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Dry EyePhase 3NCT06717152

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

A Phase 3 study testing SJP-0132 in people with Dry Eye, run by Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd. at 35 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Dry Eye
What is being tested?
SJP-0132
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
427 participants
Where
35 sitesChina
Study dates
30 Dec 2024to 1 Sep 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Beijing Tongren Hospital

    Beijing, Beijing Municipality

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

  • The Second Norman Bethune Hospital of Jilin University

    Changchun, Jilin

  • People's Hospital of Hunan Province

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Dalian No.3 People's Hospital

    Dalian, Liaoning

  • Zhongshan Ophthalmic Center, Sun Yat-sen University

    Guangzhou, Guangdong

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

  • The First Affiliated Hospital of University of South China

    Hengyang, Hunan

  • Shandong Eye Hospital

    Jinan, Shandong

  • Affiliated Eye Hospital of Nanchang University

    Nanchang, Jiangxi

  • Ningbo Eye Hospital

    Ningbo, Zhejiang

  • Eye & ENT Hospital of Fudan University

    Shanghai, Shanghai Municipality

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai, Shanghai Municipality

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

    Shantou, Guangdong

  • The Fourth People's Hospital of Shenyang

    Shenyang, Liaoning

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • The Fourth Affiliated Hospital of Soochow University

    Suzhou, Jiangsu

  • Shanxi Eye Hospital

    Taiyuan, Shanxi

  • Tianjin Medical University Ophthalmology Hospital

    Tianjin, Tianjin Municipality

  • Eye Hospital, WMU

    Wenzhou, Zhejiang

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

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

    Wuhan, Hubei

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

  • Xiamen Eye Center of Xiamen University

    Xiamen, Fujian

  • The first people's hospital of Xian Yang

    Xianyang, Shanxi

  • Henan Eye Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou

Other trials in China

About this study

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

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
Being tested
SJP-0132, Placebo
Medical subject headings
Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SJP-0132Drug

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

  • PlaceboDrug

    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.

Study groups in NCT06717152
Study groupRoleWhat they receive
SJP-0132ExperimentalThe participants receive placebo for 2 weeks in run-in period, then SJP-0132 for 8 weeks in treatment period.
Receives: Drug: SJP-0132; Drug: Placebo
PlaceboPlacebo comparatorThe participants receive placebo for 2 weeks in run-in period, then placebo for 8 weeks in treatment period.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 29

  2. 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.

    Measured: Day 8

Secondary outcomes (9)

  1. 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.

    Measured: Day 8, 15, 57

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

    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.

    Measured: Day 8, 15, 29, 57

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

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

    Measured: Day 8, 15, 29, 57

  4. Change From Baseline in Symptoms Score (VAS)

    Visual analog scale (VAS): "0" mean none, and "100" mean the worst imaginable for the symptom question. VAS of Eye Dryness Symptom on Day 8 is excluded.

    Measured: Day 8, 15, 29, 57

  5. Change From Baseline in DEQ-5 Score

    The participants rated the frequency on a scale of 0 (never) to 4 (constant) with which they have experienced 3 symptoms (watery eyes, discomfort and dryness). The participant was also asked to rate the intensity of discomfort and dryness on a scale of 0 (never have it) to 5 (very intense). Total DEQ-5 score was the sum of scores for frequency and intensity of dryness and discomfort plus frequency of watery eyes. Maximum score is 22. Higher scores mean a worse outcome.

    Measured: Day 29, 57

  6. Change From Baseline in DEQS Score

    The DEQS score is composed of three categories of questions: questions about eye symptoms (6 questions), questions about the impact on daily life (9 questions), and question on general status (1 question). The questions regarding eye symptoms and the impact on daily life are scored in terms of their frequency and degree. The frequency is rated on a scale of 0 (never) to 4 (always) and the degree on a scale of 1 [hardly bothered me (not very bothersome)] to 4 [bothered me very much (very bothersome)]. The overall assessment is given on a scale of 1 (extremely good) to 6 (extremely bad). Maximum score is 100. The higher the score, the more severe the subjective symptoms of dry eye.

    Measured: Day 8, 15, 29, 57

  7. Change From Baseline in Symptom Diary Score

    The participants self-assess their dry eye symptoms using a diary. The scores are divided into several levels, ranging from 'not bothersome' to 'very troublesome,' with higher levels indicating worse symptoms.

    Measured: Day 8, 15, 29, 57

  8. Change From Baseline in Tear Film Break-up Time

    Tear film break-up time is the time taken for the first dry spot to appear on the cornea after a complete blink.

    Measured: Day 8, 15, 29, 57

  9. Change From Baseline in Tear Secretion

    The Schirmer's Test I method is used to measure tear secretion. The amount of tear secretion for 5 minutes is measured with a graduated Schirmer's test strip without topical ocular anesthetics. The longer the wetted portion of the test strip, the higher the tear secretion.

    Measured: Day 29, 57

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start30 Dec 2024
  3. Primary completion28 Jul 2025
  4. Study completion1 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
427 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06717152
Sponsor's protocol ID
SJP-0132/3-03
Other IDs
CTR20244132
Status last verified
Nov 2025
First submitted
1 Dec 2024
Last updated
26 Nov 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SJP-0132 in people with Dry Eye, run by Senju Pharmaceutical Science & Technology (Beijing) Co., Ltd. at 35 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone (time frame: Day 29). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06717152.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.

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