Efficacy and Safety of SJP-0132 Eye Drops in Chinese Patients With Dry Eye Disease

NCT06717152 | Completed Phase 3

• 2 other identifiers: SJP-0132/3-03CTR20244132
• Study Type: interventional
• Target: 427
• Locations: 1 country
• Sites: 35

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.

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone

  CFS score ranged from 0 to 5, where '0' represents no fluorescein staining, and '5' represents severe staining on the cornea. The higher scores mean worse outcomes.

  Day 29

• Change From Baseline in Eye Dryness Symptom (VAS)

  Visual analog scale (VAS): "0" mean none, and "100" mean the worst imaginable for the symptom question.

  Day 8

Secondary Outcomes (9)

• Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone

  Day 8, 15, 57

• Change From Baseline in Corneal Fluorescein Staining (CFS) Score in Each Zone (central, superior, temporal, nasal, and inferior)

  Day 8, 15, 29, 57

• Change From Baseline in Conjunctival Fluorescein Staining Score in Each Zone (temporal, temporal superior, temporal inferior, nasal superior, nasal inferior, and nasal)

  Day 8, 15, 29, 57

• Change From Baseline in Symptoms Score (VAS)

  Day 8, 15, 29, 57

• Change From Baseline in DEQ-5 Score

  Day 29, 57

Study Arms (2)

SJP-0132

EXPERIMENTAL

The participants receive placebo for 2 weeks in run-in period, then SJP-0132 for 8 weeks in treatment period.

Drug: SJP-0132; Drug: Placebo

Placebo

PLACEBO COMPARATOR

The participants receive placebo for 2 weeks in run-in period, then placebo for 8 weeks in treatment period.

Drug: Placebo

Interventions

SJP-0132 DRUG

Aqueous eye drop, one drop each time and four times each day, 8 weeks in treatment period in SJP-0132 group.

SJP-0132

Placebo DRUG

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; SJP-0132

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd.: lead
• Senju Pharmaceutical Co., Ltd.: collaborator

Study Sites (35)

Beijing Hospital

Beijing, Beijing Municipality, China

Location

Beijing Tongren Hospital

Beijing, Beijing Municipality, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Location

Xiamen Eye Center of Xiamen University

Xiamen, Fujian, China

Location

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

Joint Shantou International Eye Center of Shantou University and the Chinese University of Hong Kong

Shantou, Guangdong, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, China

Location

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

Affiliated Hospital of Zunyi Medical University

Zunyi, Guizhou, China

Location

Henan Eye Hospital

Zhengzhou, Henan, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology

Wuhan, Hubei, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

People's Hospital of Hunan Province

Changsha, Hunan, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, China

Location

The First Affiliated Hospital of University of South China

Hengyang, Hunan, China

Location

The Fourth Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

Location

Affiliated Eye Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

The Second Norman Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

Dalian No.3 People's Hospital

Dalian, Liaoning, China

Location

The Fourth People's Hospital of Shenyang

Shenyang, Liaoning, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Location

Shandong Eye Hospital

Jinan, Shandong, China

Location

Eye & ENT Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Location

Shanxi Eye Hospital

Taiyuan, Shanxi, China

Location

The first people's hospital of Xian Yang

Xianyang, Shanxi, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Location

Tianjin Medical University Ophthalmology Hospital

Tianjin, Tianjin Municipality, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

Ningbo Eye Hospital

Ningbo, Zhejiang, China

Location

Eye Hospital, WMU

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Kazunori Omatsu

  Senju Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: December 4, 2024
• Study Start: December 30, 2024
• Primary Completion: July 28, 2025
• Study Completion: September 1, 2025
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (35)