Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

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

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.

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.