Trial Outcomes & Findings for Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease (NCT NCT05486728)
NCT ID: NCT05486728
Last Updated: 2025-10-14
Results Overview
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).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
85 participants
Primary outcome timeframe
Baseline and Day 84
Results posted on
2025-10-14
Participant Flow
Participant milestones
| Measure |
SHJ002
SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days
|
Vehicle
Vehicle: topically administered to each eye BID for 84 days
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
43
|
|
Overall Study
COMPLETED
|
42
|
41
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease
Baseline characteristics by cohort
| Measure |
SHJ002
n=42 Participants
SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days
|
Vehicle
n=43 Participants
Vehicle: topically administered to each eye BID for 84 days
|
Total
n=85 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 15.08 • n=99 Participants
|
45.7 years
STANDARD_DEVIATION 14.28 • n=107 Participants
|
46.3 years
STANDARD_DEVIATION 14.61 • n=206 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
84 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Weight
|
64.30 kg
STANDARD_DEVIATION 10.820 • n=99 Participants
|
63.80 kg
STANDARD_DEVIATION 12.990 • n=107 Participants
|
64.10 kg
STANDARD_DEVIATION 11.900 • n=206 Participants
|
|
Height
|
161.2 cm
STANDARD_DEVIATION 7.77 • n=99 Participants
|
159.7 cm
STANDARD_DEVIATION 8.42 • n=107 Participants
|
160.5 cm
STANDARD_DEVIATION 8.10 • n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 84Population: FAS population
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).
Outcome measures
| Measure |
SHJ002
n=42 Participants
SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days
|
Vehicle
n=43 Participants
Vehicle: topically administered to each eye BID for 84 days
|
|---|---|---|
|
Change From Baseline in Total Corneal Fluorescein Staining (NEI Scale)
|
-2.4 score on a scale
Interval -3.08 to -1.69
|
-1.3 score on a scale
Interval -2.03 to -0.64
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: FAS population
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).
Outcome measures
| Measure |
SHJ002
n=42 Participants
SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days
|
Vehicle
n=43 Participants
Vehicle: topically administered to each eye BID for 84 days
|
|---|---|---|
|
Change From Baseline in SANDE Score
|
-43.9 score on a scale
Interval -49.48 to -38.3
|
-36.0 score on a scale
Interval -41.71 to -30.39
|
SECONDARY outcome
Timeframe: Baseline and Day 84Population: FAS population
100-mm horizontal line from 0 (no discomfort) to 100 (worst discomfort). Reported values represent change from baseline to Day 84.
Outcome measures
| Measure |
SHJ002
n=42 Participants
SHJ002 Ophthalmic Solution: topically administered to each eye BID for 84 days
|
Vehicle
n=43 Participants
Vehicle: topically administered to each eye BID for 84 days
|
|---|---|---|
|
Change From Baseline in Eye Dryness Score (Visual Analogue Scale)
|
-32.0 score on a scale
Interval -38.03 to -25.89
|
-23.3 score on a scale
Interval -29.08 to -17.42
|
Adverse Events
SHJ002
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place