NCT03918915

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

A Multicenter, Randomized, Double-masked, Vehicle-controlled Study to Assess the Safety and Efficacy of SYD-101 Ophthalmic Solution for the Treatment of Myopia in Children

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 852 (actual)
• Sponsor: Sydnexis, Inc. · Industry
• Sex: All
• Age: 3 Years – 14 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This will be a 3-arm, multicentered, randomized, double-masked, vehicle-controlled study conducted in 2 parts. Part 1 is the primary treatment period of 3 years, during which participants will receive 1 of 3 masked medications. Part 2 is the randomized withdrawal period of 1 year, during which participants originally receiving Vehicle will receive SYD-101, and participants originally receiving SYD-101 will receive either Vehicle or SYD-101.

Conditions

• Nearsightedness
• Near Sightedness
• Near-sightedness

Interventions

Type	Name	Description
DRUG	SYD-101 0.01%	Sterile topical ophthalmic solution
DRUG	SYD-101 0.03%	Sterile topical ophthalmic solution
DRUG	Vehicle	Sterile topical ophthalmic solution without active ingredient

Timeline

• Start date: 2019-04-24
• Primary completion: 2024-05-02
• Completion: 2025-05-01
• First posted: 2019-04-18
• Last updated: 2026-01-15

Locations

47 sites across 3 countries: United States, Austria, Slovakia

Regulatory

• FDA-regulated drug study