Dry Eye Disease
Conditions
Interventions
test group:0.1% tacrolimus eye drops, bid/tid+artificial tear, q.i.d
control group:vehicle, b.i.d/t.i.d+artificial tear, q.i.d
Sponsors
Tianjin Medical University Eye Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years; 2. Patient who will be able to follow up once a month for at least 3 months; 3. Patient who can understand the step treatment and adverse events of the trial and be willing to join the test and signature informed consent; 4. Patient who can ensure all the clinical records are available for researchers during follow-up course and can communicate well with researchers; 5. Vision Ability=0.1; 6. Patient who has moderate and severe dry eye.
Exclusion criteria
Exclusion criteria: 1) Highly sensitive to tacrolimus and/or highly sensitive to any drug; 2) Patient who has received any other test drug a month ago before being screened or enrolled for this month 3) In addition to cataracts, there are other ocular diseases affecting vision, such as glaucoma, diabetic retinopathy, retinal detachment, etc.; 4) In the application or treatment of immunosuppressive agents other than tacrolimus 5) Patient who has severe heart, liver, kidney disease; 6) History of drug abuse, history of drug abuse, or history of malignancy; 7) Severe, repetitive and chronic infections after organ transplantation or in the near future, including HIV, hepatitis, tuberculosis, syphilis, etc.; 8) Have fertility requirements or are in pregnancy or lactation; 9) Patient who has psychological and mental disorders; 10) Contact lens use or current or recent use of punctal plugs; 11) Have used drugs that clearly affect the results and/or used another research drug in the past 30 days; 12) Recently performed eye surgery or planned to undergo eye surgery during the study; 13) Patient who is not eligible for inclusion judged by clinical investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSDI;BUT;Schirmer ?test;Corneal Fluorescein Sodium Staining; | — |
Countries
China
Contacts
Public ContactZhao Shaozhen
Tianjin Medical University Eye Hospital
Outcome results
None listed