[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ocular-graft-versus-host-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ocular-graft-versus-host-disease":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"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":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100652635","phase-3-study-of-d-mapps-ophthalmic-solution-in-adults-with-chronic-ocular-graft-versus-host-disease-ogvhd-100652635",false,"NCT07776210","Study of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD)","A Randomized, Double-Masked, Vehicle-Controlled, Adequate and Well-Controlled Pivotal Study With Co-Primary Endpoints to Evaluate the Safety and Efficacy of d-MAPPS™ Ophthalmic Solution in Subjects With Chronic Ocular Graft-Versus-Host Disease (oGVHD)","Inclusion Criteria:\n\n* Age 18 years or older.\n* Documented chronic ocular graft-versus-host disease (oGVHD) following allogeneic hematopoietic stem cell transplantation.\n* Investigator determines the participant is medically stable and appropriate for study participation.\n* Ocular Surface Disease Index (OSDI) Total Score of at least 33 at Baseline.\n* UNC Dry Eye Management Scale Visual Analog Scale (UNC DEMS VAS) score of at least 3 at Baseline.\n* Modified Oxford Corneal Staining Score of at least 1 in at least one eye.\n* Snellen Corrected Distance Visual Acuity sufficient to complete protocol-defined assessments.\n* Written informed consent obtained before study procedures.\n* Willing and able to comply with study visits, study treatment, and protocol requirements.\n* Background therapies stable for at least 30 days before Baseline.\n\nExclusion Criteria:\n\n* Acute ocular graft-versus-host disease or ocular disease that may interfere with efficacy assessment.\n* Active ocular or periocular infection, ocular malignancy, or active herpetic keratitis.\n* Intraocular surgery, refractive surgery, or ocular laser procedure within 6 weeks before Baseline or planned during the study.\n* Change in systemic immunosuppressive therapy, topical glaucoma therapy, or oral tetracycline therapy within 30 days before Baseline.\n* Initiation within 30 days before Baseline or during the trial of topical cyclosporine, lifitegrast, tacrolimus, autologous serum eye drops, platelet-rich plasma eye drops, amniotic membrane products, or another prescription therapy intended to treat ocular surface disease.\n* Participation in another investigational study within 30 days before Screening or concurrent enrollment.\n* Pregnancy or breastfeeding.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","This is a Phase III, multicenter, randomized, double-masked, vehicle-controlled, parallel-group clinical trial designed to evaluate the efficacy, safety, and tolerability of d-MAPPS™ Ophthalmic Solution in adult subjects with chronic ocular graft-versus-host disease (oGVHD). Eligible subjects will receive masked study treatment for 90 days, with the primary efficacy assessment performed at the Day 90 study visit.",[26,27],"oGVHD","Ocular Graft Versus Host Disease",[26,29,27],"Ocular Graft-Versus-Host Disease","NOT_YET_RECRUITING","2026-08-20",{"date":33,"type":34},"2026-08-21","ACTUAL",{"date":36,"type":20},"2026-08-19",{"date":38,"type":20},"2027-06-30",{"name":40,"class":41},"Regenerative Ocular Immunobiologics LLC","INDUSTRY",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":69},"100602034","phase-2-a-phase-ii-prospective-randomized-double-masked-crossover-study-assessing-the-safety--efficacy-of-rhprg4-450-gml-recombinant-human-proteoglycan-4-compared-to-vehicle-for-the-treatment-of-ocular-graft-versus-host-disease-ogvhd-100602034","NCT07118254","A PHASE II PROSPECTIVE RANDOMIZED DOUBLE-MASKED CROSSOVER STUDY ASSESSING THE SAFETY & EFFICACY OF RHPRG4 (450 μG\u002FML RECOMBINANT HUMAN PROTEOGLYCAN 4) COMPARED TO VEHICLE FOR THE TREATMENT OF OCULAR GRAFT-VERSUS-HOST DISEASE (OGVHD)","Inclusion Criteria:\n\n1. Have the ability to comprehend and provide a signed and dated consent form.\n2. Are 18-80 years of age at time of consent;\n3. Have been diagnosed with oGVHD for at least 3 months prior to giving informed consent to participate in the trial;\n4. Current use of artificial tears for the treatment of oGVHD related dry eye;\n5. Have been stably using systemic medications for at least 14 days prior to Visit 1;\n6. VAS Eye Dryness (100-point scale) score ≥ 40 mm;\n7. Average VAS score for all symptoms of dry eye (dryness, foreign body sensation, burning\u002Fstinging, itching, pain, stick feeling, blurred vision and photophobia) ≥ 25 mm, none \\\u003C 5 mm;\n8. Have Oxford corneal fluorescein staining grade of ≥ 2 using the Oxford scale in the worst performing eye\n9. Stated willingness to comply with all study procedures, attend all scheduled clinic visits, and continue participation for the duration of the study;\n10. Ability to self-administer study medication and willingness to adhere to the medication regimen.\n\nExclusion Criteria:\n\nAre currently or have a history of any ocular or systemic disorder or condition other than dry eye that based on investigator judgment will interfere with the interpretation of the study results. Examples of ocular or systemic disorders or conditions include active ocular infection, conjunctivochalasis, superior limbic keratoconjunctivitis, limbal stem cell deficiency, allergic conjunctivitis, giant papillary conjunctivitis, atopic keratoconjunctivitis, anterior basement membrane dystrophies, neurotrophic keratitis, corneal dystrophy, exposure keratitis, moderate to severe blepharitis, ocular trauma, progressive or degenerative corneal conditions, uveitis, and systemic infection; 2. History of any ocular surgery (including laser or refractive surgical procedures) or therapeutic medical devices in either eye within 30 days before study enrollment. Therapeutic medical devices include trigeminal stimulation, meibomian glad warming (excepting at home masks) or expression, intense pulsed light, low level light therapy, etc. Ocular surgeries include laser or refractive surgical procedures, insertion of punctal or punctal cauterization; Ocular surgery will not be allowed during study participation; 3. Initiation of new therapeutic modalities within 14 days of Visit 1; 4. Have a known hypersensitivity to one of the components of the study or procedural medications; 5. Have participated in another clinical study at the same time as the present study or within 30 days of the Visit 1; 6. Have a history of drug, medication or alcohol abuse or addiction; 7. Are females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) who meet any one of the following conditions:\n\n1. are currently pregnant or,\n2. have a positive result on the urine pregnancy test at the Screening\u002FBaseline Visit or,\n3. intend to become pregnant during the entire course of and 30 days after the study treatment periods, or,\n4. are breast-feeding or,\n5. not willing to use highly effective birth control measures, such as: hormonal contraceptives - oral, implanted, transdermal, or injected and\u002For mechanical barrier methods, during the entire course of and 30 days after the study treatment periods; 8. Per the discretion of the investigator or designee, history of a serious physical or mental disorder that prevents the subject from attending study visits, complying with study-related procedures, and\u002For prevents the subject's ability to make decisions on their own; 9. Any other surgical or medical condition or finding that in the opinion of the investigator would compromise the subject's safety or participation in the study.","75 Years",{"count":51,"type":20},15,[53],"PHASE2","An 84-day, prospective, randomized (1:1) vehicle controlled, double-masked pre-market, crossover study. Subjects with moderate to severe oGVHD related Dry Eye Disease Each subject will receive both treatments in random sequence, each for 28 days, separated by a 14-day vehicle washout period.",[27],[26,57,58],"Dry Eye","Graft Versus Host Disease","RECRUITING","2026-01-16",{"date":62,"type":34},"2026-01-20",{"date":64,"type":34},"2025-09-17",{"date":66,"type":20},"2026-12",{"name":68,"class":41},"Lubris Bio Pty Ltd",3]