0.05% Cyclosporine Eye Drops: Cyclosporin A 0.05% eye drops were administered twice daily to both eyes
Smart plug absorbable lacrimal duct plugs: The lacrimal duct embolization implant is performed by partially sealing the tear discharge duct to increase the lubrication of natural tears on the eye surface.
Study summary
To study the effectiveness of 0.05% cyclosporine A eye drops in combination with smart plug absorbable lacrimal duct plugs in the monotherapy of cyclosporine for SSDE.
Eligibility
Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. The patients aged ≥18 years who had a confirmed diagnosis of Sjögren's syndrome (SS).
2. Dry eye diagnosis required both subjective and objective criteria: participants presented with one or more ocular surface symptoms such as dryness, foreign body sensation, burning, fatigue, discomfort, redness, or fluctuating vision, with an Ocular Surface Disease Index (OSDI) score of ≥13; Noninvasive Tear Break-Up Time (NIBUT)≤10s and Schirmer I test≤ 5 mm/5 min
3. voluntarily participate in this study and sign written informed consent
Exclusion Criteria:
1. Any patient with structural abnormalities (eyelid scars, entropion, trichiasis, etc.);
2. Patients with any inflammation or active structural changes in the iris or anterior chamber;
3. Glaucoma;
4. Patients who have undergone previous ophthalmic surgery or have undergone timely closure;
5. Patients using any topical medications other than artificial tears, 0.1% flumirone eye drops, and 0.05% cyclosporine A eye drops;
6. Patients who received any systemic or topical antibacterial or anti-inflammatory drug treatment 90 days before the start of the study;
7. Patients wearing contact lenses;
8. Patients with corneal infection;
9. Corneal diseases (marginal ulcers, opacity, scars, bullous keratopathy, conjunctival laxity, eyelid ball adhesions or tumors);
10. Pregnancy;
11. Study the changes of immunosuppressive system treatment in the first 90 days.
Primary outcome measure(s)
The Ocular Surface Disease Index (OSDI) score — Assessed after 3 months of the trial The Ocular Surface Disease Index (OSDI) is a tool used for screening and diagnosing patients with dry eye syndrome. It assesses the severity of dry eye, covering three dimensions: ocular symptoms, visual function and environmental triggers
VAS score — Assessed after 3 months of the trial A swimming ruler of about 10cm in length was used, with 10 scales on one side and "0" and "10" ends, respectively, with 0 indicating no pain and 10 indicating the most severe pain that was unbearable.
BUT — Assessed after 6 months of the trial Tear film break-up time,It is a tear stability test
tear river height — Assessed after 6 months of the trial The concave arc formed at the junction of tears and eyelid margin was observed under a slit lamp microscope, and the tear secretion was indirectly evaluated by measuring the tear retention height
IVCM examination — Assessed after 6 months of the trial It can observe the physiological and pathological changes of ocular surface tissues and cell structures in vivo, and has wide applications in the diagnosis and treatment evaluation of infectious keratitis, ocular surface assessment of dry eye disease, evaluation of the therapeutic effect of ocular surface surgery, and early screening of diabetes.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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