Status:
COMPLETED
CHAMP: Study of NVK-002 in Children With Myopia
Lead Sponsor:
Vyluma, Inc.
Collaborating Sponsors:
Syneos Health
Conditions:
Myopia
Eligibility:
All Genders
3-17 years
Phase:
PHASE3
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 19 2023
Estimated Enrollment :
670 Patients enrolled
Trial Details
Trial ID
NCT03350620
Start Date
November 20 2017
End Date
October 19 2023
Last Update
November 27 2024
Active Locations (26)
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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