Dry Eye Syndromes, Mesenchymal Stem Cell
Conditions
Brief summary
The goal of this non-randomized, prospective, open, one-arm clinical study is to learn about the clinical efficacy of stem cell eye drops in patients with dry eye disease (DED) who failed to respond to artificial tear sodium hyaluronate eye drops three times a day for two weeks. The main question aims to answer are: * How effective are stem cell eye drops in patients with DED? * How safe are stem cell eye drops for patients with DED? Participants will be treated with mesenchymal stem cells (MSCs) eye drops, 5×10\^5 /50μl in each eye, twice a day for two weeks and they will be followed up for three months after treatment.
Detailed description
This study was mainly divided into three parts: screening period, treatment period and late treatment period. (1) Screening period: For the DED patients with artificial tear sodium hyaluronate drops three times a day and no effect for two consecutive weeks, OSDI score, fluorescein sodium stain score, tear secretion test and tear film rupture time examination were performed. 10 eligible subjects were screened out according to the inclusion/exclusion criteria, and the subjects were asked to sign informed consent. Relevant clinical examination data were collected and subjects were enrolled. 1) OSDI questionnaire: it was divided into 3 dimensions, including ocular symptoms, visual function, and environmental factors.2) Fluorescein staining score of ocular surface: After staining with 0.25% fluorescein sodium, defect staining was observed under slit lamp microscope. Cornea was scored in 3 areas: top, center and bottom. Each area was scored by 0 points (without any staining), 1 points (partial staining), 2 points (staining of more than half of the area), and 3 points (staining of the whole area). The total was divided into the sum of 3 areas. A higher score indicates more severe ocular surface damage. 3) Schirmer test: Standard tear test paper was taken and held in the conjunctival sac at 1/3 of the lower outer eyelid, and the patient was instructed to close the eyes gently. The results were observed 5 minutes later. The tear secretion test \< 10mm/5min was abnormal. 4) Tear break-up time: After staining with 0.25% fluorescein sodium, patients were instructed to close their eyes under the slit lamp microscope. The tear film rupture time was calculated from the time of eye opening to the appearance of the first burst spot, and the average value was taken for three consecutive tests. The rupture time of tear film was less than 10s. (2) Treatment period: Formal clinical treatment: 10 enrolled patients received MSC eye drops twice a day for two weeks. OSDI score, ocular fluorescein sodium stain score, tear secretion test and tear film rupture time examination were performed every weekend during drug administration. Adverse events, serious adverse events and drug-related adverse events ≥Ⅲ during treatment were recorded to evaluate drug safety. (3) Late treatment: 3 months of follow-up after the end of treatment. OSDI score was performed during weekly telephone follow-up, and clinical indicators (OSDI score, fluorescein sodium staining score of ocular surface, tear secretion test and tear film rupture time test) were examined every four weeks to evaluate the treatment effect of DED.
Interventions
DRUGMSCs eye drops
MSCs were used to prepare single-cell suspension, and 0.9% sodium chloride was added to balance PH value to prepare the effective, safe and stable eye drops. Giving the patient with 5×10\^5 /50μl in each eye, twice a day for 2 weeks.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Inclusion Criteria: 1. As determined by the investigator, the subject is able to understand and comply with the protocol requirements; 2. Subject or subject's legal representative (if applicable) sign and date the written informed consent or any privacy authorization document required prior to the commencement of the study process; 3. Age 40-60; 4. Female patients; 5. The subject has received artificial tear sodium hyaluronate treatment with eye drops three times a day, but the treatment has no effect for two weeks, and the clinical examination results are consistent with: * OSDI score ≥13; * Schirmer test \< 10mm/5min; * Tear break-up time \< 10s; * Fluorescein sodium staining on the ocular surface was positive. 2.
Exclusion criteria
1. Eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of OSDI score | 1 week | OSDI questionnaire: It was divided into 3 dimensions, including ocular symptoms, visual function, and environmental factors. The total score is less than 13. |
| The change of Schirmer test | 1 week | Standard tear test paper was taken and held in the conjunctival sac at 1/3 of the lower eyelid, and the patient was instructed to close the eyes gently. The results were observed 5 minutes later. Schirmer test \< 10mm/5min was abnormal. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tear break-up time | 1 week | After staining with 0.25% fluorescein sodium, patients were instructed to close their eyes under the slit lamp microscope. The tear film rupture time was calculated from the time of eye opening to the appearance of the first burst spot, and the mean value was taken for three consecutive tests. The tear film rupture time \< 10s is abnormal |
| Fluorescein sodium staining of the ocular surface. | 1 week | After staining with 0.25% fluorescein sodium, defect staining was observed under slit lamp microscope. Cornea was scored in 3 areas (FIG. 1) : top, center and bottom. Each area was scored according to 0 points (without any staining), 1 points (partial staining), 2 points (staining of more than half of the area) and 3 points (staining of the whole area), and the total was divided into the sum of 3 areas. A higher score indicates more severe ocular surface damage. |
Countries
China
Outcome results
None listed