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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: Completed Phase 3 study of Myopia, sponsored by Vyluma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of subjects' eyes that show \< 0.50 D myopia progression (SER, spherical equivalent refraction) at the Month 36 visit.
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
| Field | Value |
|---|---|
| Enrollment Target | 670 participants |
| Start Date | 2017-11-20 |
| Est. Completion | 2023-10-19 |
| Phase | Phase 3 |
What the finished NCT03350620 record still lists
NCT03350620 is an interventional study that assigns participants to a tested intervention. The registered 670 participants enrollment target is mid-sized for trials with a published cap, above the 261-participant average among 90 other Myopia trials with a reported enrollment target (157% higher).
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 names 20 study sites across 16 states, led by 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03350620's enrollment target sits among peer trials
670 7th of 90 higher than 84 of 90 other Myopia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myopia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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