CHAMP: Study of NVK-002 in Children With Myopia

Myopia Clinical Trial

Official title: A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia

Status Active, not recruiting

Clinical Trial Summary

Stage 1: To evaluate the safety and efficacy of 2 concentrations of NVK-002 compared to Vehicle (placebo) for slowing the progression of myopia in children over a 3 year treatment period. Stage 2: To observe safety and efficacy in subjects re-randomized to one (1) year of treatment with NVK-002 or Vehicle following 3 years of treatment in children with progressive myopia.

Clinical Trial Description

This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages. Stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications. Stage 2 is a randomized cross-over phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications, with subjects initially randomized to Vehicle only eligible for randomization to low or high-dose NVK-002. Treatment arms are: - NVK-002 low dose concentration - NVK-002 high dose concentration - Vehicle (placebo) ;

Related Conditions & MeSH terms

• Myopia

• NCT number: NCT03350620
• Study type: Interventional
• Source: Nevakar, Inc.
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: November 20, 2017
• Completion date: August 7, 2023