[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622348":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":44,"centralContacts":45,"locations":44,"responsibleParty":55,"collaborators":44,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":44,"eligibilityCriteria":63,"healthyVolunteers":59,"sex":64,"minAge":65,"maxAge":66,"enrollmentInfo":67,"targetDuration":44,"studyType":70,"phases":71,"briefSummary":73,"conditions":74,"keywords":44,"overallStatus":76,"whyStopped":44,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":44},{"fullName":5,"class":6},"Affiliated Hospital of Nantong University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Exo treatment","EXPERIMENTAL","Following a 14-day placebo run-in period-during which all subjects receive bilateral placebo eye drops (one drop per eye, twice daily, approximately 12 hours apart)-participants will receive active treatment for 84 days: Group 1 (Exo) receives 10 μg\u002Fdrop of unmodified MSC-Exos.",[13],"Drug: Exosomes",{"label":15,"type":10,"description":16,"interventionNames":17},"tRF-ASO-Exo treatment","Following a 14-day placebo run-in period-during which all subjects receive bilateral placebo eye drops (one drop per eye, twice daily, approximately 12 hours apart)-participants will receive active treatment for 84 days:Group 2 (tRF-ASO-Exo) receives 10 μg\u002Fdrop of tRF-ASO-engineered MSC-Exos.",[18],"Drug: tRNA-derived fragments-antisense oligonucleotides-exosomes",{"label":20,"type":10,"description":21,"interventionNames":22},"tRF-ASO-Exo-PAE treatment","Following a 14-day placebo run-in period-during which all subjects receive bilateral placebo eye drops (one drop per eye, twice daily, approximately 12 hours apart)-participants will receive active treatment for 84 days:Group 3 (tRF-ASO-Exo-PAE) receives 10 μg\u002Fdrop of tRF-ASO-engineered MSC-Exos delivered via PAE hydrogel.",[23],"Drug: poly（β-amino ester）hydrogel loaded with tRNA-derived fragments-antisense oligonucleotides-exosomes",[25,32,38],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Exosomes","Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by Exosomes 10ug\u002Fdrop, two times a day for 84 days. The follow-up visit will be 12 weeks.",[9],[31],"Exo",{"type":26,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"tRNA-derived fragments-antisense oligonucleotides-exosomes","Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by tRF-ASO-Exo 10ug\u002Fdrop, two times a day for 84 days. The follow-up visit will be 12 weeks.",[15],[37],"tRF-ASO-Exo",{"type":26,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"poly（β-amino ester）hydrogel loaded with tRNA-derived fragments-antisense oligonucleotides-exosomes","Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by tRF-ASO-Exo-PAE 10ug\u002Fdrop, two times a day for 84 days. The follow-up visit will be 12 weeks.",[20],[43],"tRF-ASO-Exo-PAE",null,[46,51],{"name":47,"role":48,"phone":49,"phoneExt":44,"email":50},"Min Ji","CONTACT","0513(81160554)","amyji1234@hotmail.com",{"name":52,"role":48,"phone":53,"phoneExt":44,"email":54},"Xi Zhu","0513-81160554","806549014@qq.com",{"type":56,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR","100622348","phase-2-effect-of-pae-hydrogel-loaded-with-trf-aso-exo-on-patients-with-diabetic-ocular-surface-diseases-100622348",false,"NCT07382453","Effect of PAE Hydrogel Loaded With tRF-ASO-Exo on Patients With Diabetic Ocular Surface Diseases","Effect of Poly（β-amino Ester）Hydrogel Loaded With tRNA-derived Fragments-antisense Oligonucleotides-exosomes on Patients With Diabetic Ocular Surface Diseases","Inclusion Criteria:\n\n* 1\\. Patients with fasting blood glucose ≥ 7.0 mmol\u002FL or 2-hour postprandial blood glucose ≥ 11.1 mmol\u002FL.\n\n  2\\. Those who clearly understand and voluntarily participate in this study, and sign the written informed consent form themselves, and are able and willing to follow the instructions to participate in all trial evaluations and visits.\n\n  3\\. Male subjects and female subjects of childbearing age must agree to use medically approved contraceptive measures during the trial and for 90 days after the trial. For female subjects who have not reached menopause or have been menopausal for less than two years, the pregnancy test must be negative.\n\n  4\\. A history of severe dry eye symptoms (including one or more of the following subjective symptoms: dryness, foreign body sensation, burning sensation, fatigue, discomfort, redness, sudden eye pain, photophobia, tearing, blurred vision, and decreased corneal sensation) in both eyes for at least 180 days before the screening visit (Visit 0).\n\n  5\\. Currently (within 30 days before Visit 0) using artificial tears to relieve dry eye-related symptoms, and artificial tears must be discontinued 72 hours before Visit 0.\n\n  6\\. At Visit 0, the Chinese Dry Eye Questionnaire score is \\> 7 points or the total score of the Ocular Surface Disease Index is \\> 13 points.\n\n  7\\. At Visit 0 and Visit 1, the dryness score is \\> 40 points. 8. At Visit 0, the best corrected visual acuity of both eyes is ≥ 4.3 (5-meter reading on the international standard logarithmic visual acuity chart, 5-point recording method).\n\n  9\\. At Visit 0 and Visit 1, the corneal fluorescein staining score of at least one area of at least one eye is ≥ 2 points.\n\n  10\\. At Visit 0 and Visit 1, the conjunctival redness score of at least one eye is ≥ 1 point.\n\n  11\\. At the screening visit and baseline visit (Visit 0 and Visit 1), at least one eye of the same subject meets the following criteria: a. The corneal lower zone fluorescein staining score is ≥ 0.5 points; b. The Schirmer's test without anesthesia is ≥ 1 and ≤ 10 mm\u002F5 min.\n\nExclusion Criteria:\n\n1. Any past or current malignancy in or around the eye.\n2. Dry eye traced to scarring (radiation, alkali burn, Stevens-Johnson, cicatricial pemphigoid) or goblet-cell loss (vitamin-A deficiency).\n3. Active ocular allergy now or expected during the study.\n4. Ocular or systemic infection at screening\u002Fbaseline-fever, herpetic keratitis, or on antibiotics.\n5. Prior immunodeficiency, HIV, hep B\u002FC, active hep A, organ or bone-marrow transplant.\n6. Any serious chronic illness the PI thinks could mess with endpoints-severe heart\u002Flung disease, uncontrolled hypertension or diabetes.\n7. Blood donation or major blood loss within 8 weeks of screening.\n8. Active ocular rosacea, periorbital acne, or pterygium.\n9. Lid problems-lagophthalmos, entropion, ectropion, or abnormal blink.\n10. Clinically relevant slit-lamp findings needing treatment (conjunctivitis, trichiasis, conjunctivochalasis) that could skew results.\n11. Eye surgery or laser (including YAG, meibomian thermopulsation, IPL) within 6 months of screening, or any such plan during the trial.\n12. Punctal plugs (non-dissolvable within 90 days; dissolvable within 180 days) or planned plug procedures during the study.\n13. Systemic steroids, immunomodulators, oral doxy\u002Ftetracycline within 90 days, or on-and-off use planned.\n14. Topical glaucoma meds within 90 days.\n15. Cyclosporine-A or lifitegrast drops within 42 days.\n16. Drugs well known to dry the eye-diuretics, antidepressants, decongestants, antispasmodics, antihistamines, etc.-within 30 days or irregular use expected.\n17. Active blepharitis\u002FMGD therapy (lid scrubs, meibomian massage, warm compresses, systemic antibiotics) within 30 days or sporadic use planned.\n18. Topical steroid or mast-cell stabilizer on the eye\u002Fface within 2 weeks.\n19. Contact-lens wear within 7 days or intent to keep wearing them during the study.","ALL","18 Years","70 Years",{"count":68,"type":69},30,"ESTIMATED","INTERVENTIONAL",[72],"PHASE2","The purpose of this study is to determine whether poly（β-amino ester）(PAE)hydrogel loaded with tRNA-derived fragments-antisense oligonucleotides-exosomes(tRF-ASO-Exo) could alleviate symptoms in patients with diabetic ocular surface diseases(DOSD).",[75],"Diabetic Keratopathy","NOT_YET_RECRUITING","2026-02-02",{"date":79,"type":80},"2026-02-04","ACTUAL",{"date":82,"type":69},"2026-02-15",{"date":84,"type":69},"2029-06-30",{"name":5,"class":6}]