CHAMP: Study of NVK-002 in Children With Myopia

Phase 3

Completed

• Conditions: Myopia
• Interventions: Drug: Placebo; Drug: NVK-002 Concentration 1; Drug: NVK-002 Concentration 2

• Registration Number: NCT03350620
• Lead Sponsor: Vyluma, Inc.

Brief 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.

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 Timeline

• Study First Submitted: 2017-11-16
• Study First Submitted QC: 2017-11-17
• Study Start: 2017-11-20
• Study First Posted: 2017-11-22
• Primary Completion: 2022-09-07
• Study Completion: 2023-10-19
• Results First Submitted: 2024-07-23
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-31
• Last Update Submitted: 2024-10-31
• Results First Posted: 2024-11-27
• Last Update Posted: 2024-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

1. Children aged 3 to ≤ 17.0 years.
2. 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

1. If present, astigmatism more than -1.50 D in either eye.
2. Current or history of amblyopia or strabismus.
3. History of any disease or syndrome that predisposes the subject to severe myopia (e.g., Marfan syndrome, Stickler syndrome, retinopathy of prematurity).
4. History in either eye of abnormal ocular refractive anatomy (e.g., keratoconus, lenticonus, spherophakia).
5. Serious systemic illness that, in the Investigator's opinion, would render the subject ineligible.
6. Chronic use (more than 3 days per week) of any topical ophthalmic medications (prescribed or over the-counter) other than the assigned study medication.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vehicle (Placebo)	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
NVK-002 Concentration 1	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.
NVK-002 Concentration 2	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Change From Baseline in SER (Spherical Equivalent Refraction)	Month 36	Change from baseline in SER (spherical equivalent refraction).

Trial Locations

Locations (26)

Site #003; 🇺🇸 Fullerton, California, United States

Site #009; 🇺🇸 Tucson, Arizona, United States

Site #005; 🇺🇸 Danbury, Connecticut, United States

Site #008; 🇺🇸 Memphis, Tennessee, United States

Site #015; 🇺🇸 Berkeley, California, United States

Site #016; 🇺🇸 San Diego, California, United States

Site #004; 🇺🇸 Maitland, Florida, United States

Site #024; 🇺🇸 Peoria, Illinois, United States

Site #006; 🇺🇸 Boston, Massachusetts, United States

Site #014; 🇺🇸 Saint Louis, Missouri, United States

Site #002; 🇺🇸 New York, New York, United States

Site #013; 🇺🇸 Raleigh, North Carolina, United States

Site #001; 🇺🇸 Columbus, Ohio, United States

Site #011; 🇺🇸 Elkins Park, Pennsylvania, United States

Site #018; 🇺🇸 Forest Grove, Oregon, United States

Site #017; 🇺🇸 Lancaster, Pennsylvania, United States

Site #007; 🇺🇸 San Antonio, Texas, United States

Site #012; 🇺🇸 Kirkland, Washington, United States

Site #104; 🇭🇺 Budapest, Hungary

Site #020; 🇺🇸 Spokane, Washington, United States

Site # 105; 🇳🇱 Rotterdam, Netherlands

Site #107; 🇪🇸 Barcelona, Spain

Site #021; 🇺🇸 Madison, Wisconsin, United States

Site #101; 🇮🇪 Dublin, Ireland

Site #103; 🇬🇧 Coleraine, United Kingdom

Site #106; 🇬🇧 London, United Kingdom