Trial | NCT03350620  Report issue

Title

CHAMP: Study of NVK-002 in Children With Myopia
A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Active, not recruiting

  • Study Participants

    576
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 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.

Treatment arms are:

NVK-002 low dose concentration
NVK-002 high dose concentration
Vehicle (placebo)
Study Started
Nov 20
2017
Primary Completion
Aug 07
2022
Anticipated
Study Completion
Aug 07
2023
Anticipated
Last Update
Mar 10
2022

Drug NVK-002 Concentration 1

Study medication will be administered, once daily (QD)

  • Other names: NVK-002 Conc 1

Drug NVK-002 Concentration 2

Study medication will be administered, once daily (QD)

  • Other names: NVK-002 Conc 2

Drug Placebo

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

  • Other names: Vehicle

NVK-002 Concentration 1 Experimental

Stage 1: Subjects will be randomized to NVK-002 Concentration 1 Stage 2: Subjects will be re-randomized to one of the three treatment arms.

NVK-002 Concentration 2 Experimental

Stage 1: Subjects will be randomized to NVK-002 Concentration 2 Stage 2: Subjects will be re-randomized to one of the three treatment arms.

Vehicle (Placebo) Placebo Comparator

Stage 1: Subjects will be randomized to Vehicle (Placebo) Stage 2: Subjects will be re-randomized to one of the two experimental NVK-002 treatment arms

Criteria 

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).
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.
No Results Posted