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Completed

NCT Number: NCT04928144

Phase 1 Study 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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SHJ - Low concentration

Drug

Topical ophthalmic

SHJ - Mid concentration

Drug

Topical ophthalmic

SHJ - High concentration

Drug

Topical ophthalmic

SHJ - Maximum tolerated

Drug

SHJ - Maximum tolerated

Primary outcomes

  1. Change from baseline in best corrected visual acuity

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

    Change from baseline in best corrected visual acuity

  2. Incidence of Adverse Events

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

    Incidence of Adverse Events

Sponsors and collaborators

Lead sponsor

Sunhawk Vision Biotech, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 16, 2021
Registry last updated
Mar 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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