Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Sunhawk Vision Biotech, Inc.12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myopia

Interventions

SHJ - Low concentrationDRUG

Topical ophthalmic

SHJ - Mid concentrationDRUG

Topical ophthalmic

SHJ - High concentrationDRUG

Topical ophthalmic

Eligibility

Sex: ALLMin age: 10 YearsMax age: 15 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

Change from baseline in best corrected visual acuity

Time frame: 3 days (Part 1) and 28 days (Part 2)

Incidence of Adverse Events

Time frame: 3 days (Part 1) and 28 days (Part 2)

Data from ClinicalTrials.gov

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