Clinical trial NCT03350620: CHAMP: Study of NVK-002 in Children With Myopia
Official title: A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myopia
Keywords: child, myopia, nearsightedness
Lead sponsor: Nevakar, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2017-11-22
Enrollment: 670
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages. Stage 1 is to assess the primary and secondary endpoints. Stage 2 is an extension stage for exploratory endpoints.

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.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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)

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit
timeFrame: 36 Months
Secondary outcomes:
measure: Change From Baseline in SER (Spherical Equivalent Refraction)
timeFrame: Month 36
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Site #009
state: Arizona
city: Berkeley
country: United States
facility: Site #015
state: California
city: Fullerton
country: United States
facility: Site #003
state: California
city: San Diego
country: United States
facility: Site #016
state: California
city: Danbury
country: United States
facility: Site #005
state: Connecticut
city: Maitland
country: United States
facility: Site #004
state: Florida
city: Peoria
country: United States
facility: Site #024
state: Illinois
city: Boston
country: United States
facility: Site #006
state: Massachusetts
city: Saint Louis
country: United States
facility: Site #014
state: Missouri
city: New York
country: United States
facility: Site #002
state: New York
city: Raleigh
country: United States
facility: Site #013
state: North Carolina
city: Columbus
country: United States
facility: Site #001
state: Ohio
city: Forest Grove
country: United States
facility: Site #018
state: Oregon
city: Elkins Park
country: United States
facility: Site #011
state: Pennsylvania
city: Lancaster
country: United States
facility: Site #017
state: Pennsylvania
city: Memphis
country: United States
facility: Site #008
state: Tennessee
city: San Antonio
country: United States
facility: Site #007
state: Texas
city: Kirkland
country: United States
facility: Site #012
state: Washington
city: Spokane
country: United States
facility: Site #020
state: Washington
city: Madison
country: United States
facility: Site #021
state: Wisconsin
city: Budapest
country: Hungary
facility: Site #104
city: Dublin
country: Ireland
facility: Site #101
city: Rotterdam
country: Netherlands
facility: Site # 105
city: Barcelona
country: Spain
facility: Site #107
city: Coleraine
country: United Kingdom
facility: Site #103
city: London
country: United Kingdom
facility: Site #106
Study officials:
affiliation: Nevakar, Inc.
name: Houman Hemmati, MD
role: STUDY_DIRECTOR
References: