Corneal Erosion
Conditions
Keywords
Corneal Erosion
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.
Interventions
DRUGSHJ002
Topical ophthalmic
OTHERVehicle
Topical ophthalmic
Sponsors
Sunhawk Vision Biotech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-Blinded, Parallel, Vehicle-Controlled
Intervention model description
Double-Blinded, Parallel, Vehicle-Controlled
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in Total Corneal Fluorescein Staining | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS) | Baseline to Week 12 | iCFS score will be assessed using NEI regional grading (0-3 for the inferior region); higher scores represent more severe staining. |
| Change From Baseline to Week 12 in SANDE Score | Baseline to Week 12 | Symptom Assessment in Dry Eye (SANDE) questionnaire total score, on a 0-100 scale (higher = worse symptoms). |
Countries
Taiwan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SHJ002 SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks | 58 |
| Vehicle Vehicle: topically administered to each eye twice daily for 12 weeks | 58 |
| Total | 116 |
Baseline characteristics
| Characteristic | Vehicle | Total | SHJ002 |
|---|---|---|---|
| Age, Continuous | 61.12 years STANDARD_DEVIATION 10.96 | 61.03 years STANDARD_DEVIATION 10.18 | 60.95 years STANDARD_DEVIATION 9.43 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 58 Participants | 116 Participants | 58 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 55 Participants | 111 Participants | 56 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 58 |
| other Total, other adverse events | 0 / 58 | 0 / 58 |
| serious Total, serious adverse events | 0 / 58 | 0 / 58 |
Outcome results
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).
Time frame: Baseline to Week 12
Population: FAS population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SHJ002 | Change From Baseline to Week 12 in Total Corneal Fluorescein Staining | -2.55 units on a scale |
| Vehicle | Change From Baseline to Week 12 in Total Corneal Fluorescein Staining | -0.37 units on a scale |
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.
Time frame: Baseline to Week 12
Population: FAS population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SHJ002 | Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS) | -0.79 score on a scale |
| Vehicle | Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS) | -0.14 score on a scale |
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).
Time frame: Baseline to Week 12
Population: FAS population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SHJ002 | Change From Baseline to Week 12 in SANDE Score | -31.21 score on a scale |
| Vehicle | Change From Baseline to Week 12 in SANDE Score | -28.87 score on a scale |