Medium - and long-term efficacy of 0.05% cyclosporine A eye drops in the treatment of dry eye associated with Sjogren's syndrome and consistency of lacrimal gland radionuclide scanning-Single-center, open, randomized controlled study

Medium - and long-term efficacy of 0.05% cyclosporine A eye drops in the treatment of dry eye associated with Sjogren's syndrome and consistency of lacrimal gland radionuclide scanning

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2500111481

Enrollment

Unknown

Registered

2025-10-31

Start date

2021-07-13

Completion date

Unknown

Last updated

2025-11-03

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

Conditions

Dry eye syndrome

Interventions

Mild dry eye control group:Sodium hyaluronate eye drops, tid

Mild dry eye treatment group:0.05% cyclosporine eye drops, bid + sodium hyaluronate eye drops, tid

Moderate dry eye group:0.05% cyclosporine eye drops, tid + sodium hyaluronate eye drops, tid

Severe dry eye group:0.05% cyclosporine eye drops, qid + sodium hyaluronate eye drops, tid

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Ages 18 to 65. 2. The best corrected visual acuity of the study eye was >=0.1. 3. Meet the diagnostic criteria of Sjogren's syndrome. 4. Meet the diagnostic criteria of dry eye.

Exclusion criteria

Exclusion criteria: 1. There was a history of ocular trauma, blepharitis, infection or inflammation unrelated to DED 3 months before the screening visit. 2, exophthalmos or eyelids can not close. 3. Filamentous keratitis. 4. Eye surgery was performed within 3 months before the study. 5. Contact lens wearers. 6. Patients with allergies to the drugs used in the study. 7. Patients must use any systemic or topical drugs that may interfere with the study drugs. 8, serious heart, lung, liver, kidney dysfunction. 9. Pregnant and lactating women. 10. Psychopaths.

Design outcomes

Primary

Measure	Time frame
Ocular surface disease index;Corneal fluorescein staining score;	—

Secondary

Measure	Time frame
Conjunctival hyperemia index;Schirmer I test;breakup time of tear film;	—

Countries

China

Contacts

Public ContactGuigang Li

Tongji Hospital (Tongji Medical College), Huazhong University of Science and Technology

287636449@qq.com+86 186 2728 2957

Outcome results

None listed

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