This is a Phase III Study to evaluate the efficacy and safety of STN1013800 Ophthalmic Solution in Chinese Patients with Acquired Blepharoptosis. At present, there are no medicines for the treatment of acquired blepharoptosis in China. Therefore, to evaluate the efficacy and safety of 0.1% STN1013800 ophthalmic solution, Vehicle (Placebo) are designed. For the screening period, 3-7 days were set to confirm the subjects and judge their qualification. Dosage and administration were based on prior clinical trial results approved at 0.1% once daily for 42 days treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Investigational Product: 0.1% STN1013800 ophthalmic solution
Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800
Anhui Provincial Hospital
Hefei, Anhui, China
RECRUITINGThe Second Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGBeijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGJoint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China
NOT_YET_RECRUITINGAffiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
NOT_YET_RECRUITINGThe first affiliated hospital of Zhengzhou University
Zhengzhou, He'nan, China
RECRUITINGThe 2nd Affiliated Hospital of Harbin Medical University
Ha’erbin, Helongjiang, China
NOT_YET_RECRUITINGWuhan Aier Eye Hospital
Wuhan, Hubei, China
NOT_YET_RECRUITINGXiangyang Central Hospital
Xiangyang, Hubei, China
NOT_YET_RECRUITINGThe second norman bethune hospital of Jilin University
Changchun, Jilin, China
NOT_YET_RECRUITING...and 11 more locations
Mean change from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Mean change from Baseline (Day 1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group in number of points seen in the top 4 rows on the Leicester Peripheral Field Test (LPFT test) at 2 time points
Time frame: Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)
Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Mean change of MRD-1 from Baseline (Day 1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group at 2 time points
Time frame: Day 1 Hour 6 (Visit 2); Day 14 Hour 2 (Visit 3)
Mean change of margin reflex distance-1 (MRD-1) from Baseline in the STN1013800 group versus the Vehicle (Placebo) group
Mean change of MRD-1 from Baseline (Day1, Hour 0) in the STN1013800 group versus the Vehicle (Placebo) group at other timepoints
Time frame: Day 1 at Minute 5, Minute 15, Hour 2; Day 14 at Minute 5, Minute 15, Hour 6; Day 42 at Minute 5, Minute 15
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