A Clinical Multi-center Study of Safety and Efficacy of Tacrolimus Eye Drops in Sjogren's Syndrome Dry Eye

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-17013772

Enrollment

Unknown

Registered

2017-12-08

Start date

2018-01-01

Completion date

Unknown

Last updated

2017-12-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sjogren's Syndrome Dry Eye

Interventions

group of tacrolimus eye drops:tacrolimus eye drops

group of flurometholone eye drops:flurometholone eye drops

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged=18 years; 2. Sjogrens syndrome (SS) was diagnosed according to the SS European Criteria; 3 moderate to severe dry eye; (1) eye dryness score (EDS) = 40 (VAS, 0-100); (2) BUT = 5s; (3) Schirmer I test (anesthesia) = 5mm/5min; (4) corneal fluorescein staining score (CFS) = 2 in any zone of cornea, CFS = 2 in central cornea and CFS = 1 in inferior cornea.

Exclusion criteria

Exclusion criteria: 1) any structural abnormalities (lid scarring, entropion, trichiasis, etc.); 2) glaucoma; 3) contact lens wearer; 4) intraocular surgery within 12months; 5) ocular infection; 6) current use of systemic immunosuppressants or large doses of steriods; 7) pregnant or lactating women.

Design outcomes

Primary

Measure	Time frame
eye dryness score (EDS);	—

Secondary

Measure	Time frame
Ocular Surface Disease Index (OSDI);BUT;corneal fluorescein staining;Schirmer I test;intraocular pressure (IOP);	—

Countries

China

Contacts

Public ContactWei Chen

The Eye Hospital of Wenzhou Medical University

chenweimd@hotmail.com+86 13757728118

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026