A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

Trial Profile

A Phase 3, Double-Masked, Randomized, Controlled Study of KPI-121 0.25% Ophthalmic Suspension Compared to Vehicle in Subjects With Dry Eye Disease

Completed
Phase of Trial: Phase III

Latest Information Update: 26 Mar 2018

At a glance

  • Drugs Loteprednol etabonate (Primary)
  • Indications Dry eyes
  • Focus Registrational; Therapeutic Use
  • Acronyms STRIDE 2
  • Sponsors Kala Pharmaceuticals
  • Most Recent Events

    • 26 Mar 2018 According to a Kala Pharmaceuticals media release, the company has conducted additional analyses on a post-hoc basis of STRIDE 1, STRIDE 2 and Phase 2 data.
    • 26 Mar 2018 According to a Kala Pharmaceuticals media release, based on the positive data from STRIDE 1 and STRIDE 2 trials, the company has submitted and US FDA has accepted for review a New Drug Application (NDA) for INVELTYS for the treatment of inflammation and pain following ocular surgery.
    • 19 Jan 2018 Status changed from recruiting to completed.
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