Dry Eye Disease
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Sign the informed consent approved by the ethics committee; 2. Be between 18 and 45 years old; 3. Meet the DEWS III criteria for dry eye diagnosis; 4. Have at least 2 lifestyle factors that can be intervened; 5. Have a best-corrected visual acuity of at least 10/20 in one eye; 6. Have intraocular pressure (IOP) between 10 mmHg and 21 mmHg in one eye; 7. Women of childbearing potential must agree to use reliable contraception during the study and provide a negative urine pregnancy test at the screening visit; 8. Be able to attend all visits and willing to follow the study investigator's instructions.
Exclusion criteria
Exclusion criteria: 1. Slit-lamp microscope examination shows corneal damage in 2 or more quadrants and/or corneal fluorescein staining points >= 30, BUT < 2 s. Corneal fluorescein spots merge into coarse spots, patches, or are accompanied by filaments; 2. Contact lens wearing history: (1) Used contact lenses within the last 14 days before baseline; (2) Unwilling to avoid using contact lenses affecting the study; 3. Any corneal surgery in the 12 months before baseline; 4. Participation in other medical study visits in the 3 months before baseline; 5. Currently or previously diagnosed in the past 3 months with any of the following eye diseases: (1) Acute allergic conjunctivitis; (2) Infection (such as bacterial, viral, protozoal, or fungal infection of the cornea, conjunctiva, lacrimal gland, lacrimal sac, or eyelids); (3) Inflammation (such as retinitis, macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis); 6. Eyelid abnormalities affecting eyelid function (such as proptosis, eyelid spasm, ectropion, entropion, severe trichiasis, etc.); 7. Extensive ocular surface scarring or conditions that may compromise ocular surface integrity, such as Stevens-Johnson syndrome, prior chemical burns, recurrent corneal erosion, persistent corneal epithelial defects, previous eye trauma, etc.; 8. Currently diagnosed with glaucoma and undergoing glaucoma medication or surgery; 9. Currently using or planning any specific treatment for dry eye disease; 10. Sodium fluorescein allergy; 11. Pregnant, breastfeeding, or lactating; 12. Neurological or psychiatric disorders (moderate or more anxiety, depression); 13. Uncontrolled ocular or systemic diseases; 14. History of epilepsy; 15. Investigator considers the patient unsuitable for inclusion in this study; 16. Cognitive or mental impairment that prevents giving informed consent or complying with study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| OSDI-12 Score;Fluorescein Tear Film Break-Up Time (BUT); | — |
Countries
China
Contacts
West China Hospital of Sichuan University