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Completed

NCT Number: NCT06013436

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

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 nerves. We assessed the impact of 12-week AST combined with 0.05% cyclosporin eye drop treatment on signs, symptoms, and sub-basal nerve density (SND) in patients with dry eyes related to Sjogren's syndrome.

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Key information

About this study

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 staining with the use of fluorescein, Schirmer's test and corneal confocal microscopy were investigated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous serum tears combined with 0.05% cyclosporin eye drop

Drug

All patients administrated autologous serum tears twelve times daily(per hour) and 0.05% cyclosporin eye drop twice times daily in each eye for 12 weeks.

Other names: Ciclosporin Eye Drops(II)(Cyclone® ,SHENYANG XINGQI PHARMACEUTICAL Co., Ltd.)

Primary outcomes

  1. cornea nerves

    Time frame: 12 weeks

    cornea sub-basal nerve density

  2. cornea staining score

    Time frame: 4 weeks

    to evaluate corneal epithelial repair(0= no staining; 1= less than 5 staining points; 2= more than 5 and less than 30 staining points within the range of two quadrants; and 3= staining exceeding two quadrants or staining points more than 30)

Secondary outcomes

  1. Ocular Surface Disease Index (OSDI)

    Time frame: 4 weeks

    to assess the quality of life and clinical symptom;The survey generated a score ranging 0-100 (0 indicated absence of eye discomfort and 100 represented maximum eye discomfort)

  2. Schirmer's test

    Time frame: 4 weeks

    to assess tear flow

  3. tear film breakup time (TBUT)

    Time frame: 4 weeks

    to assess tear film stability

Sponsors and collaborators

Lead sponsor

Chengdu University of Traditional Chinese Medicine

Other

Registry information

Official study title

Autologous Serum Tears Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With Sjögren's Syndrome Dry Eye

Acronym: AST/SS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2023
Registry last updated
Aug 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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