Trials / Completed
CompletedNCT05486728
Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
A Double-Blinded, Parallel, Vehicle-Controlled Phase 2 Study of SHJ002 Sterile Ophthalmic Solution in Participants With Dry Eye Disease
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Dreamhawk Vision Biotech, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SHJ002/Vehicle | Topical ophthalmic |
Timeline
- Start date
- 2023-02-08
- Primary completion
- 2023-12-07
- Completion
- 2023-12-07
- First posted
- 2022-08-04
- Last updated
- 2025-10-14
- Results posted
- 2025-10-14
Locations
4 sites across 3 countries: Australia, Taiwan, Thailand
Source: ClinicalTrials.gov record NCT05486728. Inclusion in this directory is not an endorsement.