Dry eye syndrome
Conditions
Interventions
MSC Exosome Treatment Group:Umbilical Cord Mesenchymal Stem Cell Exosome Eye Drop Treatment
Sponsors
Shenzhen Nanshan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients who meet the clinical diagnostic criteria for dry eye disease; 2. Moderate to severe dry eye disease (fulfilling one of the following criteria): 1) OSDI score >=23, frequently or consistently accompanied by one or more dry eye symptoms such as dryness, itching, burning sensation, photophobia, eye pressure, gritty sensation, or blurred vision; 2) FBUT = 5 spots, or corneal damage involving >= 2 quadrants, or presenting with punctate confluence, patchy staining, or filaments. 3.Age between 18 and 70 years, regardless of gender or ethnicity; 4. Willing to voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients allergic to the investigational drug or its excipients in this study, or those with a predisposition to allergies; 2. Patients with concurrent active infectious ocular surface diseases or conjunctivitis; 3.Pregnant or lactating women, or those planning a pregnancy within the next year; 4.Patients with severe cardiac, pulmonary, hepatic, renal, or other serious systemic diseases (ALT or AST >= 1.5 times the upper limit of normal, Scr > upper limit of normal); 5.Patients with other incurable ocular conditions, such as ocular chemical burns, eyelid defects, glaucoma, keratoconjunctivitis, nasolacrimal duct obstruction, extensive scarring of the palpebral conjunctiva, uveitis, retinitis pigmentosa, etc.; 6.Patients who wear contact lenses and are unwilling to discontinue their use during the study; 7.Patients who have undergone ophthalmic surgery, including laser therapy or corneal refractive surgery, within the past 3 months; 8.Patients participating in other interventional clinical trials during the same period; 9.Patients who have used eye drops that may interfere with the study within the past 72 hours; 10.Other conditions deemed by the investigator as unsuitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events;Ocular Surface Disease Index (OSDI); | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Blood Count (CBC) ;Liver and Kidney Function Tests;Corneal Fluorescein Staining Score;Fluorescein breakup time(FBUT);Measurement of Tear Meniscus Height;Schirmer's I Test; | — |
Countries
China
Contacts
Public ContactJihui Du
Shenzhen Nanshan People's Hospital
Outcome results
None listed