This clinical trial aims to preliminarily evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell small extracellular vesicle eye drops in patients with dry eye disease.
1. Human mesenchymal stem cell small extracellular vesicle eye drops:
Administer one drop each time, 4 times daily, for a treatment duration of 4 weeks. 2. During treatment, subjects will be followed up and undergo examinations and related tests weekly. 3. After completion of treatment, follow-up visits will be conducted every 2 weeks for a total of 2 visits. 4. Subsequently, subjects will enter a long-term follow-up period, with follow-up assessments at 3 months and 6 months to observe longer-term safety and efficacy. 5. Subjects shall record medication usage and any possible adverse reactions.
Subjects who voluntarily participate and sign the informed consent form, are willing to comply with the treatment schedule specified in the study protocol, and attend follow-up visits on time.
Aged ≥ 18 years, with no gender restriction.
Best-corrected visual acuity (BCVA) of both eyes (OU) ≥ 0.1 at the Screening Visit (Visit 1, V1).
History of dry eye disease in both eyes prior to the Screening Visit (Visit 1, V1), with at least one of the following subjective symptoms: ocular dryness, foreign body sensation, burning sensation, eye fatigue, discomfort, redness, or fluctuating visual acuity.
Subjects with current ocular herpes or any other ocular infection or inflammation, or a history of ocular herpes or any other ocular infection within 30 days prior to screening.
Subjects with ocular diseases including structural abnormalities of the eyelid margin (ectropion, entropion, eyelid laxity, etc.), severe conjunctivochalasis, Salzmann nodular corneal degeneration, damaged conjunctival goblet cells (e.g., vitamin A deficiency), progressive pterygium, wet age-related macular degeneration (wAMD), glaucoma, diabetic retinopathy, retinal vein occlusion, etc., which, in the investigator's opinion, may increase subject risk or interfere with study outcomes.
Subjects with secondary ocular scarring that, in the investigator's assessment, may affect subject compliance or outcome evaluation (e.g., radiation scars, chemical burns, Stevens-Johnson syndrome, cicatricial pemphigoid, etc.).
Not receiving steroids, immunomodulatory, or immunosuppressive agents for the disease;
Single group
Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops.
Biological/VaccineProduct: Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle (sEV) eye drops. Dosage Form: Sterile ophthalmic solution. Dosing Regimen: Instill one drop into the affected eye(s) four times daily for a treatment duration of 4 weeks. Administration Route: Topical ocular instillation. Follow-up Schedule: Weekly follow-up during the 4-week treatment period. Post-treatment follow-up at Week 6 and Week 8 (every 2 weeks for 2 visits). Long-term follow-up at Month 3 and Month 6 to evaluate sustained safety and efficacy.
Total Corneal Fluorescein Staining Score (TCSS)
To Evaluate Changes in the Total Corneal Fluorescein Staining Score (TCSS) in Subjects
Tear Film Break-up Time (TBUT)
To Observe Changes in Tear Film Break-up Time (TBUT) in Subjects
Click on the lead sponsor to view all of their trials.
