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

Chengdu University of Traditional Chinese Medicine

Status: Completed

Conditions: Sjogren's Syndrome; Dry Eye; Ocular Surface Disease

Treatments: Drug: Autologous serum tears combined with 0.05% cyclosporin eye drop

Study type: Observational

Funder types: Other

Identifiers

NCT06013436

22LLZX10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

30 participants in 1 patient group

Experimental group

Description:

Autologous serum tears, twelve times daily（per hour）, 12weeks. 0.05% cyclosporin eye drop, twice times daily, 12weeks.

Treatment:

Drug: Autologous serum tears combined with 0.05% cyclosporin eye drop