This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.
Aged 18-65 years old, including the boundary value, no gender restriction;
Subjects meeting the 2016 ACR/EULAR classification criteria for Sjögren's syndrome, and also meet the diagnostic criteria for ocular involvement.
The ocular involvement symptoms and signs of these patients cannot be relieved after at least 3 months of conventional therapy, including artificial tears and topical or systemic corticosteroids.
Extra-ocular manifestations of Sjögren's syndrome clinically stable.
Known allergy to any component of the investigational drug.
Active ocular infection.
Presence of other significant ocular disease or trauma diagnosed prior to enrollment, including but not limited to glaucoma, uveitis, retinopathy, chemical injury, or thermal burns.
History of any ocular surgery within the preceding 6 months, including cataract surgery.
Single group
Exosome Preparation
DrugEach subject will have a single designated study eye; this eye will receive multiple instillations-one drop four times daily for 14 consecutive days.
Adverse events (AEs)
Incidence and severity of adverse events (AEs) from subjects receiving administration to Day 29 post-administration.
CFS
Changes in corneal fluorescein staining (CFS) scores from baseline to Day 8, Day 15 and Day 29 post-administration.
TBUT
Changes in Tear film break-up time (TBUT) from baseline on Day 8, Day 15 and Day 29 post-administration.
OSDI
Changes in ocular surface disease index (OSDI) scores from baseline on Day 8, Day 15 and Day 29 post-administration
Schirmer's test
Changes in Schirmer's test from baseline on Day 8, Day 15 and Day 29 post-administration.
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This trial is not recruiting at the moment. You can still explore other options:
