CHAMP: Study of NVK-002 in Children With Myopia

Completed · Phase 3 · Has a placebo group

Conditions studied: Myopia

In brief

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.

Key facts

Study ID

NCT03350620

Run by

Vyluma, Inc.

People needed

670

Starts

2017-11-20

Expected to finish

2023-10-19

Last updated by the study team

2024-11-27

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Site #009 — Tucson, Arizona, United States
• Site #015 — Berkeley, California, United States
• Site #003 — Fullerton, California, United States
• Site #016 — San Diego, California, United States
• Site #005 — Danbury, Connecticut, United States
• Site #004 — Maitland, Florida, United States
• Site #024 — Peoria, Illinois, United States
• Site #006 — Boston, Massachusetts, United States
• Site #014 — St Louis, Missouri, United States
• Site #002 — New York, New York, United States
• Site #013 — Raleigh, North Carolina, United States
• Site #001 — Columbus, Ohio, United States
• Site #018 — Forest Grove, Oregon, United States
• Site #011 — Elkins Park, Pennsylvania, United States
• Site #017 — Lancaster, Pennsylvania, United States
• Site #008 — Memphis, Tennessee, United States
• Site #007 — San Antonio, Texas, United States
• Site #012 — Kirkland, Washington, United States
• Site #020 — Spokane, Washington, United States
• Site #021 — Madison, Wisconsin, United States
• Site #104 — Budapest, Hungary
• Site #101 — Dublin, Ireland
• Site # 105 — Rotterdam, Netherlands
• Site #107 — Barcelona, Spain
• Site #103 — Coleraine, United Kingdom

Full record on ClinicalTrials.gov

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