This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial.
This study is a single-center, multiple-dosing, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of exosomes in patients with ocular involvement of Sjögren's syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Each 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: from baseline on Day 8, Day 15 and Day 29 post-administration
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