CHAMP: Study of NVK-002 in Children With Myopia

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 follow-up 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)

Inclusion criteria

• Children aged 3 to ≤ 17.0 years.
• Myopia SER of at least -0.50 D and no worse 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).
• Serious systemic illness that, in the Investigator's opinion, would render the subject ineligible.
• Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication.