Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease
NCT ID: NCT06717152
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
427 participants
INTERVENTIONAL
2024-12-30
2025-09-01
Brief Summary
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Patients will be randomly assigned to receive either SJP-0132 or placebo.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SJP-0132
The participants receive placebo for 2 weeks in run-in period, then SJP-0132 for 8 weeks in treatment period.
SJP-0132
Aqueous eye drop, one drop each time and four times each day, 8 weeks in treatment period in SJP-0132 group.
Placebo
Aqueous eye drop, one drop each time and four times each day, 2 weeks in run-in period in both groups and 8 weeks in treatment period in placebo group.
Placebo
The participants receive placebo for 2 weeks in run-in period, then placebo for 8 weeks in treatment period.
Placebo
Aqueous eye drop, one drop each time and four times each day, 2 weeks in run-in period in both groups and 8 weeks in treatment period in placebo group.
Interventions
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SJP-0132
Aqueous eye drop, one drop each time and four times each day, 8 weeks in treatment period in SJP-0132 group.
Placebo
Aqueous eye drop, one drop each time and four times each day, 2 weeks in run-in period in both groups and 8 weeks in treatment period in placebo group.
Eligibility Criteria
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Inclusion Criteria
* Outpatient patients
* The patient's self-described dry eye symptom is more than 6 months or has the clinical diagnosis certificate of dry eye in the past 6 months at the time of the informed consent
* Tear film break-up time of \<= 5 seconds at the beginning of screening and treatment period
Exclusion Criteria
* Patients who participated in or are currently participating in or planned to participate in other clinical studies within three months prior to the start of the screening period
* Patients who plan to wear corneal contact lenses between the beginning of the screening period and the end of the treatment period
* Patients who have undergone eye surgery (including laser surgery) or planned to undergo any eye surgery during the study period within one year prior to the beginning of the corneal transplantation surgery or screening period
* Any ophthalmic disease except for the dry eye (including eyeball or periocular infection, allergic or proliferative eye disease) is present at the beginning of the screening period and at the beginning of the treatment period. However, it does not include chronic eye disease patients who do not need treatment and may not become worse before the end of the treatment period
* Have known history of hypersensitivity or serious adverse reaction to any of the study drug ingredients
* Patients suffering from serious cardiovascular, respiratory, endocrine, digestive, urinary, blood, neurological, mental, ocular or peripheral malignancies (cured in or at the beginning of the screening period but not exceeding five years), at the beginning of screening and treatment period
* A patient at the beginning of screening and at treatment period who has a positive blood serum pregnancy test result or is in lactation, or a female patient who has planned pregnancy during the study period or has fertility but is unable to use effective contraception during the study period, or a female partner of a male patient who is unable to use effective contraception during the study
* Patients identified at the beginning of screening and treatment period as researchers, research coordinators, researchers and immediate relatives of the persons referred to above
* At the beginning of the screening and treatment period, investigators determine that patients who were unable to comply with the requirements of the program or were unable to come to hospital on schedule (e.g. patients who planned to travel or stay in the field during the period prior to the end of the treatment period)
* At the beginning of the screening and treatment period, investigators decide that the patients who were not suitable for the trial were not suitable for the other reasons
18 Years
70 Years
ALL
No
Sponsors
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Senju Pharmaceutical Co., Ltd.
INDUSTRY
Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Kazunori Omatsu
Role: STUDY_DIRECTOR
Senju Pharmaceutical Co., Ltd.
Locations
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Beijing Hospital
Beijing, Beijing Municipality, China
Beijing Tongren Hospital
Beijing, Beijing Municipality, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Xiamen Eye Center of Xiamen University
Xiamen, Fujian, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China
Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
Shantou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Henan Eye Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Renmin Hospital of Wuhan University
Wuhan, Hubei, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
People's Hospital of Hunan Province
Changsha, Hunan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China
The Fourth Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Eye Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
The Second Norman Bethune Hospital of Jilin University
Changchun, Jilin, China
Dalian No.3 People's Hospital
Dalian, Liaoning, China
The Fourth People's Hospital of Shenyang
Shenyang, Liaoning, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China
Shandong Eye Hospital
Jinan, Shandong, China
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Longhua Hospital Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China
Shanxi Eye Hospital
Taiyuan, Shanxi, China
The first people's hospital of Xian Yang
Xianyang, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Medical University Ophthalmology Hospital
Tianjin, Tianjin Municipality, China
Zhejiang Provincial People's Hospital
Hangzhou, Zhejiang, China
Ningbo Eye Hospital
Ningbo, Zhejiang, China
Eye Hospital, WMU
Wenzhou, Zhejiang, China
Countries
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Other Identifiers
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CTR20244132
Identifier Type: REGISTRY
Identifier Source: secondary_id
SJP-0132/3-03
Identifier Type: -
Identifier Source: org_study_id
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