A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain

Trial Profile

A Phase 3, Double-Masked, Randomized, Controlled Study to Evaluate the Safety and Efficacy of KPI-121 1.0% Ophthalmic Suspension in Subjects With Postsurgical Inflammation and Pain

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Oct 2017

At a glance

  • Drugs Loteprednol etabonate (Primary)
  • Indications Inflammation; Pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Kala Pharmaceuticals
  • Most Recent Events

    • 25 Oct 2017 According to a Kala Pharmaceuticals media release, based on the data from this and another phase III trial, the company has submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for INVELTYSTM (KPI-121 1%), a topical twice-a-day product candidate for the treatment of inflammation and pain in patients who have undergone ocular surgery.
    • 15 Aug 2017 Status changed from active, no longer recruiting to completed.
    • 01 May 2017 Primary endpoint has been met. (Proportion of study eyes with complete resolution of ocular pain (grade = 0) in the study eye)
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