CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 670 enrolled
Drug / intervention
NVK-002 Concentration 1 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03350620
NCT03350620Phase 3Completed
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A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia

Vyluma, Inc.·interventional·Posted Nov 22, 2017·Updated Nov 27, 2024

In Brief

A Phase 3 clinical trial evaluating NVK-002 Concentration 1, NVK-002 Concentration 2, and 1 other intervention for Myopia. Completed, enrolled 670 participants across 26 sites in 6 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyopia
CountriesHungary, Ireland, Netherlands, Spain, United Kingdom, United States
CollaboratorsSyneos Health

Timeline

Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedNov 22, 2017
Enrollment StartNov 20, 2017
Primary CompletionSep 7, 2022
Study CompletionOct 19, 2023
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.6 years ago

Interventions

NVK-002 Concentration 1drug

Study medication will be administered, once daily (QD)

NVK-002 Concentration 2drug

Study medication will be administered, once daily (QD)

Placebodrug

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