Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

• Status: Active, not recruiting
• Trial end date: 2022-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sunhawk Vision Biotech, Inc.

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.