CHAMP: Study of NVK-002 in Children With Myopia

• Status: Active, not recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nevakar, Inc.; Nevakar, LLC
• Collaborators: INC Research; Syneos Health

Criteria

Inclusion Criteria:

1. Children aged 3 to ≤ 17.0 years.

2. 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:

1. If present, astigmatism more than -1.50 D in either eye.

2. Current or history of amblyopia or strabismus.

3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).

4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).

5. Serious systemic illness that, in the Investigator's opinion, would render the subject ineligible.

6. Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication.