AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye
- Conditions
- Sjogren's SyndromeDry EyeOcular Surface Disease
- Interventions
- Drug: Autologous serum tears combined with 0.05% cyclosporin eye drop
- Registration Number
- NCT06013436
- Lead Sponsor
- Chengdu University of Traditional Chinese Medicine
- 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 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.
- 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 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Experimental group Autologous serum tears combined with 0.05% cyclosporin eye drop Autologous serum tears, twelve times daily（per hour）, 12weeks. 0.05% cyclosporin eye drop, twice times daily, 12weeks.
- Primary Outcome Measures
Name Time Method cornea nerves 12 weeks cornea sub-basal nerve density
cornea staining score 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 Outcome Measures
Name Time Method Schirmer's test 4 weeks to assess tear flow
Ocular Surface Disease Index (OSDI) 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)
tear film breakup time (TBUT) 4 weeks to assess tear film stability
Trial Locations
- Locations (1)
Hospital of Chengdu University of Traditional Chinese Medicine
🇨🇳Chengdu, Sichuan, China