A 3-Arm Randomized, Double-Masked, Placebo-Controlled, Phase 3 Study of NVK-002 in Children With Myopia
Status: Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 01 Nov 2019
Price : $35 *
At a glance
- Drugs Atropine (Primary)
- Indications Myopia
- Focus Registrational; Therapeutic Use
- Acronyms CHAMP
- Sponsors Nevakar
- 23 Sep 2019 Planned End Date changed from 1 Nov 2022 to 1 Aug 2023.
- 23 Sep 2019 Planned primary completion date changed from 1 Nov 2021 to 1 Aug 2022.
- 11 Sep 2019 According to a Nevakar media release, management of Nevakar has held extensive discussions with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the protocol and study design and believes there is a clear path forward to regulatory submission in both the United States and in Europe. Regulatory filing can take place after the 3-year endpoint has been reached.