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

Completed · Phase 3 · Has a placebo group

Conditions studied: Nearsightedness, Near Sightedness, Near-sightedness

In brief

Myopia, or nearsightedness, is the most common eye disorder, often affecting more than 40% of adults in Europe, Asia and the USA. Severe myopia is associated with an increased risk of developing other eye conditions such as glucoma, cataracts and retinal detachment, which may lead to blindness. Early treatment of myopia in children could help slow the condition and minimize the risk of complications later in life. This study investigates the use of SYD-101, an eye solution, in slowing-down the progression of myopia in children.

Key facts

Study ID

NCT03918915

Run by

Sydnexis, Inc.

People needed

852

Starts

2019-04-24

Expected to finish

2025-05-01

Last updated by the study team

2026-07-30

Who can join

Age: 3 and older, up to 14. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site 143 — Irwindale, California, United States
• Site 144 — Pasadena, California, United States
• Site 148 — San Diego, California, United States
• Site 104 — San Diego, California, United States
• Site 110 — Santa Barbara, California, United States
• Site 133 — Sunnyvale, California, United States
• Site 130 — Colorado Springs, Colorado, United States
• Site 100 — Fort Collins, Colorado, United States
• Site 102 — Danbury, Connecticut, United States
• Site 150 — Waterbury, Connecticut, United States
• Site 122 — Fort Lauderdale, Florida, United States
• Site 109 — Jupiter, Florida, United States
• Site 119 — Sweetwater, Florida, United States
• Site 120 — Tamarac, Florida, United States
• Site 124 — Marietta, Georgia, United States
• Site 116 — Chicago, Illinois, United States
• Site 106 — Wilmette, Illinois, United States
• Site 135 — Indianapolis, Indiana, United States
• Site 131 — Munster, Indiana, United States
• Site 137 — Pittsburg, Kansas, United States
• Site 138 — Bangor, Maine, United States
• Site 123 — Boston, Massachusetts, United States
• Site 114 — Washington, Missouri, United States
• Site 132 — Henderson, Nevada, United States
• Site 139 — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

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