Dry Eye Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria:1.Meet the clinical diagnostic criteria for dry eye disease (DED);2.Aged 18 to 75 years (inclusive), regardless of gender;3.Have not used other DED therapeutic agents (including topical eye drops and systemic medications that may affect tear secretion) within 2 weeks prior to enrollment, or have discontinued such medications and completed a washout period of at least 2 weeks;4.Be fully informed and voluntarily sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1.Concurrent active ocular diseases, such as acute ocular infections, severe allergic conjunctivitis, glaucoma, uveitis, or anatomical eyelid abnormalities;2.Secondary dry eye disease caused by systemic autoimmune diseases (e.g., Sjögren's syndrome, systemic lupus erythematosus, rheumatoid arthritis) or thyroid-associated ophthalmopathy;3.History of ocular trauma or ocular surgery (especially corneal refractive surgery) within the past 6 months;4.Use of contact lenses (including soft contact lenses or orthokeratology lenses) within the past 4 weeks;5.Severe dysfunction of vital organs (e.g., heart, liver, or kidneys), hematopoietic system diseases, or malignant tumors;6.Women who are pregnant, lactating, or planning to become pregnant during the study period;7.Psychiatric or cognitive disorders, or poor compliance making the patient unable to complete treatment and follow-up procedures as judged by the investigator;8.Participation in other clinical trials for drugs or medical devices within the 3 months prior to enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ocular Surface Disease Index (OSDI) score;tear break-up time(TBUT); | — |
Secondary
| Measure | Time frame |
|---|---|
| Schirmer I test(SIT);corneal fluorescein staining(CFS);Tear inflammatory cytokines;Vision-Related Quality of Life(VRQOL); | — |
Countries
China
Contacts
Quzhou Traditional Chinese Medicine Hospital