What side effects are associated with this type of intervention?

Common treatments for myopia, such as atropine eye drops, which are similar to the SYD-101 eye solution being studied, can have side effects including light sensitivity, blurred near vision, and potential allergic reactions. Other topical treatments may also cause ocular irritation or discomfort.

What prior FDA approvals exist?

There is no specific mention of prior FDA approvals for treatments similar to SYD-101 in the provided context. SYD-101 is an eye solution being studied to slow the progression of myopia in children. Generally, treatments for myopia focus on corrective lenses, orthokeratology, and atropine eye drops, which have shown efficacy in slowing myopia progression. However, detailed information on FDA approvals for these treatments is not provided in the context.

What other types of research exist?

Promising alternatives to SYD-101 for myopia treatment include low-dose atropine eye drops, which have been shown to effectively slow myopia progression in children. Orthokeratology (Ortho-K) lenses, which are worn overnight to reshape the cornea, and multifocal contact lenses designed to reduce eye strain and slow myopia progression, are also viable options. Additionally, increased outdoor activity has been recommended as a non-pharmacological approach to reduce the risk of myopia progression.

← Back to Search

Other

SYD-101 for Myopia (STAR Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for myopia, particularly those similar to SYD-101, involve the use of eye solutions that aim to slow the progression of the condition. These treatments typically work by altering the biochemical environment of the eye to reduce the elongation of the eyeball, which is the primary cause of myopia. For instance, some eye solutions may increase the rigidity of the sclera (the white part of the eye) or modulate the signaling pathways that control eye growth. Understanding these mechanisms is crucial for myopia patients because it helps in selecting the most effective treatment options, potentially reducing the risk of severe complications such as glaucoma, cataracts, and retinal detachment associated with advanced myopia.

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

Must not have

Past, present or future plans to use orthokeratology (orthoK), rigid gas-permeable, bifocal, progressive-addition, multi-focal, or other lenses to reduce myopia progression; or the use of atropine, pirenzepine or other anti-muscarinic agent for myopia.

Evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis.

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

Pivotal Trial

Summary

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.

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I do not have any eye infections or inflammation.

Select...

I have had or will have eye surgery.

Select...

I am currently taking a monoamine oxidase inhibitor.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Myopic progression >0.75 D (diopters)

Secondary study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

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