Dry Eye Disease
Conditions
Interventions
Control group:None
moderate and severe Dry eye group:None
mild Dry eye group:None
Sponsors
Eye Hospital, Wenzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-65 years; 2. Dry eye symptoms (at least one of the subjective symptoms such as eye dryness, foreign body sensation, burning sensation, fatigue, discomfort, and eye redness) for more than 6 months and an OSDI score of 23-80 points at the initial screening; 3. Three or more of the following 5 signs are present at initial screening: (1) Conjunctival staining score >= 1 in one eye (up to 6 points in one eye); (2) Corneal fluorescence staining score >= 4 in one eye (up to 15 points in one eye) with a single regional score >= 2 points; (3) TFBUT = 2); 4. The control group population meets the following requirements: (1) Uniocular conjunctival staining score 5 s; (4) Schirmer's test (epianaesthesia) >= 7 mm/5 min; (5) Inflammation graded as mild (HI < 2) as judged by the eye redness index; 5. Willing and able to cooperate in completing all examinations and able to follow the instructions of the investigator.
Exclusion criteria
Exclusion criteria: 1. A history of eye or systemic malignant tumors, or being monocular; 2. Currently diagnosed with any of the following eye conditions: (1) Acute allergic conjunctivitis; (2) Infections (bacterial, viral, protozoal, or fungal infections of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelid); (3) Inflammation not caused by dry eye (retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis); 3. Currently having eye or systemic infections, including fever, infectious keratoconjunctivitis, or undergoing antibiotic treatment; 4. History of wearing contact lenses in the past 2 weeks; 5. History of eye surgery (including refractive surgery, cataract surgery) or eye trauma in the past 3 months; 6. History of herpetic keratitis; 7. Eyelid abnormalities affecting eyelid function (such as incomplete eyelid closure, eyelid spasm, ectropion, entropion, severe trichiasis, etc.); 8. Extensive ocular surface scarring or conditions that may affect ocular surface integrity, such as Stevens-Johnson syndrome, previous chemical burns, recurrent corneal epithelial erosion, persistent corneal epithelial defects, or previous eye trauma; 9. Use of topical immunosuppressants or steroid eye drops in the past month; 10. Use of antihistamines, cholinergic drugs, beta-blockers, antidepressants, or any medications that may cause dry eye in the past month; 11. History of punctal occlusion in the past 3 months; 12. Currently have any of the following systemic diseases: HIV infection, history of organ or bone marrow transplantation, cicatricial pemphigoid, Sjögren's syndrome, or other systemic autoimmune diseases; 13. Pregnant, breastfeeding, menopausal, or using hormone replacement therapy; 14. Other conditions that the researcher deems unsuitable for participating in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage and number of immune cells;Tear protein expression level; | — |
Countries
China
Contacts
Public ContactWei Chen
Eye Hospital, Wenzhou Medical University
Outcome results
None listed