CompletedPhase 1

Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Taiwan12 participantsStarted 2021-07-02

Plain-language 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.

Who can participate

Age range10 Years – 15 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change from baseline in best corrected visual acuity

Timeframe: 3 days (Part 1) and 28 days (Part 2)

Incidence of Adverse Events

Timeframe: 3 days (Part 1) and 28 days (Part 2)

Trial details

NCT IDNCT04928144

SponsorSunhawk Vision Biotech, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-09-17

View on ClinicalTrials.gov More Myopia trials