Corneal Erosion Clinical Trial
Official title:
A Clinical Study on the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution in the Treatment of Corneal Erosion in Patients With Sjogren's Syndrome
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.
Status | Not yet recruiting |
Enrollment | 122 |
Est. completion date | February 2025 |
Est. primary completion date | January 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent. 2. Diagnosis with Sjogren's syndrome and have corneal erosion 3. Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test Exclusion Criteria: 1. Ocular surface corneal disease, other than corneal erosion and dry eye disease (DED). 2. Lid margin disorder other than meibomian gland dysfunction (MGD) 3. Presence of any ocular condition 4. Any history of eyelid surgery or intraocular/ocular surgery 5. Cauterization of the punctum or punctal plug 6. Use of lid scrubs containing chemicals or baby shampoo, or eyelid makeup 7. Use of any of the contraindicated drugs medications 8. Any changes in the dosing of any chronically used systemic drug 9. Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol 10. Known history of alcohol and/or drug abuse within 12 months 11. Known allergy or contraindication to any component of investigational product (IP) formulation or diagnostic agents. 12. Participation in any drug or device clinical investigation within 30 days |
Country | Name | City | State |
---|---|---|---|
Taiwan | Kaohsiung Medical Chung-Ho Memorial Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Sunhawk Vision Biotech, Inc. |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To assess the efficacy of SHJ002 sterile ophthalmic solution relative to vehicle as measured by corneal fluorescein staining (CFS) score | Change from Baseline in corneal fluorescein staining (CFS) score | week 12 | |
Secondary | To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by central corneal fluorescein staining (cCFS) score | Change from Baseline in central corneal fluorescein staining (cCFS) score | week 12 | |
Secondary | To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Visual Analogue Scale (VAS) | Visual Analogue Scale (VAS)
100-mm horizontal scale, filled in by participant on the horizontal line from 0 (no discomfort) to 100 (maximal discomfort). |
week 12 | |
Secondary | To assess the efficacy of SHJ002 sterile ophthalmic solution relative to the vehicle as measured by Symptom Assessment in Dry Eye (SANDE) | Symptom Assessment in Dry Eye (SANDE)
The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms |
week 12 |
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