The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to vehicle in participants with Dry Eye Disease (DED). SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye BID for 84 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
85
Topical ophthalmic
Australian Eye Specialists
Werribee, Victoria, Australia
Kaohsiung Veterans General Hospital
Kaohsiung City, Kaohsiung, Taiwan
King Chulalongkorn Memorial Hospital
Bangkok, Thailand
Ramathibodi Hospital, Mahidol University
Bangkok, Thailand
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)
NEI Corneal Fluorescein Staining Score (range: 0 to 15, where higher scores indicate worse corneal staining). The score is the sum across five corneal regions (each 0-3).
Time frame: Baseline and Day 84
Change From Baseline in SANDE Score
The SANDE questionnaire assesses dry eye symptoms on a scale from 0 (no symptoms) to 100 (worst symptoms). The reported values represent change from baseline to Day 84 (Day 84 - Baseline).
Time frame: Baseline and Day 84
Change From Baseline in Eye Dryness Score (Visual Analogue Scale)
100-mm horizontal line from 0 (no discomfort) to 100 (worst discomfort). Reported values represent change from baseline to Day 84.
Time frame: Baseline and Day 84
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