SYD-101 for Myopia

(STAR Trial)

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether an eye solution called SYD-101 can slow the progression of myopia (nearsightedness) in children. Myopia is common and can lead to serious eye problems if it worsens over time, so early treatments are important. The study involves different groups; some children will receive varying doses of SYD-101, while others will receive a placebo (a harmless, inactive solution). Children with myopia between 0.5 to 6.0 diopters who wear single vision glasses or contact lenses are ideal candidates for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SYD-101, an eye solution designed to slow nearsightedness in children, has not raised safety concerns. The FDA reviewed the treatment and found no safety issues, though they requested additional evidence to confirm its effectiveness. While more data is needed to demonstrate its efficacy, patients have tolerated it well in studies so far. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for myopia?

Unlike traditional myopia treatments, which often involve corrective lenses or refractive surgery, SYD-101 is a topical eye drop administered at bedtime. Researchers are excited about SYD-101 because it offers a non-invasive and potentially more convenient alternative for managing myopia. Additionally, SYD-101 may work by slowing down the progression of myopia rather than just correcting vision, which could be a game-changer for long-term eye health. This approach targets the root problem of myopia progression instead of just the symptoms, setting it apart from existing options.

What evidence suggests that SYD-101 could be an effective treatment for myopia?

Research has shown that SYD-101 may slow the worsening of nearsightedness in children. In studies, it reduced the progression of nearsightedness by -0.75 diopters. However, the FDA did not approve it, citing insufficient evidence. This decision raises concerns about its effectiveness in treating nearsightedness in children. While the treatment appears promising, further research is necessary to confirm its benefits. Participants in this trial will receive varying doses of SYD-101 or a vehicle, enabling researchers to further evaluate its effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: SYD-101 0.03% Experimental Treatment 1 Intervention

1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.03% Part 2: participants will be re-randomized to SYD-101 0.03% or Vehicle

Group II: SYD-101 0.01% Experimental Treatment 1 Intervention

1 drop in each eye at bedtime. Part 1: participants will be randomized to SYD-101 0.01% Part 2: participants will be re-randomized to SYD-101 0.01% or Vehicle

Group III: Vehicle Placebo Group 1 Intervention

1 drop in each eye at bedtime. Part 1: participants will be randomized to Vehicle Part 2: participants will be re-randomized to SYD-101 0.03%

Who Is Running the Clinical Trial?

Sydnexis, Inc.

Lead Sponsor

Trials

1

Recruited

850+

Citations

1.

healio.com

healio.com/news/optometry/20251024/fda-declines-to-approve-syd101-for-slowing-pediatric-myopia

FDA does not approve SYD-101 for slowing pediatric myopia

SYD-101 met its primary phase 3 efficacy endpoint, but the FDA said the data did not support its effectiveness in pediatric myopia.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03918915?cond=%22Myopia%22&viewType=Table&rank=1

The Safety and Efficacy of SYD-101 in Children With Myopia

Severe myopia is associated with an increased risk of developing other eye conditions such as glucoma, cataracts and retinal detachment, which may lead to ...

3.

ophthalmologytimes.com

ophthalmologytimes.com/view/fda-issues-complete-response-letter-to-sydnexis-for-syd-101-in-pediatric-myopia

FDA issues Complete Response Letter to Sydnexis for ...

It achieved its primary efficacy goal, which measured the proportion of participants showing confirmed myopia progression of -0.75 D, a ...

4.

ophthalmologyadvisor.com

ophthalmologyadvisor.com/news/fda-denies-syndexis-approval-for-pediatric-myopia-treatment/

FDA Denies Sydnexis Approval for Pediatric Myopia ...

Study participants with myopia of 0.5 D (diopters) to 6.00 D in both eyes were randomly assigned to receive 1 drop of SYD-101 or placebo in each ...

5.

pharmacytimes.com

pharmacytimes.com/view/fda-cites-insufficient-data-for-syd-101-potential-therapy-to-slow-pediatric-myopia-progression

FDA Cites Insufficient Data for SYD-101, Potential Therapy ...

The FDA's complete response letter highlighted insufficient evidence for SYD-101's efficacy in slowing pediatric myopia progression, despite ...

6.

contemporarypediatrics.com

contemporarypediatrics.com/view/fda-issues-crl-for-syd-101-to-treat-progression-of-pediatric-myopia

FDA issues CRL for SYD-101 to treat progression of ...

FDA issued a complete response letter for Sydnexis' SYD-101, citing insufficient efficacy data but no safety concerns.

7.

reviewofmm.com

reviewofmm.com/fda-delays-approval-of-syd-101/

FDA Delays Approval of Sydnexis' SYD-101 ...

The FDA has issued Sydnexis a Complete Response Letter for SYD-101, asking the company for more evidence before approval.