CHAMP: Study of NVK-002 in Children With Myopia
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| ClinicalTrials.gov Identifier: NCT03350620 |
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Recruitment Status :
Active, not recruiting
First Posted : November 22, 2017
Last Update Posted : January 5, 2023
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Myopia | Drug: NVK-002 Concentration 1 Drug: NVK-002 Concentration 2 Drug: Placebo | Phase 3 |
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 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.
Treatment arms are:
- NVK-002 low dose concentration
- NVK-002 high dose concentration
- Vehicle (placebo)
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 576 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Intervention Model 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 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 (Participant, Investigator) |
| Masking Description: | If subjects meet eligibility criteria at the Screening/Baseline visit (Day 0), subjects will be randomly assigned to masked study medication. The study will be double masked. The study medication will be provided in identical-appearing laminated pouches with no labeling indicating the identity of the study group or the contents of the ampules. The laminated pouches will contain identical-appearing ampules. Study subjects and study management personnel will be masked to the identity of treatment until after the final database lock. |
| Primary Purpose: | Treatment |
| Official Title: | A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia |
| Actual Study Start Date : | November 20, 2017 |
| Estimated Primary Completion Date : | August 7, 2023 |
| Estimated Study Completion Date : | August 7, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: NVK-002 Concentration 1
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. |
Drug: NVK-002 Concentration 1
Study medication will be administered, once daily (QD)
Other Name: NVK-002 Conc 1 |
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Experimental: NVK-002 Concentration 2
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. |
Drug: NVK-002 Concentration 2
Study medication will be administered, once daily (QD)
Other Name: NVK-002 Conc 2 |
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Placebo Comparator: Vehicle (Placebo)
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 |
Drug: Placebo
Vehicle (placebo) will be administered, once daily (QD)
Other Name: Vehicle |
- The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit. [ Time Frame: 36 Months ]The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit.
- Between-group difference in mean progression rates. [ Time Frame: Month 12, Month 24, Month 36 ]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. [ Time Frame: Month 36 ]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.
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| Ages Eligible for Study: | 3 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Children aged 3 to ≤ 17.0 years.
- Myopia SER of at least -0.50 D and no greater than -6.00 D myopia in each eye as measured by cycloplegic autorefraction.
Exclusion Criteria:
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03350620
Show 26 study locations
| Study Director: | Houman Hemmati, MD | Nevakar, Inc. |
Documents provided by Nevakar, Inc. ( Vyluma, Inc. ):
| Responsible Party: | Vyluma, Inc. |
| ClinicalTrials.gov Identifier: | NCT03350620 |
| Other Study ID Numbers: |
CP-NVK002-0001 2018-001077-24 ( EudraCT Number ) |
| First Posted: | November 22, 2017 Key Record Dates |
| Last Update Posted: | January 5, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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child, myopia, nearsightedness |
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Myopia Refractive Errors Eye Diseases |