Dry eye
Conditions
Interventions
Experimental group:Drug name: Lifystre Eye Drops.
Dosage: 1 drop each time (containing approximately 1 mg of Lifystre)
Administration route: Intracorneal instillation.
Administration method: The subje
Control group:Drug name: Lifystre Simulant.
Dosage: 1 drop each time.
Administration route: Eye drops in the conjunctival sac.
Administration method: The subject slightly tilts their head backward, ge
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate and sign the informed consent form. Be willing to follow the treatment schedule stipulated in the trial protocol and be willing to undergo follow-up visits on time. 2. Age >= 18 years old, gender not restricted. 3. Confirmed as dry eye syndrome according to the diagnostic criteria of the "Chinese Expert Consensus on Dry Eye (2020 Edition)". 4. At the screening visit and baseline visit (the first and second visits), the corneal staining score of at least one eye and any one area of the same eye should be >= 2. 5. At the screening visit and baseline visit (the first and second visits), the conjunctival congestion score of at least one eye and the same eye should be >= 1. 6. At the screening visit and baseline visit (the first and second visits), at least one eye and the same eye should simultaneously meet the following two criteria: a. The lower corneal fluorescein staining score (ICSS) >= 0.5; b. Schirmer tear test (STT: without anesthesia) >= 1mm and <= 10mm.
Exclusion criteria
Exclusion criteria: 1. Have ocular herpes or any other infectious diseases, or have ocular infectious diseases within 30 days of the screening period. 2. Have eyelid-related diseases (such as entropion, ectropion, eyelid laxity, etc.), conjunctivochoroidal diseases (severe conjunctival laxity, Salzmann's nodular corneal degeneration, damaged conjunctival goblet cells, pterygium, etc.), retinal diseases (wet age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, etc.), ocular trauma, and any other eye diseases that may affect the test results. 3. Have severe systemic diseases, other autoimmune diseases (rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease, etc.), or have undergone organ or bone marrow transplantation. 4. Have a history of lacrimal punctum plug/tear duct plug surgery within 12 weeks before enrollment; have used antiglaucoma drugs or undergone glaucoma surgery within 3 months before enrollment; have undergone laser posterior capsule opening within 6 months before enrollment; have undergone any other ophthalmic surgery within 12 months before enrollment. 5. Use eye or systemic antihistamines, artificial tears within 72 hours before the baseline visit (the second visit); use cyclosporine eye drops, tacrolimus within 6 weeks before the baseline visit (the second visit); use local or systemic steroids, mast cell stabilizers within 14 days before the baseline visit (the second visit). Have taken aspirin or aspirin-containing drugs orally within 30 days before the baseline visit (the second visit), or have used local or systemic non-steroidal drugs, drugs causing dry eyes (such as anticholinergic drugs, diuretics, etc.). 6. Have worn contact lenses within 30 days before enrollment. 7. Be allergic to fluorescein, be allergic to the drugs in this trial, or have a severe allergic disease. 8. Pregnant or lactating women. 9. Have participated in any drug clinical trials or any medical device trials within 30 days before enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSDI score;NIBUT inspection;MGAP inspection;MGE inspection;LMAS inspection;CFS inspection; | — |
Secondary
| Measure | Time frame |
|---|---|
| CLGS inspection;S?t inspection; | — |
Countries
China
Contacts
Public ContactWang He
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed