Phase 3
N=576
CHAMP: Study of NVK-002 in Children With Myopia
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT03350620 ↗Enrolled (actual)
576
Serious AEs
2.0%
Results posted
Nov 2024
Primary outcome: Primary: Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit — 79; 106; 61 participants' eyes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- NVK-002 Concentration 1 (Drug); NVK-002 Concentration 2 (Drug); Placebo (Drug)
- Age
- Pediatric · 3+ yrs
- Sex
- All
- Sponsor
- Vyluma, Inc.
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects' Eyes That Show < 0.50 D Myopia Progression (SER, Spherical Equivalent Refraction) at the Month 36 Visit |
79; 106; 61 | — |
| SECONDARY Change From Baseline in SER (Spherical Equivalent Refraction) |
-0.85; -1.02; -1.10 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
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.
Data sourced from ClinicalTrials.gov (NCT03350620). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.