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

Launched by SYDNEXIS, INC. · Apr 16, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new eye treatment called SYD-101 to see if it can help slow down the worsening of myopia, also known as nearsightedness, in children. Myopia is a common vision problem where distant objects appear blurry, and it can lead to more serious eye issues later in life if not treated early. The trial is particularly focused on children between the ages of 3 and 14 who have a certain degree of myopia and meet other specific health criteria.

To be eligible for this study, children must have myopia between 0.5 and 6.00 diopters in both eyes, and they should be wearing corrective glasses or contact lenses if their myopia is more than 0.75 diopters. However, children with certain eye conditions or past surgeries, or those currently using specific types of lenses or medications for myopia, cannot participate. If enrolled, participants will receive the SYD-101 treatment and will be monitored by healthcare professionals to assess its safety and effectiveness. This study is an important step in finding better ways to help children with nearsightedness and reduce the risks of future eye problems.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Myopia of 0.5 D (diopters) to 6.00 D (inclusive) in both eyes.
• • Astigmatism ≤1.50 D in both eyes.
• • Anisometropia ≤1.00 D in both eyes.
• • 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.
• • BCVA (best-corrected visual acuity) Snellen equivalent of 20/32 or better.
• Exclusion Criteria:
• • Participants with a history or current evidence of a medical condition predisposing them to degenerative myopia (e.g. Marfan syndrome, Stickler syndrome), or a condition that may affect visual function or development (e.g. diabetes mellitus, chromosome anomaly).
• • Current use of a monoamine oxidase inhibitor.
• • Evidence of any ocular inflammation or infection in either eye, including blepharitis, conjunctivitis, keratitis, and scleritis.
• • 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.
• • History or evidence of ocular surgery or planned future ocular surgery in either eye.
• • Other protocol-defined inclusion/exclusion criteria could apply.