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SYD-101 for Myopia (STAR Trial)

Q: What is the government's opinion on Vehicle?

This is a Phase 3 trial, which means that while there is some data supporting efficacy, multiple rounds of data collected support the safety of the Vehicle.

Q: Are participants being enrolled in this trial at the current time?

This study is no longer recruiting patients. The listing was first posted on April 24th, 2019 and the most recent update occurred on January 20th, 2022. If you are looking for other studies, there are 101 trials currently searching for patients with nearsightedness and 22 studies for Vehicle admitting participants.

Q: Is this trial widely available in urban areas?

In total, 41 clinical trial sites are running this experiment, for example Site 109 in Jupiter, or Site 128 in Cranberry Township. A full list of the other 41 locations can be found below.

Q: Do you have any information about other research projects using this same treatment?

At the moment, there are 22 on-going Vehicle clinical trials. Out of those, 6 have progressed to Phase 3 testing. The majority of these trials are being conducted in Shanghai, but there are 149 total research sites for this treatment across the world.

Q: How many people are eligible for this research project?

This trial is no longer recruiting patients. The listing was first posted on April 24th, 2019 but the most recent update occurred on January 20th, 2022. If you are interested in finding other studies, there are 101 trials for nearsightedness and 22 trials for Vehicle that are still open to enrolling patients.

Q: What are the primary reasons people take Vehicle?

Although typically used to treat laughing, vehicle can also help patients with rhinorrhoea, bile fluid and other pupil-related issues.

Q: Are octogenarians included in this experimental research?

As this clinical trial's eligibility requirements state, 3 is the minimum age for participation while 14 years old is the maximum age.

Q: Could you explain the requirements for participating in this experiment?

This study is looking for 852 children, aged 3-14, who suffer from nearsightedness. Additionally, the following must be true of potential patients: Anisometropia ≤1.00 D in both eyes., BCVA (best-corrected visual acuity) Snellen equivalent of 20/32 or better., Myopia of 0.5 D (diopters) to 6.00 D (inclusive) in both eyes., Astigmatism ≤1.50 D in both eyes., If myopia is ≥0.75 D, participant must be wearing single vision eyeglasses or soft, daily-

Phase 3

Waitlist Available

Research Sponsored by Sydnexis, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

If myopia is ≥0.75 D, participant must be wearing single vision eyeglasses or soft, daily-wear, single-vision contact lenses that meet study investigator's criteria.

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months (from date of randomization until date myopia progresses >0.75 d)

Awards & highlights

STAR Trial Summary

This trial investigates the use of SYD-101, an eye solution, in slowing-down the progression of myopia in children.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While not explicitly listed here, potential side effects may include discomfort at the site of application, allergic reactions, temporary visual disturbances such as blurriness and possible long-term impact on eye health.

STAR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I wear glasses or soft contact lenses for my nearsightedness.

STAR Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months (from date of randomization until date myopia progresses >0.75 d)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months (from date of randomization until date myopia progresses >0.75 d)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months (from date of randomization until date myopia progresses >0.75 d) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Myopic progression >0.75 D (diopters)

Secondary outcome measures

Mean annual myopic progression

Mean change from baseline in axial length

Proportion of participants with annual myopia progression rate <=0.25 D/year

+3 more

STAR Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Part 1: SYD-101 Dose 2; Part 2: VehicleExperimental Treatment2 Interventions