The study is being conducted to evaluate the efficacy and safety of SHR8058 eye drops for patients with dry eye disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
312
SHR8058 eye drops
saline eye drops.
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Change from baseline in total Corneal Fluorescein Staining (NEI scale) at Day 57
The National Eye Institute (NEI) scale relies on a chart that divides the cornea into five sections (central, superior, temporal, nasal, and inferior) and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the punctate keratitis, for a maximum total score of 15 points (sum of scores for each section).
Time frame: Baseline, Day 57
Change from baseline in Dryness Score (visual analogue scale [VAS] Severity of Dryness) at Day 57
Study staff will ask participants to rate their severity of ocular dryness (both eyes simultaneously) by placing a vertical mark on a horizontal line to indicate the level of discomfort (0 corresponds to "no dryness" and 100% corresponds to "maximal dryness").
Time frame: Baseline, Day 57
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