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

Nearsightedness Clinical Trial

Official title: 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 Active, not recruiting

Clinical Trial 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.

Clinical Trial Description

This will be a 5-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. ;

Related Conditions & MeSH terms

• Myopia
• Near Sightedness
• Near-sightedness
• Nearsightedness

• NCT number: NCT03918915
• Study type: Interventional
• Source: Sydnexis, Inc.
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 24, 2019
• Completion date: June 2025