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NVK-002 Concentration 1 for Near-sightedness

Phase 3
Waitlist Available
Research Sponsored by Nevakar, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 12, month 24, month 36
Awards & highlights

Study Summary

This trial is designed to study whether NVK-002 can safely and effectively slow the progression of myopia in children over a 3 year treatment period, with follow-up observation for one additional year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 12, month 24, month 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 12, month 24, month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit.
Secondary outcome measures
Between-group difference in mean progression rates.
Between-group difference in proportion of subjects who show <-0.75 D progression and the between-group median time to a change in myopia of <-0.75 D.

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: NVK-002 Concentration 2Experimental Treatment1 Intervention
Stage 1: Subjects will be randomized to NVK-002 Concentration 2 Stage 2: Subjects will be re-randomized to one of the three treatment arms.
Group II: NVK-002 Concentration 1Experimental Treatment1 Intervention
Stage 1: Subjects will be randomized to NVK-002 Concentration 1 Stage 2: Subjects will be re-randomized to one of the three treatment arms.
Group III: Vehicle (Placebo)Placebo Group1 Intervention
Stage 1: Subjects will be randomized to Vehicle (Placebo) Stage 2: Subjects will be re-randomized to one of the two experimental NVK-002 treatment arms

Find a Location

Who is running the clinical trial?

Syneos HealthOTHER
172 Previous Clinical Trials
67,878 Total Patients Enrolled
Nevakar, Inc.Lead Sponsor
5 Previous Clinical Trials
435 Total Patients Enrolled
Vyluma, Inc.Lead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I fit the bill to be a contender in this experiment?

"This clinical trial is testing a new treatment for myopia in children and adolescents. To be eligible, patients must be between 3 and 17 years old. A total of 576 patients will be enrolled in the trial."

Answered by AI

Does the FDA sanction NVK-002 Concentration 2?

"NVK-002 Concentration 2 is considered safe, as it is a Phase 3 trial. This means that, while there is still some data to support efficacy, there is multiple rounds of data to support safety."

Answered by AI

Does this research study allow for people who are over the age of 70 to participate?

"According to the age range outlined in the inclusion criteria, the minimum age for enrollment is 3 years old while the maximum age is 17 years old."

Answered by AI

Are there any available vacancies for candidates in this research?

"This particular clinical trial, which was created on November 20th, 2017, is not looking for new patients as of February 22nd, 2022. However, there are 100 other trials that are currently enrolling patients."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
CHAMP: Study of NVK-002 in Children With Myopia
2017. "CHAMP: Study of NVK-002 in Children With Myopia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03350620.
All > Myopia
~78 spots leftby Apr 2025
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