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
Overview
- Phase
- Phase 2
- Intervention
- SHJ002
- Conditions
- Corneal Erosion
- Sponsor
- Sunhawk Vision Biotech, Inc.
- Enrollment
- 116
- Locations
- 6
- Primary Endpoint
- Change From Baseline to Week 12 in Total Corneal Fluorescein Staining
- Status
- Completed
- Last Updated
- 8 months ago
Overview
Brief Summary
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.
Detailed Description
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye twice daily for 12 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female participants 18 years of age or older inclusive, at the time of signing the informed consent.
- •Diagnosis with Sjogren's syndrome and have corneal erosion
- •Female participants must be 1 year postmenopausal, surgically sterilized, or females of childbearing potential with a negative urine pregnancy test
Exclusion Criteria
- •Ocular surface corneal disease, other than corneal erosion and dry eye disease (DED).
- •Lid margin disorder other than meibomian gland dysfunction (MGD)
- •Presence of any ocular condition
- •Any history of eyelid surgery or intraocular/ocular surgery
- •Cauterization of the punctum or punctal plug
- •Use of lid scrubs containing chemicals or baby shampoo, or eyelid makeup
- •Use of any of the contraindicated drugs medications
- •Any changes in the dosing of any chronically used systemic drug
- •Disease, condition, or disorder that in the judgement of Investigator could confound study assessments or limit compliance to study protocol
- •Known history of alcohol and/or drug abuse within 12 months
Arms & Interventions
SHJ002
SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks
Intervention: SHJ002
Vehicle
Vehicle: topically administered to each eye twice daily for 12 weeks
Intervention: Vehicle
Outcomes
Primary Outcomes
Change From Baseline to Week 12 in Total Corneal Fluorescein Staining
Time Frame: Baseline to Week 12
The total corneal fluorescein staining score will be assessed using the NEI grading scale (0-15 points; higher scores indicate more severe staining).
Secondary Outcomes
- Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS)(Baseline to Week 12)
- Change From Baseline to Week 12 in SANDE Score(Baseline to Week 12)