Status:
ENROLLING_BY_INVITATION
Efficacy of 0.05% Cyclosporine A Eye Drops Combined With Absorbable Tear Duct Plugs in the Treatment of Dry Eye in Sjögren's Syndrom
Lead Sponsor:
Tianjin Eye Hospital
Conditions:
Dry Eye Disease
Eligibility:
All Genders
Phase:
NA
Brief 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.
Detailed Description
Participants meeting all eligibility criteria were enrolled and randomized to receive combined treatment (0.05% cyclosporine A plus absorbable punctal plug) in one eye and 0.05% cyclosporine A monothe...
Eligibility Criteria
Inclusion
- The patients aged ≥18 years who had a confirmed diagnosis of Sjögren's syndrome (SS).
- 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
- voluntarily participate in this study and sign written informed consent
Exclusion
- Any patient with structural abnormalities (eyelid scars, entropion, trichiasis, etc.);
- Patients with any inflammation or active structural changes in the iris or anterior chamber;
- Glaucoma;
- Patients who have undergone previous ophthalmic surgery or have undergone timely closure;
- Patients using any topical medications other than artificial tears, 0.1% flumirone eye drops, and 0.05% cyclosporine A eye drops;
- Patients who received any systemic or topical antibacterial or anti-inflammatory drug treatment 90 days before the start of the study;
- Patients wearing contact lenses;
- Patients with corneal infection;
- Corneal diseases (marginal ulcers, opacity, scars, bullous keratopathy, conjunctival laxity, eyelid ball adhesions or tumors);
- Pregnancy;
- Study the changes of immunosuppressive system treatment in the first 90 days.
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07171710
Start Date
March 1 2024
End Date
March 31 2026
Last Update
September 12 2025
Active Locations (1)
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1
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China