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: