Immune-mediated dry eye
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with immune-mediated dry eye (e.g., Sjögren's syndrome-associated dry eye, rheumatoid arthritis, Stevens-Johnson syndrome, systemic lupus erythematosus, graft-versus-host disease-associated dry eye, etc.) who meet the diagnostic criteria of the International Dry Eye Workshop (DEWS II); 2. Aged 18 to 75 years.
Exclusion criteria
Exclusion criteria: 1. Individuals who have undergone ocular surgery within the past 3 months; 2. Have active ocular infection; 3. Are allergic to any component of the study drug; 4. Are pregnant or breastfeeding; 5. Are currently using other dry eye treatments not specified in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in total corneal fluorescein staining score (tCFS) at Week 12; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in total corneal fluorescein staining score (tCFS) at Week 4;Change from baseline in Ocular Surface Disease Index (OSDI) score at Week 4 and Week 12;Change from baseline in meibomian gland secretion quality, expressibility, lid margin morphology, fluorescein breakup time (FBUT), tear meniscus height, and Schirmer I test at Week 4 and Week 12; | — |
Countries
China
Contacts
Xi'an First Hospital