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NCT03350620 · ClinicalTrials.gov registry record · Phase 3

CHAMP: Study of NVK-002 in Children With Myopia

A Phase 3 study of Myopia, sponsored by Vyluma.

Completed
Registry status
Phase 3
Development phase
670
Enrollment target
20
Study locations

NCT03350620 is a Phase 3 study of Myopia that has completed, run by Vyluma. The registered enrollment target is 670 participants, above the 261-participant average among 90 other Myopia trials with a reported enrollment target (157% higher). The trial reports 20 study locations across 16 states.

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The verdict

NCT03350620, a Phase 3 study of Myopia, has completed, sponsored by Vyluma.

COMPLETED
Registry status
Phase 3
Development phase
670 participants
Enrollment target
20
Study locations

Study 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 Studied

Interventions

  • DRUG Placebo
  • DRUG NVK-002 Concentration 1
  • DRUG NVK-002 Concentration 2

Study Locations (20)

California

  • Site #015 - Berkeley
  • Site #003 - Fullerton
  • Site #016 - San Diego

Pennsylvania

  • Site #011 - Elkins Park
  • Site #017 - Lancaster

Washington

  • Site #012 - Kirkland
  • Site #020 - Spokane

Arizona

  • Site #009 - Tucson

Connecticut

  • Site #005 - Danbury

Florida

  • Site #004 - Maitland

Illinois

  • Site #024 - Peoria

Massachusetts

  • Site #006 - Boston

Trial Details

FieldValue
Enrollment Target 670 participants
Start Date 2017-11-20
Est. Completion 2023-10-19
Phase Phase 3

Sponsor

Vyluma

1 total trials

What the Registry Record Tells You About NCT03350620

The ClinicalTrials.gov registry entry for NCT03350620 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 670 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 261-participant average among 90 other Myopia trials with a reported enrollment target (157% higher). The listed sponsor is Vyluma, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Myopia appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.

NCT03350620 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Pennsylvania, Washington.

Frequently Asked Questions

What is clinical trial NCT03350620 about?

NCT03350620 is a clinical study titled "CHAMP: Study of NVK-002 in Children With Myopia". 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 ...

What is the current status of trial NCT03350620?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 670 participants. The study started on 2017-11-20. Estimated completion is 2023-10-19.

What conditions does trial NCT03350620 study?

This clinical trial studies the following conditions: Myopia.

What interventions are being tested in trial NCT03350620?

The interventions under investigation include: Placebo (DRUG), NVK-002 Concentration 1 (DRUG), NVK-002 Concentration 2 (DRUG).

Who is sponsoring clinical trial NCT03350620?

This trial is sponsored by Vyluma, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03350620 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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