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| Name | Class |
|---|---|
| ORA, Inc. | INDUSTRY |
| Statistics & Data Corporation | INDUSTRY |
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The purpose of this study is to evaluate the efficacy and safety of SI-614 ophthalmic solution compared with placebo in patients with dry eye
This is a Phase 3, multicenter, randomized, double-masked study designed to evaluate the efficacy and safety of SI-614 ophthalmic solution compared to placebo in patients with dry eye. Approximately 230 male and female patients at least 18 years of age with dry eye in both eyes will be randomized to receive treatment with SI-614 or placebo in a 1:1 ratio.
Randomized subjects received assigned study drug bilaterally four times daily. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SI-614 | Experimental | One drop of study drug was instilled in each eye 4 times daily for 84 days |
|
| Placebo | Placebo Comparator | One drop of study drug was instilled in each eye 4 times daily for 84 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SI-614 | Drug | One drop of study drug was instilled in each eye 4 times daily for 84 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye | The examiner instilled sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. After 3-5 minutes after instillation, the staining was graded with a scale, which was a 0 to 4 scale and where grade 0 = No Staining and 4 = Confluent Staining. Higher numbers indicate worse outcome. The total score was derived using the sum of the 3 regions such that possible scores range from 0 to 12. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis. Analyses were for the study eye only. Efficacy was analyzed on all randomized subjects (232 subjects: 114 subjects in SI-614 and 118 subjects in Placebo). | 29 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Average Score of Ocular Discomfort and Dryness at the Bedtime Assessment From the Patient Daily Diary During Day 1 Through Day 14 | Subjects graded the severity of their dry eye disease symptoms in their diary with rating the severity of 5 symptoms. Each symptom rating ranged from 0 to 5 using whole numbers, where 0 = None and 5 = Worst. Higher numbers indicate worse symptomology. The average score of the two symptoms of ocular discomfort (where 0 = None and 5 = Worst) and dryness (where 0 = None and 5 = Worst) was measured. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George Ousler | ORA, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Research Foundation | Newport Beach | California | 92663 | United States | ||
| Butchertown Clinical Trials |
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Of the screened 470 subjects, 238 subjects were screen failed, and 232 subjects were randomized (114 subjects in SI-614 and 118 subjects in Placebo).
From the 232 subjects, 231 subjects (114 subjects in SI-614, and 117 subjects in Placebo) received at least one dose of study drug and 1 subject did not receive study drug.
Efficacy was analyzed on all randomized subjects (232 subjects). Safety was analyzed on all subjects who receive at least 1 dose of randomized study drug (231 subjects).
This study is a study in which whole participants, not eyes were assigned to Arms/Groups. Patients were randomized to receive treatment with SI-614 or placebo in a 1:1 ratio, and the randomized subjects received assigned study drug bilaterally four times daily. For efficacy endpoints, one "study eye" was defined for each patient at baseline and used for analysis. Therefore, whole patients are assigned to Arms/Groups
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| ID | Title | Description |
|---|---|---|
| FG000 | SI-614 | SI-614: One drop of study drug was instilled in each eye 4 times daily for 84 days |
| FG001 | Placebo | Placebo: One drop of study drug was instilled in each eye 4 times daily for 84 days |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SI-614 | SI-614: One drop of study drug was instilled in each eye 4 times daily for 84 days |
| BG001 | Placebo | Placebo: One drop of study drug was instilled in each eye 4 times daily for 84 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Day 29 in Corneal Fluorescein Staining Score in the Study Eye | The examiner instilled sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. After 3-5 minutes after instillation, the staining was graded with a scale, which was a 0 to 4 scale and where grade 0 = No Staining and 4 = Confluent Staining. Higher numbers indicate worse outcome. The total score was derived using the sum of the 3 regions such that possible scores range from 0 to 12. For efficacy endpoints, one "study eye" were defined for each patient based on the criteria at baseline and used for analysis. Analyses were for the study eye only. Efficacy was analyzed on all randomized subjects (232 subjects: 114 subjects in SI-614 and 118 subjects in Placebo). | Posted | Least Squares Mean | Standard Error | score on a scale | 29 days |
|
84 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SI-614 | One drop of study drug was instilled in each eye 4 times daily for 84 days |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 25.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Instillation site pain | General disorders | MedDRA 25.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| General Manager, Clinical Development Department | Seikagaku Corporation | +81-3-5220-8593 | reply@seikagaku.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 23, 2022 | Aug 21, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 30, 2023 | Aug 21, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Placebo | Drug | One drop of study drug was instilled in each eye 4 times daily for 84 days |
|
|
| 14 days |
| Louisville |
| Kentucky |
| 40206 |
| United States |
| Andover Eye Associates, Inc. | Andover | Massachusetts | 01810 | United States |
| Center for Sight | Henderson | Nevada | 89052 | United States |
| CORE Inc, Vita Eye Clinic | Shelby | North Carolina | 28150 | United States |
| Total Eye Care, PA | Memphis | Tennessee | 38119 | United States |
| Administrative Reasons |
|
| Withdrawal by Subject |
|
| Inclusion Criteria Not Met |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Corneal Fluorescein Staining Score | The examiner instilled sodium fluorescein solution into the inferior conjunctival cul-de-sac of each eye. After 3-5 minutes after instillation, the staining was graded with a scale, which was a 0 to 4 scale and where grade 0 = No Staining and 4 = Confluent Staining. Higher numbers indicate worse outcome. The total score was derived using the sum of the 3 regions such that possible scores range from 0 to 12. Corneal Fluorescein Staining Score were summarized for the study eye. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Placebo | Placebo: One drop of study drug was instilled in each eye 4 times daily for 84 days |
|
|
|
| Secondary | Change From Baseline in the Average Score of Ocular Discomfort and Dryness at the Bedtime Assessment From the Patient Daily Diary During Day 1 Through Day 14 | Subjects graded the severity of their dry eye disease symptoms in their diary with rating the severity of 5 symptoms. Each symptom rating ranged from 0 to 5 using whole numbers, where 0 = None and 5 = Worst. Higher numbers indicate worse symptomology. The average score of the two symptoms of ocular discomfort (where 0 = None and 5 = Worst) and dryness (where 0 = None and 5 = Worst) was measured. | Posted | Least Squares Mean | Standard Error | score on a scale | 14 days |
|
|
|
|
| 0 |
| 114 |
| 4 |
| 114 |
| 31 |
| 114 |
| EG001 | Placebo | One drop of study drug was instilled in each eye 4 times daily for 84 days | 0 | 117 | 3 | 117 | 23 | 117 |
| Cardiac failure congestive | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Cardiac failure | Cardiac disorders | MedDRA 25.0 | Systematic Assessment |
|
| Mental disorder | Psychiatric disorders | MedDRA 25.0 | Systematic Assessment |
|
| Escherichia sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
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| Superior vena cava syndrome | Vascular disorders | MedDRA 25.0 | Systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Metastases to liver | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25.0 | Systematic Assessment |
|
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 25.0 | Systematic Assessment |
|
| Visual acuity reduced | Eye disorders | MedDRA 25.0 | Systematic Assessment |
|
| COVID-19 | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.0 | Systematic Assessment |
|
Investigator must receive prior, written consent from Sponsor before publishing or presenting the results of the Study