Actively Recruiting
Clinical Study on the Treatment of Dry Eye With Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles Eye Drops
Led by The First Affiliated Hospital of Xiamen University · Updated on 2026-06-03
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of eye drops made from human umbilical cord mesenchymal stem cell small extracellular vesicles in adults with dry eye disease. This early-phase clinical trial focuses on patients who have a history of dry eye disease with specific symptoms and clinical signs, aiming to understand how these eye drops may help relieve their condition. Participants will receive one drop of these stem cell-derived eye drops four times a day for four weeks. During this treatment period, they will visit the clinic weekly for examinations and tests. After completing treatment, follow-up visits will occur every two weeks for two visits, followed by longer-term follow-ups at three and six months to observe sustained safety and potential benefits. Throughout the study, participants will record their medication use and any side effects. Researchers will assess eye health using measures such as the Total Corneal Fluorescein Staining Score and Tear Film Break-up Time at four weeks. Safety and effectiveness will be monitored closely during treatment and follow-up visits, with the total participation spanning over six months to gather long-term data.
CONDITIONS
Brief Title
Human Umbilical Cord Mesenchymal Stem Cell-derived Small Extracellular Vesicles for the Treatment of Dry Eye Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older who voluntarily agree to participate and sign informed consent
- Willingness to follow the treatment schedule and attend all follow-up visits
- Best-corrected visual acuity of both eyes at least 0.1 at screening
- History of dry eye disease in both eyes with at least one symptom such as dryness, burning, foreign body sensation, eye fatigue, discomfort, redness, or fluctuating vision
- Meeting specific clinical criteria for dry eye, including positive corneal fluorescein staining with tear film break-up time under 10 seconds and OSDI score of 13 or higher, or negative staining with tear film break-up time under 5 seconds and OSDI score of 13 or higher
You will not qualify if you...
- Current or recent (within 30 days) ocular herpes, infection, or inflammation
- Ocular diseases that may increase risk or affect outcomes, such as eyelid structural abnormalities, severe conjunctivochalasis, certain corneal degenerations, wet age-related macular degeneration, glaucoma, diabetic retinopathy, or retinal vein occlusion
- Secondary ocular scarring affecting compliance or evaluation
- Secondary Sjögren's syndrome or autoimmune diseases unless not using immunosuppressive drugs and deemed stable
- History of organ or bone marrow transplantation
- Contact lens use within 30 days prior to screening
- Recent physical therapy for dry eye within 30 days
- Use of certain medications affecting eyes within defined timeframes before dosing
- Punctal plugs or cautery history within 12 weeks
- Recent glaucoma surgeries or laser treatments
- Recent corneal refractive surgery within 12 months
- Known severe allergies or multiple drug allergies
- Poorly controlled serious medical conditions
- Pregnancy, lactation, or unwillingness to use contraception during study and 1 month after
- Participation in other clinical trials within 30 days prior to screening
- Any other conditions making the participant unsuitable in the investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants instill one drop of Human umbilical cord mesenchymal stem cell-derived small extracellular vesicle eye drops into the affected eye(s) four times daily for 4 weeks.
Weekly visits during the 4-week treatment period
Duration - Up to 6 months
Participants attend follow-up visits to evaluate sustained safety and efficacy after treatment.
Visits at Week 6, Week 8, Month 3, and Month 6
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, China, China, 361000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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