Myopia
Conditions
Keywords
Myopia
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.
Interventions
DRUGSHJ - Low concentration
Topical ophthalmic
DRUGSHJ - Mid concentration
Topical ophthalmic
DRUGSHJ - High concentration
Topical ophthalmic
DRUGSHJ - Maximum tolerated
SHJ - Maximum tolerated
Sponsors
Sunhawk Vision Biotech, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-center, Open-label, first-in-human dose-escalation.
Eligibility
Sex/Gender
ALL
Age
10 Years to 15 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in best corrected visual acuity | 3 days (Part 1) and 28 days (Part 2) | Change from baseline in best corrected visual acuity |
| Incidence of Adverse Events | 3 days (Part 1) and 28 days (Part 2) | Incidence of Adverse Events |
Countries
Taiwan
Outcome results
None listed