CHAMP: Study of NVK-002 in Children With Myopia

Vyluma

Status and phase: Completed; Phase 3

Conditions: Myopia

Treatments: Drug: NVK-002 Concentration 1; Drug: Placebo; Drug: NVK-002 Concentration 2

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03350620

CP-NVK002-0001

2018-001077-24 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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)

Enrollment: 670 patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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670 participants in 3 patient groups, including a placebo group

NVK-002 Concentration 1

Experimental group

Description:

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.

Treatment:

Drug: NVK-002 Concentration 1

NVK-002 Concentration 2

Experimental group

Description:

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.

Treatment:

Drug: NVK-002 Concentration 2

Vehicle (Placebo)

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo