Dry Eye Disease
Conditions
Interventions
Experimental group:MSC eye drops are used twice daily for 2 weeks
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Eligibility
Sex/Gender
Female
Age
40 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. According to the judgment of the investigator, the subject can understand and comply with the requirements of the protocol; 2. Before the start of the research process, the subject or his/her legal representative shall sign and date the written informed consent or any required privacy authorization document; 3. Age 40-60; 4. Female patients 5. The subject has received the treatment of artificial tear sodium hyaluronate, eye drops three times a day, no effect after two weeks of treatment, and the clinical examination results are consistent with: 1) OSDI score = 13; 2) Tear secretion test < 10mm/5min; 3) Tear film rupture time < 10s; 4) The eye surface was stained with fluorescein sodium.
Exclusion criteria
Exclusion criteria: 1. Eye exclusion criteria: 1). Subjects with other eye diseases, such as glaucoma, cataract, uveitis, optic neuritis, etc; 2) The subject has undergone ophthalmic surgery (such as cataract surgery) in recent three months; 3) . Subjects who wear contact lenses for a long time and are unwilling to remove them in the study; 4) . Subjects have received eye drops that may affect the clinical study within the past 24 hours; 2. Exclusion criteria related to infectious diseases: 1) The subject suffers from fungal, bacterial or viral keratitis or conjunctivitis and has evidence of infection; 2) Subjects with chronic hepatitis B virus (HBV) infection or chronic hepatitis C virus (HCV) infection; 3). Subjects suffering from any identified congenital or acquired immunodeficiency (such as various common immunodeficiency human immunodeficiency virus (HIV) infection, organ transplantation); 4) The subject suffers from active tuberculosis (positive TB test); 5) Subjects shall be vaccinated with any live vaccine within 30 days before screening. 3. Exclusion criteria under general conditions: 1) The subject is allergic to the stem cell eye drops; 2). The subject suffers from any unstable or uncontrolled cardiovascular, pulmonary, liver, kidney, gastrointestinal, urogenital, hematological, blood coagulation, immunology, endocrine/metabolic or other medical diseases, and the investigator believes that it will interfere with the research results or endanger the safety of the subject; 3). Subjects had any surgery requiring general anesthesia within 30 days before enrollment, or planned to have major surgery during the study period; 4). Subjects had a history of serious nervous system diseases, including stroke, multiple sclerosis, brain tumors or neurodegenerative diseases; 5) The subject suffers from active psychosis, which the researcher thinks may interfere with his compliance with the research process; 6). Female subjects in lactation period, or female subjects with positive results of serum pregnancy test during screening period, or positive results of urine pregnancy test before drug administration.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index;Schirmer test; | — |
Secondary
| Measure | Time frame |
|---|---|
| Breakup time of tear film;Corneal fluorescein sodium staining; | — |
Countries
China
Contacts
Public ContactKai Hu
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Outcome results
None listed