A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus

Trial Profile

A Phase III, Multi-center Study to Evaluate the Safety and Efficacy of Epithelium-on Corneal Collagen Cross-linking in Eyes With Progressive Keratoconus

Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2018

At a glance

  • Drugs Riboflavin (Primary)
  • Indications Keratoconus
  • Focus Registrational; Therapeutic Use
  • Sponsors Avedro
  • Most Recent Events

    • 05 Apr 2018 Status changed from not yet recruiting to recruiting.
    • 15 Mar 2018 According to an Avedro media release, if trial objectives met this study would form the primary basis of a regulatory submission to obtain FDA approval of Avedros epi-on cross-linking treatment.
    • 15 Mar 2018 According to an Avedro media release, the company has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA).
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