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The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.
SHJ002 is an antisense oligonucleotide to neutralize a specific microRNA.
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye twice daily for 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHJ002 | Experimental | SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks |
|
| Vehicle | Placebo Comparator | Vehicle: topically administered to each eye twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHJ002 | Drug | Topical ophthalmic |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Total Corneal Fluorescein Staining | The total corneal fluorescein staining score will be assessed using the NEI grading scale (0-15 points; higher scores indicate more severe staining). | Baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS) | iCFS score will be assessed using NEI regional grading (0-3 for the inferior region); higher scores represent more severe staining. | Baseline to Week 12 |
| Change From Baseline to Week 12 in SANDE Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical Chung-Ho Memorial Hospital | Kaohsiung City | 807 | Taiwan | |||
| Kaohsiung Veterans General Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | SHJ002 | SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks |
| FG001 | Vehicle | Vehicle: topically administered to each eye twice daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SHJ002 | SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks |
| BG001 | Vehicle | Vehicle: topically administered to each eye twice daily for 12 weeks |
| 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 Week 12 in Total Corneal Fluorescein Staining | The total corneal fluorescein staining score will be assessed using the NEI grading scale (0-15 points; higher scores indicate more severe staining). | FAS population | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | Baseline to Week 12 |
|
84 Days
Treatment-emergent adverse event
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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 | SHJ002 | SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| President | Sunhawk Vision Biotech | +886-72222660 | hjuo@shvbiotech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 16, 2024 | Aug 5, 2025 | Prot_SAP_000.pdf |
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Double-Blinded, Parallel, Vehicle-Controlled
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Double-Blinded, Parallel, Vehicle-Controlled
| Other |
Topical ophthalmic |
|
Symptom Assessment in Dry Eye (SANDE) questionnaire total score, on a 0-100 scale (higher = worse symptoms). |
| Baseline to Week 12 |
| Kaohsiung City |
| 81341 |
| Taiwan |
| Chang Gung Memorial Hospital-Tu Cheng | New Taipei City | 236 | Taiwan |
| MacKay Memorial Hospital | Taipei | 10449 | Taiwan |
| Cathay General Hospital | Taipei | 106 | Taiwan |
| Tri-Service General Hospital | Taipei | 11490 | Taiwan |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS) | iCFS score will be assessed using NEI regional grading (0-3 for the inferior region); higher scores represent more severe staining. | FAS population | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to Week 12 |
|
|
|
| Secondary | Change From Baseline to Week 12 in SANDE Score | Symptom Assessment in Dry Eye (SANDE) questionnaire total score, on a 0-100 scale (higher = worse symptoms). | FAS population | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Baseline to Week 12 |
|
|
|
| 0 |
| 58 |
| 0 |
| 58 |
| 0 |
| 58 |
| EG001 | Vehicle | Vehicle: topically administered to each eye twice daily for 12 weeks | 0 | 58 | 0 | 58 | 0 | 58 |
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