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Search / Trial NCT06013436

AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye

Launched by CHENGDU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Aug 25, 2023

Trial Information

Current as of July 08, 2025

Completed

Keywords

Autologous Serum Tears 0.05% Cyclosporin Eye Drop Cornea Nerves

ClinConnect Summary

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 effect on corneal nerves.

Design: Singal-center, prospective, observational study. Patients and methods: Thirty eyes of fifteen patients with dry eye related to Sjögren syndrome were enrolled in this study. Following a 4-week washout period, the treatment was inverted for each patient for the same duration and treatment. Ocular Surface Disease Index (OSDI), tear film, break-up time, corneal stainin...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About Chengdu University Of Traditional Chinese Medicine

Chengdu University of Traditional Chinese Medicine (CUTCM) is a prominent academic institution dedicated to the research and advancement of Traditional Chinese Medicine (TCM). Renowned for its rigorous educational programs and innovative research initiatives, CUTCM actively contributes to the integration of TCM with modern medical practices. The university emphasizes evidence-based research, aiming to validate and enhance traditional therapeutic methods through clinical trials and scientific inquiry. With a commitment to improving healthcare outcomes, CUTCM collaborates with various stakeholders to explore the efficacy and safety of TCM interventions, fostering a deeper understanding of holistic health approaches.

Locations

Chengdu, Sichuan, China

Patients applied

0 patients applied

Trial Officials

Jiachun Hu, Resident

Principal Investigator

Hospital of Chengdu University of Traditional Chinese Medicine

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported