A Phase 2 interventional study of SHJ002/Vehicle in Dry Eye Disease, sponsored by Dreamhawk Vision Biotech, Inc.. Completed at 4 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-14.
Sponsored by Dreamhawk Vision Biotech, Inc. · Phase 2, Interventional, and Treatment
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.
Participants will be randomized to treatment with SHJ002 Ophthalmic Solution or vehicle which will be administered to each eye BID for 84 days.
1,292 studies on the registry are indexed under Dry Eye Syndromes; 191 are open to participants now.
This study's enrollment of 85 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →This is the only study on the registry with Dreamhawk Vision Biotech, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days
Drug: SHJ002/Vehicle
Vehicle: topically administered to each eye BID for 84 days
Drug: SHJ002/Vehicle
Topical ophthalmic
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
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
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
| Milestone | SHJ002 | Vehicle |
|---|---|---|
| Started | 42 | 43 |
| Completed | 42 | 41 |
| Not completed | 0 | 2 |
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).
| score on a scale | SHJ002 | Vehicle |
|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale) | -2.4 (-3.08 to -1.69) | -1.3 (-2.03 to -0.64) |
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).
| score on a scale | SHJ002 | Vehicle |
|---|---|---|
| Change From Baseline in SANDE Score | -43.9 (-49.48 to -38.3) | -36.0 (-41.71 to -30.39) |
100-mm horizontal line from 0 (no discomfort) to 100 (worst discomfort). Reported values represent change from baseline to Day 84.
| score on a scale | SHJ002 | Vehicle |
|---|---|---|
| Change From Baseline in Eye Dryness Score (Visual Analogue Scale) | -32.0 (-38.03 to -25.89) | -23.3 (-29.08 to -17.42) |
Collected over 84 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SHJ002 | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Vehicle | 0/43 (0%) | 0/43 (0%) | 0/43 (0%) |
FAS population
| Age, Continuous(years) | SHJ002 | Vehicle | Total |
|---|---|---|---|
| Mean | 46.9 ± 15.08 | 45.7 ± 14.28 | 46.3 ± 14.61 |
| Sex: Female, Male(Participants) | SHJ002 | Vehicle | Total |
|---|---|---|---|
| Female | 29 | 32 | 61 |
| Male | 13 | 11 | 24 |
| Ethnicity (NIH/OMB)(Participants) | SHJ002 | Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 42 | 42 | 84 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Race (NIH/OMB)(Participants) | SHJ002 | Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 40 | 42 | 82 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 2 | 1 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Weight(kg) | SHJ002 | Vehicle | Total |
|---|---|---|---|
| Mean | 64.30 ± 10.820 | 63.80 ± 12.990 | 64.10 ± 11.900 |
| Height(cm) | SHJ002 | Vehicle | Total |
|---|---|---|---|
| Mean | 161.2 ± 7.77 | 159.7 ± 8.42 | 160.5 ± 8.10 |
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