Clinical trial NCT06381986
Conditions: Corneal Erosion
Keywords: Corneal Erosion
Sponsor: Sunhawk Vision Biotech, Inc.
Start date: 2024-06-28; Completion date: 2025-04-17
Enrollment: 116 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to measure efficacy and safety with 0.25% SHJ002 sterile ophthalmic solution compared to vehicle in treating corneal erosion in Sjogren's patients.

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 twice daily for 12 weeks.

Arms: arm 1: SHJ002 Ophthalmic Solution: topically administered to each eye twice daily for 12 weeks arm 2: Vehicle: topically administered to each eye twice daily for 12 weeks
Interventions: intervention 1: SHJ002 intervention 2: Vehicle
Intervention descriptions: intervention 1: Topical ophthalmic intervention 2: Topical ophthalmic

Protocol documents:
Prot_SAP_000.pdf: 
Protocol Synopsis – Public Summary Version 
For: NCT06381986 
A Clinical Study on the Safety and Efficacy of SHJ002 Sterile Ophthalmic Solution in the 
Treatment of Corneal Erosion in Patients with Sjogren’s Syndrome 
 
Sponsor: Sunhawk Vision Biotech, Inc. 
IRB Approval Date: December 16, 2024 
Document Date: December 16, 2024 (Final IRB-approved version: Protocol v2.0, dated 
October 30, 2024) 
 
1. Study Objectives 
Primary Objective: 
To evaluate the efficacy of SHJ002 ophthalmic solution in reducing corneal fluorescein 
staining in patients with corneal erosion secondary to Sjogren’s Syndrome. 
Secondary Objectives: 
To assess changes in regional fluorescein staining (iCFS) and patient-reported symptoms 
using the SANDE questionnaire. 
2. Study Design 
Design: Multicenter, double-blinded, randomized, vehicle-controlled, parallel-group Phase 2 
trial 
Participants: Adults ≥18 years with Sjogren’s Syndrome and corneal erosion 
Randomization: 1:1 ratio to SHJ002 or vehicle group 
Treatment: One drop per eye, twice daily for 12 weeks 
Sites: Multiple hospitals in Taiwan 
3. Endpoints 
Primary Endpoint: 
Change from Baseline to Week 12 in Total Corneal Fluorescein Staining (NEI Scale, score 
range 0–15; higher scores indicate more severe staining) 
Secondary Endpoints: 
- Change in Inferior Corneal Fluorescein Staining (iCFS) Score by NEI Scale (0–3 per region; 
higher scores = worse outcome) 
- Change in Symptom Assessment in Dry Eye (SANDE) score (0–100 scale; higher = worse 
symptoms) 


4. Inclusion / Exclusion Criteria 
Key Inclusion: 
- Adults ≥18 years 
- Diagnosed with Sjogren’s Syndrome and corneal erosion 
- Negative pregnancy test for women of childbearing potential 
 
Key Exclusion: 
- Ocular diseases other than corneal erosion/DED 
- Recent ocular surgery 
- Conflicting medication use or other interfering conditions 
5. Statistical Analysis Overview 
Primary Efficacy Analysis: 
Mixed Model for Repeated Measures (MMRM) used to analyze change in CFS from baseline, 
with covariates including treatment, visit, interaction, and baseline score. 
Reporting: 
Least squares means (LSM), standard error (SE), 95% confidence intervals (CI), and 
treatment group comparisons with p-values. 
Missing Data: 
Assumed Missing at Random (MAR); no imputation was needed. 
 
This is a summary protocol document prepared specifically for 
public registration purposes on ClinicalTrials.gov. Proprietary 
scientific or commercial details have been redacted.