Clinical trial NCT06717152: Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease
Official title: A Randomized, Double-masked, Parallel, Multicenter, Phase 3 Study to Evaluate the Efficacy and Safety of SJP-0132 Eye Drops Compared With Placebo in Chinese Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Dry Eye
Lead sponsor: Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Senju Pharmaceutical Co., Ltd.
First posted: 2024-12-04
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and efficacy of SJP-0132 in Chinese Patients with Dry Eye.

Patients will be randomly assigned to receive either SJP-0132 or placebo.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged between 18 and 70 at the time of the informed consent
* 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 have previously used SJP-0132 eye drops
* 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
* Meet the other protocol-specified exclusion criteria

Primary outcomes:
measure: Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone
timeFrame: Day 29
measure: Change From Baseline in Eye Dryness Symptom (VAS)
timeFrame: Day 8
Secondary outcomes:
measure: Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone
timeFrame: Day 8, 15, 57
measure: Change From Baseline in Corneal Fluorescein Staining (CFS) Score in Each Zone (central, superior, temporal, nasal, and inferior)
timeFrame: Day 8, 15, 29, 57
measure: Change From Baseline in Conjunctival Fluorescein Staining Score in Each Zone (temporal, temporal superior, temporal inferior, nasal superior, nasal inferior, and nasal)
timeFrame: Day 8, 15, 29, 57
measure: Change From Baseline in Symptoms Score (VAS)
timeFrame: Day 8, 15, 29, 57
measure: Change From Baseline in DEQ-5 Score
timeFrame: Day 29, 57
measure: Change From Baseline in DEQS Score
timeFrame: Day 8, 15, 29, 57
measure: Change From Baseline in Symptom Diary Score
timeFrame: Day 8, 15, 29, 57
measure: Change From Baseline in Tear Film Break-up Time
timeFrame: Day 8, 15, 29, 57
measure: Change From Baseline in Tear Secretion
timeFrame: Day 29, 57
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Xiamen
country: China
facility: Xiamen Eye Center of Xiamen University
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
city: Shantou
country: China
facility: Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Guiyang
country: China
facility: The Affiliated Hospital of Guizhou Medical University
state: Guizhou
city: Zunyi
country: China
facility: Affiliated Hospital of Zunyi Medical University
state: Guizhou
city: Zhengzhou
country: China
facility: Henan Eye Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: People's Hospital of Hunan Province
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Hengyang
country: China
facility: The First Affiliated Hospital of University of South China
state: Hunan
city: Suzhou
country: China
facility: The Fourth Affiliated Hospital of Soochow University
state: Jiangsu
city: Nanchang
country: China
facility: Affiliated Eye Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The Second Norman Bethune Hospital of Jilin University
state: Jilin
city: Dalian
country: China
facility: Dalian No.3 People's Hospital
state: Liaoning
city: Shenyang
country: China
facility: The Fourth People's Hospital of Shenyang
state: Liaoning
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Jinan
country: China
facility: Shandong Eye Hospital
state: Shandong
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital Shanghai University of Traditional Chinese Medicine
state: Shanghai
city: Taiyuan
country: China
facility: Shanxi Eye Hospital
state: Shanxi
city: Xianyang
country: China
facility: The first people's hospital of Xian Yang
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Ophthalmology Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Provincial People's Hospital
state: Zhejiang
city: Ningbo
country: China
facility: Ningbo Eye Hospital
state: Zhejiang
city: Wenzhou
country: China
facility: Eye Hospital, WMU
state: Zhejiang
Study officials:
affiliation: Senju Pharmaceutical Co., Ltd.
name: Kazunori Omatsu
role: STUDY_DIRECTOR
References: