SYD-101 for Myopia
(STAR Trial)
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.12345
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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Primary Treatment
Participants receive 1 of 3 masked medications for myopia treatment
Randomized Withdrawal
Participants originally receiving Vehicle will receive SYD-101, and participants originally receiving SYD-101 will receive either Vehicle or SYD-101
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- SYD-101
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sydnexis, Inc.
Lead Sponsor