dry eye diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18–70 years (inclusive), both genders. 2. Patients with moderate-to-severe dry eye disease meeting the diagnostic criteria of the Chinese Expert Consensus on Clinical Diagnosis and Treatment of Dry Eye (2024), including corneal damage involving two or more quadrants, and/or corneal fluorescein staining score >=5, tear break-up time (TBUT) <5 seconds, affecting both eyes. 3. Those who voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Planned ocular surgery within 6 months prior to the screening period or during the study period. 2. Pregnant or breastfeeding women. 3. Presence of fungal, viral, or bacterial keratitis or conjunctivitis, or other active ocular surface inflammation. 4. Wearing contact lenses. 5. Current ocular herpes or any other ocular infection, or a history of ocular herpes or any other ocular infection within 30 days prior to screening. 6. Ocular or periorbital allergy, etc. 7. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Corneal fluorescein staining; | — |
Secondary
| Measure | Time frame |
|---|---|
| Tear factors;Tear Secretion Test;tear break-up time;Ocular Surface Disease Index; | — |
Countries
China
Contacts
Eye Hospital, Wenzhou Medical University