Status:
COMPLETED
AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye
Lead Sponsor:
Chengdu University of Traditional Chinese Medicine
Conditions:
Sjogren's Syndrome
Dry Eye
Eligibility:
All Genders
18-65 years
Brief Summary
The objective of the present study was to evaluate the efficacy of autologous serum tears combined with 0.05% cyclosporin eye drop in treating Sjögren's syndrome dry eye and their effect on corneal ne...
Detailed Description
Objective: To describe the clinical efficacy and safety of the treatment of Sjögren's syndrome dry eye using autologous serum tears combined with 0.05% cyclosporin eye drop and to evaluate their effec...
Eligibility Criteria
Inclusion
- Patients were diagnosed with SS according to the classification criteria defined by the American-European Consensus Group for the diagnosis of SS and also diagnosed with severe DED based on the consensus of Chinese dry eye experts.
- Age 18-65 years old.
- Controlled collagen disease by the same rheumatologists at least 3 months prior to the initiation of the trial.
- At least one eye that failed to respond to previous treatments including lartificial tears, topical ocular NSAIDs or corticosteroids.
Exclusion
- Patients with DED related to meibomian gland dysfunction, blepharitis, abnormal blinking, conjunctival relaxation or any other diseases besides SS.
- Diagnosed with allergic conjunctivitis, uveitis, ocular hypertension, retinopathy and other eye diseases.
- Those who have a history of previous ocular oprations, eye injuries or contact lenses usage.
- Known hypersensitivity to experimental drugs or any of its ingredients.
- Necessity to modify the systemic treatment of previous diseases during the trial.
- Pregnancy or lactation.
- Severe systemic disease.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06013436
Start Date
June 1 2022
End Date
June 1 2023
Last Update
August 28 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, China, 610072