Preliminary Study on the Clinical Efficacy and Mechanism of 0.05% Cyclosporine Eye Drops in the Treatment of Sjögren's Syndrome.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500099615

Enrollment

Unknown

Registered

2025-03-26

Start date

2022-03-05

Completion date

Unknown

Last updated

2025-03-31

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

Conditions

Sjögren's Syndrome

Interventions

Experimental group:On top of the existing treatment, add 0.05% cyclosporine eye drops, four times a day.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Aged over 18 years, no gender restriction; 2.Signed written informed consent; 3.Subjects with a history of dry eye disease in both eyes for at least 180 days and diagnosed with Sjögren's syndrome; 4.Currently using artificial tears to treat dry eye-related symptoms; 5.Non-anesthetic tear secretion test (Schirmer I test) = 6; 7.Meibomian gland expression score <= 12 in three locations (inner, middle, and outer) of a single eyelid; 8.Able and willing to participate in all trial assessments and visits as instructed.

Exclusion criteria

Exclusion criteria: 1.Underwent eye surgery (including intraocular, oculoplastic, corneal, or refractive surgery, punctal plug insertion) or experienced eye trauma within six months before the baseline examination; 2.History of intraocular inflammation (e.g., retinitis, uveitis, scleritis, keratitis) within six months before the baseline examination; 3.Other microbial infections of the eye and its adnexa; 4.Eye allergies; 5.Eyelid abnormalities (e.g., entropion, ectropion, tumors, edema, blepharospasm, incomplete eyelid closure, trichiasis, ptosis, dermatochalasis); 6.Dry eye caused by other systemic diseases besides Sjögren's syndrome, such as Stevens-Johnson syndrome, vitamin A deficiency, rheumatoid arthritis, Wegener's granulomatosis, sarcoidosis, leukemia, systemic lupus erythematosus; 7.Unwilling or unable to discontinue the use of medications known to cause dry eye (e.g., antihistamines) at least one month before the baseline examination; 8.Currently using punctal plugs; 9.Nerve paralysis in the pre-treatment area within six months before the baseline examination; 10.Systemic infections or immunosuppressive diseases; 11.Simultaneously participating in other ophthalmic drug or medical device clinical trials; 12.Pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
Break-Up Time(BUT);Corneal fluorescein staining score;	—

Secondary

Measure	Time frame
Schirmer test;Meibomian gland dropout(MGd);Examination of eyelid margin score;Tear inflammatory factors;confocal microscopy related indicators;	—

Countries

China

Contacts

Public ContactWenjing Song

Peking University First Hospital

songwenjing@pku.edu.cn+86 156 0056 1996

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 13, 2026