Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Myopia Clinical Trial

Official title:

An Intra-subject Dose Escalation Phase 1 Study to Determine the Safety and Tolerability of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04928144
• Other study ID #: SHJ002-CS201
• Status: Completed
• Phase: Phase 1
• Start date: July 2, 2021
• Est. completion date: September 17, 2021

Study information

• Verified date: March 2022
• Source: Sunhawk Vision Biotech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 17, 2021
• Est. primary completion date: September 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Drug:
• SHJ - Low concentration
Topical ophthalmic
• SHJ - Mid concentration
Topical ophthalmic
• SHJ - High concentration
Topical ophthalmic
• SHJ - Maximum tolerated
SHJ - Maximum tolerated

Locations

Country	Name	City	State
Taiwan	Kaohsiung Veterans General Hospital	Kaohsiung City

Sponsors (1)

Lead Sponsor	Collaborator
Sunhawk Vision Biotech, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in best corrected visual acuity	Change from baseline in best corrected visual acuity	3 days (Part 1) and 28 days (Part 2)
Primary	Incidence of Adverse Events	Incidence of Adverse Events	3 days (Part 1) and 28 days (Part 2)