At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 85 enrolled
Drug / intervention
SHJ002/Vehicledrug
Likely dose
Not stated in record
Key inclusion· 3
- ✓Age ≥18 years at informed consent
- ✓Diagnosis of DED in both eyes for at least 6 months
- ✓Female participants must be postmenopausal (≥1 year), surgically sterilized, or of childbearing potential with negative urine pregnancy test
Key exclusion· 11
- ✕Ocular surface disease other than DED
- ✕Eyelid margin disorder other than meibomian gland dysfunction (MGD)
- ✕Any ocular condition
- ✕History of eyelid surgery or intraocular/ocular surgery
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease
In Brief
A Phase 2 clinical trial evaluating SHJ002/Vehicle for Dry Eye Disease. Completed, enrolled 85 participants across 4 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Disease
CountriesAustralia, Taiwan, Thailand
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedAug 2022
Enrollment StartFeb 2023
Primary CompletionDec 2023
TodayJul 2026
First PostedAug 4, 2022
Enrollment StartFeb 8, 2023
Primary CompletionDec 7, 2023
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 3.9 years ago
Interventions
SHJ002/Vehicledrug
Topical ophthalmic