MyopiaPhase 3NCT03350620
CHAMP: Study of NVK-002 in Children With Myopia
A Phase 3 study testing NVK-002 Concentration 1 and NVK-002 Concentration 2 in people with Myopia, run by Vyluma, Inc. at 26 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Myopia
- What is being tested?
- NVK-002 Concentration 1 and NVK-002 Concentration 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 670 participants
- Where
- 26 sitesin 6 countries
- Study dates
- 20 Nov 2017to 19 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 3 to ≤ 17.0 years.
- Myopia SER of at least -0.50 D and no worse than -6.00 D myopia in each eye as measured by cycloplegic autorefraction.
Who cannot join
- If present, astigmatism more than -1.50 D in either eye.
- Current or history of amblyopia or strabismus.
- History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
- History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).
- Serious systemic illness that, in the Investigator's opinion, would render the subject ineligible.
- Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication.
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
United States20 sites
Site #015
Berkeley, California, 94720
Site #006
Boston, Massachusetts, 02115
Site #001
Columbus, Ohio, 43210
Site #005
Danbury, Connecticut, 06810
Site #011
Elkins Park, Pennsylvania, 19027
Site #018
Forest Grove, Oregon, 97116
Site #003
Fullerton, California, 92831
Site #012
Kirkland, Washington, 98034
Site #017
Lancaster, Pennsylvania, 17601
Site #021
Madison, Wisconsin, 53705
Site #004
Maitland, Florida, 32751
Site #008
Memphis, Tennessee, 38104
Site #002
New York, New York, 10036
Site #024
Peoria, Illinois, 61615
Site #013
Raleigh, North Carolina, 27603
Site #007
San Antonio, Texas, 78240
Site #016
San Diego, California, 92129
Site #020
Spokane, Washington, 99204
Site #014
St Louis, Missouri, 63110
Site #009
Tucson, Arizona, 85711
United Kingdom2 sites
Site #103
Coleraine, BT52 1HS
Site #106
London, EC1V 2PD
About this study
Official title: A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 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 Vehicle following 3 years of treatment in children with progressive myopia.
Read the detailed description
This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages.
Stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications.
Stage 2 is a randomized follow-up phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications, with subjects initially randomized to Vehicle only eligible for randomization to low or high-dose NVK-002.
Treatment arms are:
- NVK-002 low dose concentration
- NVK-002 high dose concentration
- Vehicle (placebo)
- Conditions
- Myopia
- Being tested
- NVK-002 Concentration 1, NVK-002 Concentration 2, Placebo
- Keywords
- child, myopia, nearsightedness
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVK-002 Concentration 1Drug
Also called NVK-002 Conc 1
Study medication will be administered, once daily (QD)
NVK-002 Concentration 2Drug
Also called NVK-002 Conc 2
Study medication will be administered, once daily (QD)
PlaceboDrug
Also called Vehicle
Vehicle (placebo) will be administered, once daily (QD)
| Study group | Role | What they receive |
|---|---|---|
| NVK-002 Concentration 1 | Experimental | 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. Receives: Drug: NVK-002 Concentration 1 |
| NVK-002 Concentration 2 | Experimental | 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. Receives: Drug: NVK-002 Concentration 2 |
| Vehicle (Placebo) | Placebo comparator | 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit
Number of subjects' eyes that show < 0.50 D myopia progression (SER, spherical equivalent refraction) at the Month 36 visit.
Measured: 36 Months
Secondary outcomes (1)
Change From Baseline in SER (Spherical Equivalent Refraction)
Change from baseline in SER (spherical equivalent refraction).
Measured: Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start20 Nov 2017
- Primary completion7 Sep 2022
- Study completion19 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages. Stage 1 is to assess the primary and secondary endpoints. Stage 2 is an extension stage for exploratory endpoints. Stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications. Stage 2 is a randomized cross-over phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications with subjects initially randomized to Vehicle only eligible for randomization to low or high dose NVK-002.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 670 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vyluma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Responsible party
- Sponsor
- Investigators
- Houman Hemmati, MD, Study director, Nevakar, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350620
- Sponsor's protocol ID
- CP-NVK002-0001
- Other IDs
- 2018-001077-24, 2018
- Status last verified
- Oct 2024
- First submitted
- 16 Nov 2017
- Last updated
- 27 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zadnik K, Schulman E, Flitcroft I, Fogt JS, Blumenfeld LC, Fong TM, Lang E, Chandler SP, Hemmati HD; CHAMP trial Group Investigators. Negligible Rebound in Myopia Progression Following Cessation of Treatment with 0.01% Atropine for 3 years: Year-4 Results from the CHAMP Phase 3 Clinical Trial. Ophthalmic Physiol Opt. 2026 Jul;46(3):626-634. doi: 10.1007/s44402-026-00064-w. Epub 2026 Apr 8.
PubMed 41949794Zadnik K, Schulman E, Flitcroft I, Fogt JS, Blumenfeld LC, Fong TM, Lang E, Hemmati HD, Chandler SP; CHAMP Trial Group Investigators. Efficacy and Safety of 0.01% and 0.02% Atropine for the Treatment of Pediatric Myopia Progression Over 3 Years: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Oct 1;141(10):990-999. doi: 10.1001/jamaophthalmol.2023.2097.
PubMed 37261839
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia
- ClinicalTrials.gov ID
- NCT03350620
- Acronym / sponsor ID
- CP-NVK002-0001
- Conditions
- Myopia
- Keywords
- child, myopia, nearsightedness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 670 participants (actual)
- Lead sponsor
- Vyluma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 7 Sep 2022 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Posted 27 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages.
Stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications.
Stage 2 is a randomized follow-up phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications, with subjects initially randomized to Vehicle only eligible for randomization to low or high-dose NVK-002.
Treatment arms are:
- NVK-002 low dose concentration
- NVK-002 high dose concentration
- Vehicle (placebo)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- This will be a 3-arm randomized, multicenter, double-masked, placebo-controlled study conducted in 2 stages. Stage 1 is to assess the primary and secondary endpoints. Stage 2 is an extension stage for exploratory endpoints. Stage 1 is a safety and efficacy phase of 3 years in duration, during which subjects will be allocated to 1 of 3 study medications. Stage 2 is a randomized cross-over phase of 1 year in duration, during which subjects will be re-randomized to receive 1 of the 3 study medications with subjects initially randomized to Vehicle only eligible for randomization to low or high dose NVK-002.
| Arm | Type | Receives |
|---|---|---|
| NVK-002 Concentration 1 | Experimental | Drug: NVK-002 Concentration 1Stage 1: Subjects will be randomized to NVK-002 Concentration 1 Stage 2: Subjects will be re-randomized to one of the three treatment arms. |
| NVK-002 Concentration 2 | Experimental | Drug: NVK-002 Concentration 2Stage 1: Subjects will be randomized to NVK-002 Concentration 2 Stage 2: Subjects will be re-randomized to one of the three treatment arms. |
| Vehicle (Placebo) | Placebo comparator | Drug: PlaceboStage 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 |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children aged 3 to ≤ 17.0 years.
- Myopia SER of at least -0.50 D and no worse than -6.00 D myopia in each eye as measured by cycloplegic autorefraction.
Key exclusion criteria (6 listed)
- If present, astigmatism more than -1.50 D in either eye.
- Current or history of amblyopia or strabismus.
- History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
- History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).
- Serious systemic illness that, in the Investigator's opinion, would render the subject ineligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVK-002 Concentration 1Also: NVK-002 Conc 1Study medication will be administered, once daily (QD) | Drug | NVK-002 Concentration 1 |
| NVK-002 Concentration 2Also: NVK-002 Conc 2Study medication will be administered, once daily (QD) | Drug | NVK-002 Concentration 2 |
| PlaceboAlso: VehicleVehicle (placebo) will be administered, once daily (QD) | Drug | Vehicle (Placebo) |
Primary outcome
Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit
Time frame: 36 Months
Number of subjects' eyes that show < 0.50 D myopia progression (SER, spherical equivalent refraction) at the Month 36 visit.
1 secondary outcome
Change From Baseline in SER (Spherical Equivalent Refraction)
Time frame: Month 36
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41949794Zadnik K, Schulman E, Flitcroft I, Fogt JS, Blumenfeld LC, Fong TM, Lang E, Chandler SP, Hemmati HD; CHAMP trial Group Investigators. Negligible Rebound in Myopia Progression Following Cessation of Treatment with 0.01% Atropine for 3 years: Year-4 Results from the CHAMP Phase 3 Clinical Trial. Ophthalmic Physiol Opt. 2026 Jul;46(3):626-634. doi: 10.1007/s44402-026-00064-w. Epub 2026 Apr 8.
- Derived from this study: PubMed 37261839Zadnik K, Schulman E, Flitcroft I, Fogt JS, Blumenfeld LC, Fong TM, Lang E, Hemmati HD, Chandler SP; CHAMP Trial Group Investigators. Efficacy and Safety of 0.01% and 0.02% Atropine for the Treatment of Pediatric Myopia Progression Over 3 Years: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Oct 1;141(10):990-999. doi: 10.1001/jamaophthalmol.2023.2097.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Houman Hemmati, MD study director
Nevakar, Inc.
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NVK-002 Concentration 1 and NVK-002 Concentration 2 in people with Myopia, run by Vyluma, Inc. at 26 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in United States, United Kingdom, Hungary, Ireland, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit (time frame: 36 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03350620, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024; AzTrials last refreshed its copy on 7 Nov 2026.