Evaluating SJP-0132 Eye Drops for Dry Eye Disease in Chinese Patients

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

This study is testing if SJP-0132 eye drops can help Chinese patients with dry eye feel better and improve their tear production.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd. (Industry-sponsored)
• Locations: 36 sites (Beijing, Beijing and 35 other locations)
• Trial ID: NCT06717152 on ClinicalTrials.gov

What this trial studies

This clinical trial assesses the safety and efficacy of SJP-0132 eye drops in treating dry eye disease among Chinese patients. Participants will be randomly assigned to receive either the active treatment or a placebo. The study aims to determine if SJP-0132 can improve symptoms and tear film stability in individuals suffering from chronic dry eye. The trial will include outpatient participants aged 18 to 70 with a clinical diagnosis of dry eye.

Who should consider this trial

Good fit: Ideal candidates are male or female patients aged 18 to 70 with a clinical diagnosis of dry eye lasting more than six months.

Not a fit: Patients who have previously used SJP-0132 eye drops or have undergone recent eye surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms of dry eye disease for patients.

How similar studies have performed: Other studies have shown promising results with similar treatments for dry eye disease, indicating potential for success in this approach.

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

Where this trial is running

Beijing, Beijing and 35 other locations

• Beijing Hospital — Beijing, Beijing, China (Recruiting)
• Beijing Tongren Hospital — Beijing, Beijing, China (Recruiting)
• Peking Union Medical College Hospital — Beijing, Beijing, China (Not_yet_recruiting)
• Xiamen Eye Center of Xiamen University — Xiamen, Fujian, China (Recruiting)
• The First Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Zhongshan Ophthalmic Center, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
• Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong — Shantou, Guangdong, China (Recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Recruiting)
• Shenzhen People's Hospital — Shenzhen, Guangdong, China (Recruiting)
• The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China (Recruiting)
• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (Recruiting)
• Henan Eye Hospital — Zhengzhou, Henan, China (Recruiting)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)
• Renmin Hospital of Wuhan University — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China (Not_yet_recruiting)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
• People's Hospital of Hunan Province — Changsha, Hunan, China (Recruiting)
• Xiangya Hospital Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The First Affiliated Hospital of University of South China — Hengyang, Hunan, China (Recruiting)
• The Fourth Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Recruiting)
• Affiliated Eye Hospital of Nanchang University — Nanchang, Jiangxi, China (Recruiting)
• The First Bethune Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• The Second Norman Bethune Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• Dalian No.3 People's Hospital — Dalian, Liaoning, China (Not_yet_recruiting)
• The Fourth People's Hospital of Shenyang — Shenyang, Liaoning, China (Recruiting)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
• Shandong Eye Hospital — Jinan, Shandong, China (Recruiting)
• Eye & ENT Hospital of Fudan University — Shanghai, Shanghai, China (Recruiting)
• Longhua Hospital Shanghai University of Traditional Chinese Medicine — Shanghai, Shanghai, China (Recruiting)
• Shanxi Eye Hospital — Taiyuan, Shanxi, China (Recruiting)
• The first people's hospital of Xian Yang — Xianyang, Shanxi, China (Not_yet_recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
• Tianjin Medical University Ophthalmology Hospital — Tianjin, Tianjin, China (Recruiting)
• Zhejiang Provincial People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Ningbo Eye Hospital — Ningbo, Zhejiang, China (Recruiting)
• Eye Hospital, WMU — Wenzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Kazunori Omatsu

Conditions Dry Eye