CHAMP: Study of NVK-002 in Children With Myopia

Sponsor

Vyluma, Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT03350620

Collaborator

Syneos Health (Other)

576

Enrollment

Locations

Arms

68.5

Anticipated Duration (Months)

22.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Drug: NVK-002 Concentration 1 Drug: NVK-002 Concentration 2 Drug: Placebo	Phase 3

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 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 Design

Study Type:

Interventional

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.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 :

Nov 20, 2017

Anticipated Primary Completion Date :

Aug 7, 2022

Anticipated Study Completion Date :

Aug 7, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 Names: NVK-002 Conc 1
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 Names: NVK-002 Conc 2
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 Names: Vehicle

Arm

Intervention/Treatment

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 Names:

NVK-002 Conc 1

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 Names:

NVK-002 Conc 2

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 Names:

Vehicle

Outcome Measures

Primary Outcome Measures

The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit. [36 Months]
The overall between-group difference in proportion of subjects who show < -0.50 D myopia progression (SER) at the Month 36 visit.

Secondary Outcome Measures

Between-group difference in mean progression rates. [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. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Site #009	Tucson	Arizona	United States	85711
2	Site #015	Berkeley	California	United States	94720
3	Site #003	Fullerton	California	United States	92831
4	Site #016	San Diego	California	United States	92129
5	Site #005	Danbury	Connecticut	United States	06810
6	Site #004	Maitland	Florida	United States	32751
7	Site #024	Peoria	Illinois	United States	61615
8	Site #006	Boston	Massachusetts	United States	02115
9	Site #014	Saint Louis	Missouri	United States	63110
10	Site #002	New York	New York	United States	10036
11	Site #013	Raleigh	North Carolina	United States	27603
12	Site #001	Columbus	Ohio	United States	43210
13	Site #018	Forest Grove	Oregon	United States	97116
14	Site #011	Elkins Park	Pennsylvania	United States	19027
15	Site #017	Lancaster	Pennsylvania	United States	17601
16	Site #008	Memphis	Tennessee	United States	38104
17	Site #007	San Antonio	Texas	United States	78240
18	Site #012	Kirkland	Washington	United States	98034
19	Site #020	Spokane	Washington	United States	99204
20	Site #021	Madison	Wisconsin	United States	53705
21	Site #104	Budapest		Hungary	H - 1085
22	Site #101	Dublin		Ireland	D07 H6K8
23	Site # 105	Rotterdam		Netherlands	3015 AA
24	Site #107	Barcelona		Spain	8950
25	Site #103	Coleraine		United Kingdom	BT52 1HS
26	Site #106	London		United Kingdom	EC1V 2PD

Sponsors and Collaborators

Vyluma, Inc.
Syneos Health

Investigators

Study Director: Houman Hemmati, MD, Nevakar, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Vyluma, Inc.

ClinicalTrials.gov Identifier:

NCT03350620

Other Study ID Numbers:

CP-NVK002-0001
2018-001077-24

First Posted:

Nov 22, 2017

Last Update Posted:

Mar 10, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Vyluma, Inc.

child, myopia, nearsightedness

Additional relevant MeSH terms:

Myopia

Study Results

No Results Posted as of Mar 10, 2022