Trial Outcomes & Findings for Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients (NCT NCT06381986)

NCT ID: NCT06381986

Last Updated: 2025-08-22

Results Overview

The total corneal fluorescein staining score will be assessed using the NEI grading scale (0-15 points; higher scores indicate more severe staining).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 116 participants
• Primary outcome timeframe: Baseline to Week 12
• Results posted on: 2025-08-22

Participant Flow

Participant milestones

Measure	SHJ002 SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks	Vehicle Vehicle: topically administered to each eye twice daily for 12 weeks
Overall Study STARTED	58	58
Overall Study COMPLETED	54	51
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy and Safety of SHJ002 Ophthalmic Solution in the Treatment of Corneal Erosion in Sjogren's Patients

Baseline characteristics by cohort

Measure	SHJ002 n=58 Participants SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks	Vehicle n=58 Participants Vehicle: topically administered to each eye twice daily for 12 weeks	Total n=116 Participants Total of all reporting groups
Age, Continuous	60.95 years STANDARD_DEVIATION 9.43 • n=5 Participants	61.12 years STANDARD_DEVIATION 10.96 • n=7 Participants	61.03 years STANDARD_DEVIATION 10.18 • n=5 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	55 Participants n=7 Participants	111 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	58 Participants n=5 Participants	58 Participants n=7 Participants	116 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Week 12

Population: FAS population

The total corneal fluorescein staining score will be assessed using the NEI grading scale (0-15 points; higher scores indicate more severe staining).

Outcome measures

Measure	SHJ002 n=58 Participants SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks	Vehicle n=58 Participants Vehicle: topically administered to each eye twice daily for 12 weeks
Change From Baseline to Week 12 in Total Corneal Fluorescein Staining	-2.55 units on a scale Interval -3.43 to -1.68	-0.37 units on a scale Interval -1.23 to 0.49

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: FAS population

iCFS score will be assessed using NEI regional grading (0-3 for the inferior region); higher scores represent more severe staining.

Outcome measures

Measure	SHJ002 n=58 Participants SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks	Vehicle n=58 Participants Vehicle: topically administered to each eye twice daily for 12 weeks
Change From Baseline to Week 12 in Inferior Corneal Fluorescein Staining (iCFS)	-0.79 score on a scale Interval -1.07 to -0.52	-0.14 score on a scale Interval -0.41 to 0.13

SECONDARY outcome

Timeframe: Baseline to Week 12

Population: FAS population

Symptom Assessment in Dry Eye (SANDE) questionnaire total score, on a 0-100 scale (higher = worse symptoms).

Outcome measures

Measure	SHJ002 n=58 Participants SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks	Vehicle n=58 Participants Vehicle: topically administered to each eye twice daily for 12 weeks
Change From Baseline to Week 12 in SANDE Score	-31.21 score on a scale Interval -41.21 to -21.21	-28.87 score on a scale Interval -38.15 to -19.59

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

President

Sunhawk Vision Biotech

Phone: +886-72222660

Email: hjuo@shvbiotech.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place