SYD-101 for Myopia

(STAR Trial)

Recruiting at 48 trial locations

Overseen By Recruiting sites have contact information. Please contact the sites directly. If there is no contact information

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Sydnexis, Inc.

Must not be taking: Monoamine oxidase inhibitors, Anti-muscarinics

Disqualifiers: Degenerative myopia, Diabetes, Ocular inflammation, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

852 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing SYD-101 eye drops to see if they can slow down nearsightedness in children. The goal is to prevent their eyesight from getting worse too quickly and reduce future eye problems.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using a monoamine oxidase inhibitor or certain treatments for myopia like orthoK lenses or atropine.

Eligibility Criteria

This trial is for children with mild to moderate myopia (0.5-6.00 diopters) and astigmatism up to 1.50 diopters in both eyes, who currently wear glasses or certain contact lenses. They must have good corrected vision (20/32 or better). Kids can't join if they've had eye surgery, plan to use specific lenses or drugs for myopia control, are on MAO inhibitors, have eye inflammation/infection, or conditions like Marfan syndrome.

Inclusion Criteria

Anisometropia ≤1.00 D in both eyes.

Myopia of 0.5 D (diopters) to 6.00 D (inclusive) in both eyes.

BCVA (best-corrected visual acuity) Snellen equivalent of 20/32 or better.

Exclusion Criteria

I have used or plan to use special lenses or medications to slow down my nearsightedness.

I have a condition like Marfan syndrome that could affect my eyesight.

There may be additional requirements for participation in the study that are not listed here.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Primary Treatment

Participants receive 1 of 3 masked medications for myopia treatment

3 years

Randomized Withdrawal

Participants originally receiving Vehicle will receive SYD-101, and participants originally receiving SYD-101 will receive either Vehicle or SYD-101

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• SYD-101

Trial Overview The study tests SYD-101 eye solution at two different doses against a placebo (vehicle) to see if it slows down the worsening of nearsightedness in children. It aims to reduce the risk of severe myopia-related complications by early treatment.

Participant Groups

Group I: Part 1: SYD-101 Dose 2; Part 2: Vehicle Experimental Treatment 2 Interventions

1 drop in each eye at bedtime.

Group II: Part 1: SYD-101 Dose 2; Part 2: SYD-101 Dose 2 Experimental Treatment 1 Intervention

1 drop in each eye at bedtime.

Group III: Part 1: SYD-101 Dose 1; Part 2: Vehicle Experimental Treatment 2 Interventions

1 drop in each eye at bedtime.

Group IV: Part 1: SYD-101 Dose 1; Part 2: SYD-101 Dose 1 Experimental Treatment 1 Intervention

1 drop in each eye at bedtime.

Group V: Part 1: Vehicle; Part 2: SYD-101 Dose 2 Placebo Group 2 Interventions

1 drop in each eye at bedtime.

Who Is Running the Clinical Trial?

Sydnexis, Inc.

Lead Sponsor

Trials

1

Recruited

850+