Phase 1 Study of SHJ002 Sterile Ophthalmic Solution in Pediatric Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-02

Study Completion Date

2021-09-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Study of SHJ002 Sterile Ophthalmic Solution for Myopia Control

NCT06579287

Myopia, Progressive

ACTIVE_NOT_RECRUITING PHASE2

Phase II Study of SHJ002 Sterile Ophthalmic Solution Compared With Vehicle in Participants With Dry Eye Disease

NCT05486728

Dry Eye Disease

COMPLETED PHASE2

Exploratory Study to Investigate the Bioactivity, Ocular and Systemic Safety, Tolerability, and Pharmacokinetics Following Single and Multiple Intravitreal Administrations of KSI-301 in Subjects With wAMD, DME and RVO

NCT03790852

TERMINATED PHASE1

A Study of STSP-0902 Ophthalmic Solution in Healthy Subjects

NCT06597422

Neurotrophic Keratitis

ACTIVE_NOT_RECRUITING PHASE1

Ocular Safety and Usability Study for FYB203 PFS

NCT06708637

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Single-center, Open-label, first-in-human dose-escalation.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.025% SHJ002

0.025% SHJ002 Sterile Ophthalmic Solution

Group Type EXPERIMENTAL

SHJ - Low concentration

Intervention Type DRUG

Topical ophthalmic

0.080% SHJ002

0.080% SHJ002 Sterile Ophthalmic Solution

Group Type EXPERIMENTAL

SHJ - Mid concentration

Intervention Type DRUG

Topical ophthalmic

0.25% SHJ002

0.25% SHJ002 Sterile Ophthalmic Solution

Group Type EXPERIMENTAL

SHJ - High concentration

Intervention Type DRUG

Topical ophthalmic

SHJ002 - Maximum tolerated concentration

Maximum tolerated concentration of SHJ002

Group Type EXPERIMENTAL

SHJ - Maximum tolerated

Intervention Type DRUG

SHJ - Maximum tolerated

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHJ - Low concentration

Topical ophthalmic

Intervention Type DRUG

SHJ - Mid concentration

Topical ophthalmic

Intervention Type DRUG

SHJ - High concentration

Topical ophthalmic

Intervention Type DRUG

SHJ - Maximum tolerated

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes