A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia (CHAMP)

Active Clinical Trials // Jun 12 2019

Sponsor: Nevakar, LLC
Principal Investigator: Melanie Schmitt, MD
Study Coordinator: Angie Adler

Study Objective:

In stage 1, the purpose of this study is 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. In stage 2, the purpose of the study is 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.

Study Design:

This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages.

Treatment arms are:

  • NVK-002 low dose concentration
  • NVK-002 high dose concentration
  • Vehicle (placebo)

Diagnosis and Key Eligibility Criteria:

Children aged 3-10 years with myopia spherical equivalent of at least -0.50 diopters and no greater than -6.00 diopters in each eye as measured by cycloplegic autorefraction.

Duration of Study: 4 years

 

For more information, contact Angie Adler 608-265-7557.