This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial.
This study is aSingle-center, multiple-dosing, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of MSCohi-O Lenses in patients with ocular involvement of Sjögren's syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Each subject will wear MSCohi-O Lenses for 12 hours a day, totally 14 wearings.
Adverse events
Incidence and severity of adverse events from subjects receiving administration to Day 29 post-administration.
Time frame: from subjects receiving administration to Day 29 post-administration
corneal fluorescein staining
Changes in corneal fluorescein staining 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
Tear film break-up time
Changes in Tear film break-up time 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
ocular surface disease index scores
Changes in ocular surface disease index 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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