CHAMP

Clinical Trials // Melanie Schmitt // Myopia // Ongoing // Pediatrics // Jun 12 2019

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

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

Study objective:

To evaluate the safety and efficacy of 2 concentrations of NVK-002 compared to placebo for slowing the progression of myopia in children.

Study Design:

Study duration is approximately 4 years, and it will be 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

Inclusion criteria:

  • Children aged 3 to ≤ 17.0 years
  • Myopia SER of at least -0.50 D and no greater than -6.00 D myopia in each eye as measured by cycloplegic autorefraction

Exclusion criteria:

  • If present, astigmatism more than -1.50 D in either eye
  • Current or history of amblyopia or strabismus
  • History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity)
  • History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia)
  • Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication

Contact Angie Adler with questions: 608-265-7557. For more information about this study: visit clinicaltrials.gov