dry eye
Conditions
Interventions
People with severe dry eyes:Mesenchymal stem cell apoptotic vesicle eye drops eye drop therapy
Sponsors
Shenzhen Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this clinical trial and sign an informed consent form. 2. Sex is not limited and age ranges from 18 to 70 years old. 3. Meet the diagnostic criteria for severe dry eye according to the Expert Consensus on Clinical Management of Dry Eye: Definition and Classification, and discontinue other dry eye medications for more than 1 week. 4. Have not participated in a clinical trial of another drug within 3 months of the trial.
Exclusion criteria
Exclusion criteria: 1. Allergic persons and persons who are allergic to any of the components of the test drug. 2. Patients with a proposed clinical diagnosis of active fungal, bacterial, or viral keratitis or conjunctivitis. 3. Those who have a combination of other ocular diseases that affect the evaluation of efficacy, such as significant lesions of the cornea, conjunctiva and iris, macular degeneration, glaucoma and retinal vascular embolism. 4. Combined serious systemic diseases such as serious cardiac, cerebrovascular, hepatic, renal and hematopoietic systems. 5. Those who have had internal eye surgery or eye trauma within the last six months. 6. Those who received tear duct embolization within the last 1 month. 7. Patients who are receiving local or systemic therapy that may affect the evaluation of efficacy. 8. Pregnant or breastfeeding women or those who plan to have children in the near future. 9. Those with a history of wearing corneal contact lenses in the week prior to enrollment or those who were unable to stop wearing corneal contact lenses during the trial. 10. Those who were unable to ensure that the medication was administered and followed up as required during the trial. 11. Those who have participated in other clinical trials within the last 3 months. 12. Patients who are unable to cooperate or who are mentally ill. 13. Persons who, in the opinion of the investigator, should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescein staining of tear film rupture time;fluorescein staining of the cornea;Blepharoplasty evaluation;Assessment of conjunctival relaxation;Tear secretion test (Schirmer ?, without surface anesthesia);Blepharoplasty evaluation;Evaluation of conjunctival congestion; | — |
Countries
China
Contacts
Public ContactChi Wei
Shenzhen Eye Hospital
Outcome results
None listed