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A Study in Chinese Patients With Acquired Blepharoptosis
Sponsor: Santen Pharmaceutical Co., Ltd.
Summary
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.
Official title: A Multicenter, Randomized, Double-Masked, Placebo-Controlled Parallel Group Phase III Study to Evaluate the Efficacy and Safety of STN1013800 Ophthalmic Solution in Chinese Patients With Acquired Blepharoptosis
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
180
Start Date
2024-10-22
Completion Date
2026-06
Last Updated
2024-11-12
Healthy Volunteers
No
Conditions
Interventions
STN1013800 ophthalmic solution
Investigational Product: 0.1% STN1013800 ophthalmic solution
STN1013800 ophthalmic solution Liquid Base, without STN1013800
Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800
Locations (21)
Anhui Provincial Hospital
Hefei, Anhui, China
The Second Hospital of Anhui Medical University
Hefei, Anhui, China
Beijing Chaoyang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
The first affiliated hospital of Zhengzhou University
Zhengzhou, He'nan, China
The 2nd Affiliated Hospital of Harbin Medical University
Ha’erbin, Helongjiang, China
Wuhan Aier Eye Hospital
Wuhan, Hubei, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The second norman bethune hospital of Jilin University
Changchun, Jilin, China
Dalian No.3 Peple's Hospital
Dali, Liaoning, China
The 4TH People's Hospital of Shenyang
Shenyang, Liaoning, China
Shandong Eye Hospital
Jinan, Shandong, China
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
Panzhihua Hospital of Integrated Chinese and Western Medicine
Panzhihua, Sichuan, China
Tianjin Eye Hospital
Tianjin, Tianjin Municipality, China
Tianjin Medical University Eye Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Eye Hospital, Wenzhou Medical University / Zhejiang Eye Hospital
Wenzhou, Zhejiang, China