Back to resultsPhase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
Primary Purpose
Myopia
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
SHJ - Low concentration
SHJ - Mid concentration
SHJ - High concentration
SHJ - Maximum tolerated
Sponsored by
About this trial
This is an interventional treatment trial for Myopia focused on measuring Myopia
Eligibility Criteria
Inclusion Criteria:
- Non-cycloplegic sphere from +1.50 to -4.75 Diopters in one or both eyes.
- A minor able to complete all study assessments and comply with the protocol and has a parent or caregiver willing and able to follow study instructions, comply with the protocol and attend study visits with the subject as required, in the opinion of the Investigator.
- Literate and able to orally communicate.
Exclusion Criteria:
- Non-cycloplegic sphere worse than -4.75 Diopters
- Axial length > 26 mm
- Hyperopia worse than +1.50 Diopters
- Anisometropia (difference of myopic power >2.00 D).
- Astigmatism > 1.5 D.
- Intraocular pressure > 21 mm Hg or < 6 mm Hg.
Sites / Locations
- Kaohsiung Veterans General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
0.025% SHJ002
0.080% SHJ002
0.25% SHJ002
SHJ002 - Maximum tolerated concentration
Arm Description
0.025% SHJ002 Sterile Ophthalmic Solution
0.080% SHJ002 Sterile Ophthalmic Solution
0.25% SHJ002 Sterile Ophthalmic Solution
Maximum tolerated concentration of SHJ002
Outcomes
Primary Outcome Measures
Change from baseline in best corrected visual acuity
Change from baseline in best corrected visual acuity
Incidence of Adverse Events
Incidence of Adverse Events
Secondary Outcome Measures
Full Information
NCT ID
NCT04928144
First Posted
June 9, 2021
Last Updated
March 21, 2022
Sponsor
Sunhawk Vision Biotech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04928144
Brief Title
Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
Official Title
An Intra-subject Dose Escalation Phase 1 Study to Determine the Safety and Tolerability of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
July 2, 2021 (Actual)
Primary Completion Date
September 17, 2021 (Actual)
Study Completion Date
September 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunhawk Vision Biotech, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a single-center, open-label, first-in-human dose-escalation study of SHJ002 Ophthalmic Solution in children. (Part 1) Three (3) subjects will receive each concentration of SHJ002 for 3 days in an escalation design in one eye. (Part 2) A Group of 9 additional children will receive the highest tolerated concentration for 28 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia
Keywords
Myopia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Model Description
Single-center, Open-label, first-in-human dose-escalation.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.025% SHJ002
Arm Type
Experimental
Arm Description
0.025% SHJ002 Sterile Ophthalmic Solution
Arm Title
0.080% SHJ002
Arm Type
Experimental
Arm Description
0.080% SHJ002 Sterile Ophthalmic Solution
Arm Title
0.25% SHJ002
Arm Type
Experimental
Arm Description
0.25% SHJ002 Sterile Ophthalmic Solution
Arm Title
SHJ002 - Maximum tolerated concentration
Arm Type
Experimental
Arm Description
Maximum tolerated concentration of SHJ002
Intervention Type
Drug
Intervention Name(s)
SHJ - Low concentration
Intervention Description
Topical ophthalmic
Intervention Type
Drug
Intervention Name(s)
SHJ - Mid concentration
Intervention Description
Topical ophthalmic
Intervention Type
Drug
Intervention Name(s)
SHJ - High concentration
Intervention Description
Topical ophthalmic
Intervention Type
Drug
Intervention Name(s)
SHJ - Maximum tolerated
Intervention Description
SHJ - Maximum tolerated
Primary Outcome Measure Information:
Title
Change from baseline in best corrected visual acuity
Description
Change from baseline in best corrected visual acuity
Time Frame
3 days (Part 1) and 28 days (Part 2)
Title
Incidence of Adverse Events
Description
Incidence of Adverse Events
Time Frame
3 days (Part 1) and 28 days (Part 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Non-cycloplegic sphere from +1.50 to -4.75 Diopters in one or both eyes.
A minor able to complete all study assessments and comply with the protocol and has a parent or caregiver willing and able to follow study instructions, comply with the protocol and attend study visits with the subject as required, in the opinion of the Investigator.
Literate and able to orally communicate.
Exclusion Criteria:
Non-cycloplegic sphere worse than -4.75 Diopters
Axial length > 26 mm
Hyperopia worse than +1.50 Diopters
Anisometropia (difference of myopic power >2.00 D).
Astigmatism > 1.5 D.
Intraocular pressure > 21 mm Hg or < 6 mm Hg.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suh-Hang H. Juo, MD, Ph.D.
Organizational Affiliation
Sunhawk Vision Biotech, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Kaohsiung Veterans General Hospital
City
Kaohsiung City
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects
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