Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
670 participants
INTERVENTIONAL
2017-11-20
2023-10-19
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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
DOUBLE
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.
Study Groups
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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 1
Study medication will be administered, once daily (QD)
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.
NVK-002 Concentration 2
Study medication will be administered, once daily (QD)
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
Placebo
Vehicle (placebo) will be administered, once daily (QD)
Interventions
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NVK-002 Concentration 1
Study medication will be administered, once daily (QD)
NVK-002 Concentration 2
Study medication will be administered, once daily (QD)
Placebo
Vehicle (placebo) will be administered, once daily (QD)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
3 Years
17 Years
ALL
No
Sponsors
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Syneos Health
OTHER
Vyluma, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Houman Hemmati, MD
Role: STUDY_DIRECTOR
Nevakar, Inc.
Locations
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Site #009
Tucson, Arizona, United States
Site #015
Berkeley, California, United States
Site #003
Fullerton, California, United States
Site #016
San Diego, California, United States
Site #005
Danbury, Connecticut, United States
Site #004
Maitland, Florida, United States
Site #024
Peoria, Illinois, United States
Site #006
Boston, Massachusetts, United States
Site #014
St 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 #018
Forest Grove, Oregon, United States
Site #011
Elkins Park, Pennsylvania, United States
Site #017
Lancaster, Pennsylvania, United States
Site #008
Memphis, Tennessee, United States
Site #007
San Antonio, Texas, United States
Site #012
Kirkland, Washington, United States
Site #020
Spokane, Washington, United States
Site #021
Madison, Wisconsin, United States
Site #104
Budapest, , Hungary
Site #101
Dublin, , Ireland
Site # 105
Rotterdam, , Netherlands
Site #107
Barcelona, , Spain
Site #103
Coleraine, , United Kingdom
Site #106
London, , United Kingdom
Countries
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References
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Zadnik K, Schulman E, Flitcroft I, Fogt JS, Blumenfeld LC, Fong TM, Lang E, Hemmati HD, Chandler SP; CHAMP Trial Group Investigators. Efficacy and Safety of 0.01% and 0.02% Atropine for the Treatment of Pediatric Myopia Progression Over 3 Years: A Randomized Clinical Trial. JAMA Ophthalmol. 2023 Oct 1;141(10):990-999. doi: 10.1001/jamaophthalmol.2023.2097.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2018-001077-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CP-NVK002-0001
Identifier Type: -
Identifier Source: org_study_id
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