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| ID | Type | Description | Link |
|---|---|---|---|
| CTR20244132 | Registry Identifier | Chinadrugtrials |
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| Name | Class |
|---|---|
| Senju Pharmaceutical Co., Ltd. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SJP-0132 | Experimental | The participants receive placebo for 2 weeks in run-in period, then SJP-0132 for 8 weeks in treatment period. |
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| Placebo | Placebo Comparator | The participants receive placebo for 2 weeks in run-in period, then placebo for 8 weeks in treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SJP-0132 | Drug | Aqueous eye drop, one drop each time and four times each day, 8 weeks in treatment period in SJP-0132 group. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 8, 15, 57 |
| Change From Baseline in Corneal Fluorescein Staining (CFS) Score in Each Zone (central, superior, temporal, nasal, and inferior) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazunori Omatsu | Senju Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Beijing | Beijing Municipality | China | |||
| Beijing Tongren Hospital |
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| 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. |
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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 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) | 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. | Day 8, 15, 29, 57 |
| 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. | Day 8, 15, 29, 57 |
| 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. | Day 29, 57 |
| 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. | Day 8, 15, 29, 57 |
| 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. | Day 8, 15, 29, 57 |
| 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. | Day 8, 15, 29, 57 |
| 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. | Day 29, 57 |
| 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 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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