[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BRIM Biotechnology Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":79},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,31,57],{"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":4,"targetDuration":4,"studyType":18,"phases":4,"briefSummary":19,"conditions":20,"keywords":4,"overallStatus":22,"whyStopped":4,"lastUpdateSubmitDate":23,"lastUpdatePostDateStruct":24,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":27,"locationsCount":30},"100625419","brm421-ophthalmic-solution-in-patients-with-limbal-stem-cell-deficiency-100625419",false,"NCT07422389","BRM421 Ophthalmic Solution in Patients With Limbal Stem Cell Deficiency","Intermediate-Size Patient Population Use of BRM421 Ophthalmic Solution in Patients With Limbal Stem Cell Deficiency","Inclusion Criteria:\n\n* Adult patients with mild to moderate LSCD who unsatisfied with the standard of care treatments and who seek the treatment with BRM421 Ophthalmic Solution. Patients scheduled for LSC transplant may be included, but treatment with BRM421 should begin only after the surgery.\n* Be able to sign the informed consent and follow with investigator instructions.\n* If a female is of childbearing potential, they must: use an acceptable means of birth control (acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives, mechanical spermicide in conjunction with a barrier such as a diaphragm or condom, IUD, or surgical sterilization of partner) and have a negative urine pregnancy test at the time of consent.\n\nExclusion Criteria:\n\n* The patients eligible for the BRIM clinical trial(s).\n* The patients diagnosed with primary LSCD which is the genetic mutations that lead to LSC dysfunction or destruction.\n* Have a condition or a situation in which the investigator feels the patients is not suitable and may put the patient at significant risk.\n* Be a female who is pregnant, nursing, or planning a pregnancy at the time of consent. Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception include: hormonal oral, implantable, injectable, or transdermal contraceptives; mechanical spermicide in conjunction with a barrier such as a diaphragm or condom; IUD; or surgical sterilization of partner. The risks of BRM421 among pregnant patients are not known.","ALL","18 Years","EXPANDED_ACCESS","The goal of this program is to provide patients with Limbal Stem Cell Deficiency access to the BRM421 eye drops.\n\nParticipants will:\n\n* Use BRM421 two times a day for at least 12 weeks\n* Visit the clinic monthly for checkups and tests",[21],"Limbal Stem Cell Deficiency (LSCD)","AVAILABLE","2026-02-12",{"date":25,"type":26},"2026-02-20","ACTUAL",{"name":28,"class":29},"BRIM Biotechnology Inc.","INDUSTRY",1,{"id":32,"slug":33,"hasResults":11,"nctId":34,"briefTitle":35,"officialTitle":36,"acronym":4,"eligibilityCriteria":37,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":38,"targetDuration":4,"studyType":41,"phases":42,"briefSummary":44,"conditions":45,"keywords":4,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":52,"completionDateStruct":54,"leadSponsor":56,"locationsCount":30},"100599012","phase-2-a-dose-regimen-study-of-brm421-ophthalmic-solution-in-patients-with-dry-eye-disease-100599012","NCT07078955","A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease","A Phase 2, Multicenter, Randomized, Open-Labeled, Artificial Tear-Controlled, 6-Week Clinical Study to Assess the Dose Regimen, Safety and Efficacy of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease","Inclusion Criteria:\n\n* Are ≥18 years of age;\n* Are willing and able to comply with all study procedures and restrictions and the visit schedule;\n* Have a self-reported history of dry eye prior to enrollment;\n* If a woman of childbearing potential (WOCBP): are non-lactating, have a negative urine pregnancy test (UPT), and agree to use an acceptable form of contraception for the duration of the study;\n\nExclusion Criteria:\n\n* Within 3 months prior to Visit 1, have participated in any other investigational study or used an investigational product or device;\n* Have any history of organ or bone marrow transplant, immunodeficiency disorder, human immunodeficiency virus, or hepatitis C, or any evidence of acute active hepatitis A (anti-hepatitis A virus immunoglobulin M);\n* Have any significant illness or condition that, in the opinion of the Investigator, could affect the study outcome measures. Such illnesses include (but are not limited to) Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, severe cardiopulmonary disease, poorly controlled hypertension or diabetes, or drug\u002Falcohol addiction;\n* Within 12 months prior to Visit 1, have undergone any ocular surgical procedure, including laser-assisted in situ keratomileusis (LASIK) or a similar corneal refractive surgery;",{"count":39,"type":40},99,"ESTIMATED","INTERVENTIONAL",[43],"PHASE2","To evaluate the safety and efficacy of BRM421 Ophthalmic Solution compared to artificial tear for treatment of the signs and symptoms of dry eye disease (DED)",[46,47],"Dry Eye Disease (DED)","Keratoconjunctivitis Sicca","NOT_YET_RECRUITING","2025-10-16",{"date":51,"type":26},"2025-10-20",{"date":53,"type":40},"2025-12",{"date":55,"type":40},"2027-03",{"name":28,"class":29},{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":4,"eligibilityCriteria":63,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":64,"targetDuration":4,"studyType":41,"phases":66,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":30},"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":65,"type":40},12,[43],"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.",[69],"Neurotrophic Keratitis","RECRUITING","2024-10-24",{"date":73,"type":26},"2024-10-28",{"date":75,"type":26},"2024-07-31",{"date":77,"type":40},"2025-11-30",{"name":28,"class":29},""]