resolution (logMAR) (Snellen equivalent 20\u002F32 to 20\u002F200).\n   3. IOP ≤21 mmHg.\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria at Visit 1 (Screening) will not be eligible to participate in the study. Ocular criteria apply to each eye independently, unless otherwise noted.\n\n1. Have received prior treatment with Lacripep Ophthalmic Solution or Oxervate® (cenegermin-bkbj) Ophthalmic Solution within 6 months prior to Visit 1 (Screening) and failed to demonstrate a clinically meaningful response, as determined by the Investigator.\n2. Have participated in a NK study within 90 days prior to Visit 1 (Screening).\n3. Have participated in any other clinical study or used an investigational agent within 30 days prior to Screening or plans to participate in another clinical study at any time during the conduct of this study.\n4. Have a glycated hemoglobin (HbA1c) score \\>9% within 90 days prior to Visit 1 (Screening).\n5. Have a history of or current conditions that may confound the study data; such conditions include but are not limited to ocular cicatricial pemphigoid, graft versus host disease, neuromyelitis optica, Stevens-Johnson syndrome, and Salzmann's nodular degeneration.\n6. Have an unstable history of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the study period) or chronic conjunctivitis and\u002For keratitis other than dry eye disease.\n7. Have been diagnosed with glaucoma or are a glaucoma suspect who requires or may require treatment during the study.\n8. Have, in the opinion of the Investigator, evidence of an active ocular infection (bacterial, viral, protozoal) in either eye.\n9. Have any intraocular inflammation (Tyndall score \\>0).\n10. Have, in the opinion of the Investigator, severe vision loss due to retinal disease, with no potential for visual improvement.\n11. Have an eyelid abnormality that may alter eyelid function; such abnormalities include but are not limited to blepharospasm, cerebrovascular accident, entropion, ectropion, and floppy lid syndrome.\n12. Have punctal occlusion or punctal plugs that will not be maintained during the study period.\n13. Have had any corneal surface procedure within 90 days prior to Visit 1 (Screening). This includes laser-assisted in situ keratomileusis (LASIK), phototherapeutic or photorefractive keratectomy (PTK or PRK), radial keratotomy (RK), small-incision lenticule extraction (SMILE), penetrating keratoplasty (PK), automated lamellar keratoplasty (ALK), deep anterior lamellar keratoplasty (DALK), Descemet membrane endothelial keratoplasty (DMEK), Descemet stripping endothelial keratoplasty (DSEK), superior limbic keratoconjunctivitis (SLK) surgery, and placement of any amniotic membrane.\n14. Have, in the opinion of the Investigator, NK that was induced by a neurosurgical procedure.\n15. Have undergone any other ocular surgery (including peripheral iridotomy (PI), laser iridotomy (LI) eyelid surgery and any surgical refractive procedures) within 90 days prior to Visit 1 (Screening) or expect to undergo ocular surgery during the study period.\n16. Have, in the opinion of the Investigator, history of viral corneal disease that resulted in significant corneal scarring.\n17. Have viral corneal disease without scarring that is considered unstable prior to Visit 1 (Screening), defined as discontinuation of topical ocular antiviral therapy or topical ocular steroid therapy within 2 weeks prior to Screening, or evidence of viral reactivation during the run-in period.\n18. Have received Botox (botulinum toxin) ocular injections to induce pharmacologic blepharoptosis within 45 days prior to Visit 1 (Screening).\n19. Have used any non-study issued eye drops or neurostimulators within 14 days prior to Visit 2 (Day 1; Baseline\u002FRandomization).\n20. Anticipate a need to use therapeutic contact lenses or unwilling to discontinue wearing contact lenses for refractive correction during the study period.\n21. Have, in the opinion of the Investigator, an unstable medical condition that may confound the study data; such conditions include but are not limited to diabetes, thyroid disease, autoimmune disease, Parkinson's disease, and multiple sclerosis.\n22. Evidence of current drug or alcohol abuse or addiction, in the opinion of the Investigator.\n23. Are pregnant, nursing, or planning a pregnancy during the study period.\n24. Are an employee of a site directly involved in the management, administration, or support of the study or an immediate family member of the same.","ALL","18 Years",{"count":19,"type":20},54,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Objective: To evaluate the safety of Lacripep 4 μM Ophthalmic Solution and its effect on the ocular surface, visual function, corneal sensitivity, and quality of life of subjects with Stage 1 NK.",[26],"Neurotrophic Keratitis",[26,28],"NK","RECRUITING","2026-05-07",{"date":32,"type":33},"2026-05-11","ACTUAL",{"date":35,"type":33},"2026-02-19",{"date":37,"type":20},"2027-03",{"name":39,"class":40},"TearSolutions, Inc.","INDUSTRY",3,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":53,"conditions":54,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100591078","phase-2-a-phase-ii-study-of-stsp-0902-ophthalmic-solution-in-patients-with-neurotrophic-keratitis-100591078","NCT06975748","A Phase II Study of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis","A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of STSP-0902 Ophthalmic Solution in Patients With Neurotrophic Keratitis","Inclusion Criteria:\n\n1. Male or female patients aged between 18 to 85 years (inclusive).\n2. Diagnosed with NK in one or both eyes, with the study eye classified as Mackie Stage 2 (PED) or Stage 3 (corneal ulcer), and with a maximum corneal defect diameter ≥2 mm.\n3. Reduced or absent corneal sensitivity in the defect area and at least 1 adjacent corneal quadrant, confirmed by: ≤40 mm using the aesthesiometer or cotton swab test demonstrating marked reduction or absence of corneal sensitivity.\n4. NK duration \\>2 weeks in the study eye, as confirmed by the investigator based on medical history.\n5. No improvement in the study eye for ≥7 days prior to randomization.\n6. Effective non-pharmacological contraception used by the subject (and partner, if applicable) throughout the trial and for 3 months after the last dose, with no plans for pregnancy or gamete donation.\n7. Voluntarily sign informed consent, with willingness and ability to comply with study procedures, follow-ups, and assessments.\n\nExclusion Criteria:\n\n1. Any eye with corneal stromal ulceration involving \\>1\u002F3 of corneal thickness or at risk of corneal melting\u002Fperforation.\n2. Active infection (bacterial, viral, fungal, amoebic, chlamydial) in any eye, or active ocular inflammation unrelated to NK.\n3. Study eye with other ocular diseases requiring topical medication apart from the prescribed adjunctive treatments during the trial.\n4. Bilateral vision loss severely impacting daily life, as assessed by the investigator.\n5. Study eye with Schirmer I test ≤3 mm\u002F5 minutes.\n6. Severe lagophthalmos, eyelid margin disease, or meibomian gland dysfunction in the study eye that may impair corneal healing or trial outcomes.\n7. Study eye with any surgery within 3 months prior to randomization (including corneal\u002Fnon-corneal surgeries affecting trial assessments, except surgeries related to NK etiology), or planned ocular surgery during the trial.\n8. Study eye with prior surgical intervention for NK (e.g., tarsorrhaphy, conjunctival flap) that may confound efficacy assessments, or amniotic membrane transplantation within 6 weeks prior to randomization.\n9. Study eye with botulinum toxin injections to the levator muscle within 3 months prior to randomization or planned during the trial.\n10. Requirement to wear contact lenses during the trial.\n11. History of inefficacy or poor response to nerve growth factor (NGF) eye drops in any eye.\n12. Use of autologous serum eye drops, deproteinized calf blood extracts, or other growth factor-containing ocular medications in the study eye(s) planned during the trial.\n13. Use of NSAIDs, or corticosteroids in the study eye within 1 week prior to randomization or planned during the trial.\n14. Use of neurotoxic drugs (e.g., antipsychotics, antiepileptics, antihistamines) or systemic immunosuppressants within 4 weeks prior to randomization or planned during the trial, excluding those who have been using it stably for at least 4 weeks before enrollment.\n15. Poorly controlled systemic or ocular conditions (e.g., diabetic retinopathy, uveitis, autoimmune diseases, malignancies, psychiatric disorders) that may confound efficacy assessments or compliance, as judged by the investigator.\n16. Known hypersensitivity to the study drug, its excipients, or components of trial-related ophthalmic tests (e.g., fluorescein).\n17. History of drug abuse or alcohol dependence.\n18. Participation in another interventional trial (drugs, devices, or vaccines) within 3 months prior to randomization or planned during this trial.\n19. Female subjects who are pregnant, breastfeeding, or test positive for serum pregnancy; or who are failure to use effective contraception for 2 weeks prior to screening, during the trial, or for 3 months post-dosing.\n20. Difficulty administering eye drops, venous blood sampling, or history of needle phobia\u002Fvasovagal syncope.\n21. Any other condition deemed unsuitable for trial participation by the investigator.","85 Years",{"count":51,"type":20},48,[23],"This is a Phase II, double-blind, placebo-controlled study to evaluate the safety and efficacy of STSP-0902 ophthalmic solution in patients with neurotrophic keratitis (NK). The study plans to enroll 48 patients with Mackie Stage 2 or 3 NK affecting one or both eyes. Eligible subjects will be randomized 1:1:1 into three dosing groups. Each dosing group will follow a drug-placebo allocation (12 active: 4 placebo). Treatment involves topical ocular administration for 8 weeks. Subjects who are not healed after the 8 weeks of masked treatment period will be permitted to receive standard of care during the follow-up period",[26],[56,57,26],"STSP-0902","Ophthalmic Solution","2026-04-01",{"date":60,"type":33},"2026-04-07",{"date":62,"type":33},"2025-06-12",{"date":64,"type":20},"2026-04",{"name":66,"class":40},"Staidson (Beijing) Biopharmaceuticals Co., Ltd",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100592922","phase-1-a-study-comparing-kb801-verse-placebo-in-patients-with-stage-2-or-3-neurotrophic-keratitis-100592922","NCT06999733","A Study Comparing KB801 Verse Placebo in Patients With Stage 2 or 3 Neurotrophic Keratitis","A Phase 1\u002F2, Multicenter, Double-Masked, Placebo-Controlled Study of KB801 in Subjects With Stage 2 or 3 Neurotrophic Keratitis","EMERALD-1","Inclusion Criteria:\n\n1. The subject must have read, understood, and signed an Institutional Review Board (IRB) approved Informed Consent Form and must be willing and able to comply with study procedures and instructions.\n2. Aged ≥ 18 years at the time of informed consent.\n3. Diagnosis of Stage 2 or Stage 3 NK, as defined by the Mackie criteria.\n4. Persistent corneal epithelial defect (PCED) between Screening 1 and Screening 2 without clinical improvement during that time. PCED is defined as a focal loss of the cornea's outermost cell layer and can include involvement of the deeper stromal layers (i.e., corneal ulcer).\n5. PCED at Screening 1 must have a minimum of 1 mm of any linear measurement of defect.\n6. A negative pregnancy test at Screening 1 and Day 1 for women of child-bearing potential.\n\nExclusion Criteria:\n\n1. An active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK in the study eye as assessed by Investigator at Screening 1 or 2.\n2. Use of any prohibited therapies at Screening or anticipated need for topical treatments other than the investigational product or products allowed per protocol in the study eye from Screening through the study Treatment Period\n\n   a. Sufficient washout of prohibited therapies must occur prior to meeting eligibility criteria.\n3. Anticipated use of therapeutic contact lenses or contact lens wear for refractive correction during the study Treatment Period in the study eye.\n4. Evidence of corneal ulceration involving the posterior third of the corneal stroma, corneal melting, descemetocele, impending or perforation in the study eye at the time of Screening 1 or 2.\n5. PCED at Screening 1 or 2 of \\> 8 mm maximum linear measurement in any eye.\n6. The central 3 mm of corneas contain PCED bilaterally at Screening 1 or 2.\n7. Anticipated need for punctal occlusion of the study eye during the Treatment Period.\n8. Presence or history of any ocular or systemic disorder or condition that might hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the Investigator to be incompatible with the study visit schedule or conduct (e.g., progressive or degenerative corneal or retinal conditions, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases).\n9. Participation in another clinical study or treatment with an investigational agent 30 days or 5 half-lives, whichever is longer, prior to Day 1 (participation in a non-interventional observational study is permitted).\n10. Intraocular surgery on the eligible eye(s) within 6 months prior to Screening 1, and any ophthalmic condition that may require surgery on the study eye during the Treatment Period. An exception to the preceding statement is allowed if, in the opinion of the Investigator, the ocular surgery is deemed the cause of the NK.\n11. Corneal transplantation (i.e., keratoplasty) of the study eye within the past 2 years or a history of multiple keratoplasty operations to the study eye regardless of timing. This includes full- or partial-thickness, or endothelial keratoplasty.\n12. Subject who is pregnant or nursing.\n13. Subject who is unwilling to comply with contraception requirements per-protocol (for subjects of childbearing potential).\n14. Subject who is known to be noncompliant or is unlikely to comply with the requirements of the study protocol, in the opinion of the Investigator.",{"count":77,"type":20},60,[79,23],"PHASE1","The Sponsor is developing KB801, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human nerve growth factor (NGF) to the corneas of people with Stage 2 or 3 neurotrophic keratitis (NK) via topical application. This is a Phase 1\u002F2, multicenter, double-masked, placebo-controlled study to evaluate the safety, tolerability, and preliminary efficacy of KB801 in these subjects.",[26],[26,83,84],"Persistent Corneal Epithelial Defect","Corneal Epithelial Defect","2026-02-25",{"date":87,"type":33},"2026-02-27",{"date":89,"type":33},"2025-07-07",{"date":91,"type":20},"2027-12",{"name":93,"class":40},"Krystal Biotech, Inc.",9,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":21,"phases":105,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":67},"100598610","corneal-neurotization-vs-cenergermin-for-neurotrophic-keratitis-a-pilot-study-100598610","NCT07073729","Corneal Neurotization vs. Cenergermin for Neurotrophic Keratitis: A Pilot Study","Corneal Neurotization: A Study on the Outcomes of Nerve Repair for Corneal Sensory Dysfunction","Inclusion Criteria:\n\n* Adults aged 19 years and older.\n* Diagnosis of neurotrophic keratitis with reduced or absent corneal sensation.\n* Clinical indication for either corneal neurotization surgery or topical Cenergermin treatment, as determined by the treating ophthalmologist.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Active ocular infection or inflammation.\n* Previous corneal neurotization procedure in the affected eye.\n* Contraindications to general anesthesia or surgical intervention.\n* Participation in another interventional clinical trial within the past 3 months.","19 Years",{"count":104,"type":20},10,[106],"NA","This pilot study evaluates the feasibility and outcomes of two treatment approaches for corneal sensory dysfunction due to neurotrophic keratitis (NK): corneal neurotization surgery and topical Cenergermin (Oxervate). Participants will receive treatment based on clinical decision-making, not randomization, and will be followed for 12 months through eight visits at the Ivey Eye Institute, St. Joseph's Health Care London. Data collected during routine eye examinations and validated quality-of-life questionnaires will be used to assess visual outcomes, corneal structure and function, and patient-reported well-being. This feasibility study is funded by the Lawson Research Institute Internal Research Fund and is intended to generate preliminary evidence for a future randomized trial.",[26],[110,111,112,113],"Corneal Neurotization","Cenergermin","Neurotrophic Keratopathy","Corneal Sensory Dysfunction","NOT_YET_RECRUITING","2025-07-09",{"date":117,"type":33},"2025-07-18",{"date":119,"type":20},"2025-08-01",{"date":121,"type":20},"2027-08-01",{"name":123,"class":124},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":138,"conditions":139,"keywords":142,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":153,"locationsCount":67},"100590196","phase-4-use-of-acthar-gel-single-dose-pre-filled-selfjecttm-injector-in-patients-with-moderate-severe-keratitis-and-autoimmune-disease-100590196","NCT06964269","Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease","A Phase 4 Pilot Study With Extension to Assess the Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease and the Effect on Corneal Nerves and Neuropathic Corneal Pain","MNK","Inclusion Criteria:\n\n1. Subject can read, understand, sign and informed consent.\n2. Provision of signed and dated informed consent form and HIPPA authorization.\n3. Stated willingness to comply with all study procedures and availability\n4. for the duration of the study\n5. Male or female aged 18-85 years.\n6. Normal eyelid anatomy\n7. Patients diagnosed with dry eye for at least 6 months prior to enrollment.\n8. Patients with Symptom Bother score at Baseline of 50.6 or greater.\n9. Patients with a diagnosis of any autoimmune disease.\n10. Patients with one or more corneal neuroma as seen on baseline confocal microscopy.\n11. Patients with partial or total relief of corneal pain with one drop of proparacaine over 15 minutes post-instillation.\n12. No prior use of Acthar Gel SelfJect or otherwise for any indication.\n\nExclusion Criteria:\n\n* 1\\. Have a known hypersensitivity or contraindication to the investigational product or their components.\n\n  2\\. Unwilling to participate in study activities or report for study visits. 3. Current pregnancy or lactation per self-report. Patients who are unwilling to use an effective method of birth control while participating in the study and for four weeks after the last dose of study drug is administered.\n\n  4\\. Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening and for the study, unless the dose has been stable for 14 days.\n\n  5\\. Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.\n\n  6\\. Treatment with another investigational drug or other intervention within 30 days of screening.\n\n  7\\. Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments, limit compliance, or pose safety risks.\n\n  8\\. Systemic medications known to cause dry eye should not be used including antimuscarinics, antihistamines, vitamin A analogs, antianxiety agents, and others unless stable for at least 30 days.",true,{"count":135,"type":20},20,[137],"PHASE4","Single-site, open label pilot study of 20 autoimmune patients diagnosed with dry eye demonstrating via the proparacaine challenge some peripheral corneal pain component. At least 16 patients will receive and complete 12 weeks of 80 units of Acthar Gel to be injected subcutaneously twice weekly via Acthar Gel single-dose pre-filled SelfJectTM injector (SelfJect) to assess the effects on subjective sensation of ocular pain, conjunctival and corneal staining, in vivo assessments of corneal nerves as measured by confocal imaging, VAS scales of common neuropathic pain symptoms and comfort of SelfJect will be assessed.",[140,141,26],"Autoimmune Diseases","Dry Eye",[143,144,145],"Dry eye","Autoimmune","Neurotropic Keratitis","2025-05-09",{"date":148,"type":33},"2025-05-11",{"date":150,"type":33},"2025-02-11",{"date":152,"type":20},"2028-02-28",{"name":154,"class":124},"Toyos Clinic",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":67},"100510514","phase-2-assessment-of-the-initial-efficacy-and-safety-of-brm424-ophthalmic-solutions-in-patients-with-neurotrophic-keratitis-100510514","NCT05927428","Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis","An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)","Inclusion Criteria:\n\n* Be at least 18 years of age;\n* Provide written informed consent;\n* Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);\n\nExclusion Criteria:\n\n* Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK;\n* Anticipated need to use therapeutic contact lenses or contact lens wear for refractive correction during the 28-days Treatment Period in the eye(s) with NK;\n* Be a woman of childbearing potential who is not using an acceptable means of birth control;",{"count":163,"type":20},12,[23],"The objective of this study is to obtain initial efficacy of BRM424 in patients with Stage 2 and Stage 3 NK and evaluate safety and tolerability.",[26],"2024-10-24",{"date":169,"type":33},"2024-10-28",{"date":171,"type":33},"2024-07-31",{"date":173,"type":20},"2025-11-30",{"name":175,"class":40},"BRIM Biotechnology Inc."]