RecruitingPhase 3NCT06683651

A Study in Chinese Patients With Acquired Blepharoptosis

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


Sponsor

Santen Pharmaceutical Co., Ltd.

Enrollment

180 participants

Start Date

Oct 22, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called STN1013800 ophthalmic solution and a drug called STN1013800 ophthalmic solution Liquid Base, without STN1013800 for people with blepharoptosis. The study is currently recruiting participants at 23 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGSTN1013800 ophthalmic solution

Investigational Product: 0.1% STN1013800 ophthalmic solution

DRUGSTN1013800 ophthalmic solution Liquid Base, without STN1013800

Placebo control: STN1013800 ophthalmic solution Liquid Base, without STN1013800


Locations(23)

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

Nanjing First Hospital

Nanjing, Jiangsu, 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

The affiliated People's Hospital of Ningbo

Zhenjiang, Ningbo, 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

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

Beijing Luhe Hospital, Capital Medical University

Beijing, China

View Full Details on ClinicalTrials.gov

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NCT06683651


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