AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dr… (NCT06013436) | Clinical Trial Compass
CompletedNot Applicable
AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye
China30 participantsStarted 2022-06-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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.
What they're measuring
1
cornea nerves
Timeframe: 12 weeks
2
cornea staining score
Timeframe: 4 weeks
Trial details
NCT IDNCT06013436
SponsorChengdu University of Traditional Chinese Medicine