CHAMP: Study of NVK-002 in Children With Myopia

Vyluma, Inc.670 enrolled

Overview

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.

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

670

Conditions

Myopia

Interventions

NVK-002 Concentration 1DRUG

Study medication will be administered, once daily (QD)

NVK-002 Concentration 2DRUG

Study medication will be administered, once daily (QD)

PlaceboDRUG

Vehicle (placebo) will be administered, once daily (QD)

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Children aged 3 to ≤ 17.0 years. 2. 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: 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.

Locations (26)

Site #009

Tucson, Arizona, United States

Outcomes

Primary Outcomes

Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit

Number of subjects' eyes that show \< 0.50 D myopia progression (SER, spherical equivalent refraction) at the Month 36 visit.

Time frame: 36 Months

Secondary Outcomes

Change From Baseline in SER (Spherical Equivalent Refraction)

Change from baseline in SER (spherical equivalent refraction).

Time frame: Month 36

Data from ClinicalTrials.gov

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