Childhood Atropine for Myopia Progression (CHAMP, version 2)

• Research type

  Research Study

• Full title

  Childhood Atropine for Myopia Progression (champ): a 3-arm randomized, double-masked, placebo-controlled, phase 3 study of Atropine Sulfate Ophthalmic solution 0.01% and 0.02%

• IRAS ID

  246397

• Contact name

  Kenneth Somberg

• Contact email

  ksomberg@nevakar.com

• Sponsor organisation

  Nevakar, Inc

• Eudract number

  2018-001077-24

• Clinicaltrials.gov Identifier

  NCT03350620

• Clinicaltrials.gov Identifier

  , N/A

• Duration of Study in the UK

  4 years, 4 months, 17 days

• Research summary

  This is a double-masked phase 3 study to evaluate efficacy and safety of eye drops (Atropine Sulfate Ophthalmic Solution or placebo) in children above age of 3 years old who have myopia (nearsightedness).
  Enrolment in EU will be limited to children 3 to 10 years old as the target for children over 10 years of age has been obtained.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  18/LO/1806

• Date of REC Opinion

  10 Dec 2018

• REC opinion

  Further Information Favourable Opinion