Dry Eye Disease
Conditions
Keywords
Dry Eye Disease
Brief summary
The purpose of this study is to measure efficacy and safety with SHJ002 sterile ophthalmic solution compared to vehicle in participants with Dry Eye Disease (DED). 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 BID for 84 days.
Interventions
DRUGSHJ002/Vehicle
Topical ophthalmic
Sponsors
Dreamhawk Vision Biotech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
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. Have DED in both eyes for ≥ 6 months 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 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 eye 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 in Total Corneal Fluorescein Staining (NEI Scale) | Baseline and Day 84 | NEI Corneal Fluorescein Staining Score (range: 0 to 15, where higher scores indicate worse corneal staining). The score is the sum across five corneal regions (each 0-3). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Eye Dryness Score (Visual Analogue Scale) | Baseline and Day 84 | 100-mm horizontal line from 0 (no discomfort) to 100 (worst discomfort). Reported values represent change from baseline to Day 84. |
| Change From Baseline in SANDE Score | Baseline and Day 84 | The SANDE questionnaire assesses dry eye symptoms on a scale from 0 (no symptoms) to 100 (worst symptoms). The reported values represent change from baseline to Day 84 (Day 84 - Baseline). |
Countries
Australia, Taiwan, Thailand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SHJ002 SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days | 42 |
| Vehicle Vehicle: topically administered to each eye BID for 84 days | 43 |
| Total | 85 |
Baseline characteristics
| Characteristic | SHJ002 | Vehicle | Total |
|---|---|---|---|
| Age, Continuous | 46.9 years STANDARD_DEVIATION 15.08 | 45.7 years STANDARD_DEVIATION 14.28 | 46.3 years STANDARD_DEVIATION 14.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 42 Participants | 84 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Height | 161.2 cm STANDARD_DEVIATION 7.77 | 159.7 cm STANDARD_DEVIATION 8.42 | 160.5 cm STANDARD_DEVIATION 8.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 40 Participants | 42 Participants | 82 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 | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 61 Participants |
| Sex: Female, Male Male | 13 Participants | 11 Participants | 24 Participants |
| Weight | 64.30 kg STANDARD_DEVIATION 10.82 | 63.80 kg STANDARD_DEVIATION 12.99 | 64.10 kg STANDARD_DEVIATION 11.9 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 43 |
| other Total, other adverse events | 0 / 42 | 0 / 43 |
| serious Total, serious adverse events | 0 / 42 | 0 / 43 |
Outcome results
Primary
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)
NEI Corneal Fluorescein Staining Score (range: 0 to 15, where higher scores indicate worse corneal staining). The score is the sum across five corneal regions (each 0-3).
Time frame: Baseline and Day 84
Population: FAS population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SHJ002 | Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) | -2.4 score on a scale |
| Vehicle | Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) | -1.3 score on a scale |
Secondary
Change From Baseline in Eye Dryness Score (Visual Analogue Scale)
100-mm horizontal line from 0 (no discomfort) to 100 (worst discomfort). Reported values represent change from baseline to Day 84.
Time frame: Baseline and Day 84
Population: FAS population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SHJ002 | Change From Baseline in Eye Dryness Score (Visual Analogue Scale) | -32.0 score on a scale |
| Vehicle | Change From Baseline in Eye Dryness Score (Visual Analogue Scale) | -23.3 score on a scale |
Secondary
Change From Baseline in SANDE Score
The SANDE questionnaire assesses dry eye symptoms on a scale from 0 (no symptoms) to 100 (worst symptoms). The reported values represent change from baseline to Day 84 (Day 84 - Baseline).
Time frame: Baseline and Day 84
Population: FAS population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| SHJ002 | Change From Baseline in SANDE Score | -43.9 score on a scale |
| Vehicle | Change From Baseline in SANDE Score | -36.0 score on a scale |