Trial · NCT03350620
CHAMP: Study of NVK-002 in Children With Myopia
NCT03350620, Phase 3, Completed, Vyluma, Inc.; results first posted 2024-11-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CHAMP: Study of NVK-002 in Children With Myopia. Trials, record NCT03350620. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03350620
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CHAMP: Study of NVK-002 in Children With Myopia
- NCT number
- NCT03350620
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 670 participants, actual
- Lead sponsor
- Vyluma, Inc.
- Conditions
- Myopia
- Interventions
- NVK-002 Concentration 1, NVK-002 Concentration 2, Placebo
- First posted
- 2017-11-22
- Last updated
- 2024-11-27
- Other registries' IDs
- eudract:2018-001077-24
- Results first posted
- 2024-11-27
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit | 36 Months | Number of subjects' eyes that show \< 0.50 D myopia progression (SER, spherical equivalent refraction) at the Month 36 visit. |
| Secondary | Change From Baseline in SER (Spherical Equivalent Refraction) | Month 36 | Change from baseline in SER (spherical equivalent refraction). |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit | 36 Months | ITT | participants' eyes | NUMBER |
| SECONDARY | Change From Baseline in SER (Spherical Equivalent Refraction) | Month 36 | ITT | Diopter | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit | NVK-002 Concentration 1 | 79 | participants' eyes | ||
| Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit | NVK-002 Concentration 2 | 106 | participants' eyes | ||
| Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit | Vehicle (Placebo) | 61 | participants' eyes | ||
| Change From Baseline in SER (Spherical Equivalent Refraction) | NVK-002 Concentration 1 | -0.85 | Inter-Quartile Range -3.28 to 1.22 | Diopter | |
| Change From Baseline in SER (Spherical Equivalent Refraction) | NVK-002 Concentration 2 | -1.02 | Inter-Quartile Range -3.94 to 0.89 | Diopter | |
| Change From Baseline in SER (Spherical Equivalent Refraction) | Vehicle (Placebo) | -1.10 | Inter-Quartile Range -4.44 to 3.60 | Diopter |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Stage 1 | STARTED | NVK-002 Concentration 1 | 164 | |
| Stage 1 | STARTED | NVK-002 Concentration 2 | 247 | |
| Stage 1 | STARTED | Vehicle (Placebo) | 165 | |
| Stage 1 | COMPLETED | NVK-002 Concentration 1 | 127 | |
| Stage 1 | COMPLETED | NVK-002 Concentration 2 | 207 | |
| Stage 1 | COMPLETED | Vehicle (Placebo) | 143 | |
| Stage 1 | NOT COMPLETED | NVK-002 Concentration 1 | 37 | |
| Stage 1 | NOT COMPLETED | NVK-002 Concentration 2 | 40 | |
| Stage 1 | NOT COMPLETED | Vehicle (Placebo) | 22 | |
| Stage 2 | STARTED | NVK-002 Concentration 1 | 159 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events168
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | nasopharyngitis | Infections and infestations | Stage 1: NVK-002 Concentration 1 | 17 | 164 | |
| other | nasopharyngitis | Infections and infestations | Stage 1: NVK-002 Concentration 2 | 30 | 247 | |
| other | nasopharyngitis | Infections and infestations | Stage 1: Vehicle (Placebo) | 22 | 162 | |
| other | nasopharyngitis | Infections and infestations | Stage 2: NVK-002 Concentration 1 | 14 | 159 | |
| other | nasopharyngitis | Infections and infestations | Stage 2: NVK-002 Concentration 2 | 5 | 162 | |
| other | nasopharyngitis | Infections and infestations | Stage 2: Vehicle (Placebo) | 6 | 99 | |
| other | COVID-19 | Infections and infestations | Stage 1: NVK-002 Concentration 1 | 9 | 164 | |
| other | COVID-19 | Infections and infestations | Stage 1: NVK-002 Concentration 2 | 27 | 247 | |
| other | COVID-19 | Infections and infestations | Stage 1: Vehicle (Placebo) | 18 | 162 | |
| other | COVID-19 | Infections and infestations | Stage 2: NVK-002 Concentration 1 | 14 | 159 |
1 to 10 of 168Source ClinicalTrials.gov
See all 168 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Stage 1: NVK-002 Concentration 1 | 0 | 164 |
| Total, all-cause mortality | Stage 1: NVK-002 Concentration 2 | 0 | 247 |
| Total, all-cause mortality | Stage 1: Vehicle (Placebo) | 0 | 162 |
| Total, all-cause mortality | Stage 2: NVK-002 Concentration 1 | 0 | 159 |
| Total, all-cause mortality | Stage 2: NVK-002 Concentration 2 | 0 | 162 |
| Total, all-cause mortality | Stage 2: Vehicle (Placebo) | 0 | 99 |
| Total, other adverse events | Stage 1: NVK-002 Concentration 1 | 56 | 164 |
| Total, other adverse events | Stage 1: NVK-002 Concentration 2 | 92 | 247 |
| Total, other adverse events | Stage 1: Vehicle (Placebo) | 75 | 162 |
| Total, other adverse events | Stage 2: NVK-002 Concentration 1 | 43 | 159 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03350620
GET https://conductscience.org/api/trials/v1/NCT03350620/events?page=2