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CHAMP: Study of NVK-002 in Children With Myopia

NCT03350620 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 670

Last updated 2024-11-27

Study results available
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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.

Conditions

  • Myopia

Interventions

DRUG

NVK-002 Concentration 1

Study medication will be administered, once daily (QD)

DRUG

NVK-002 Concentration 2

Study medication will be administered, once daily (QD)

DRUG

Placebo

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

Sponsors & Collaborators

Principal Investigators

  • Houman Hemmati, MD · Nevakar, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-20
Primary Completion
2022-09-07
Completion
2023-10-19
FDA Drug
Yes

Countries

  • United States
  • Hungary
  • Ireland
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350620 on ClinicalTrials.gov