A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3C Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Trial Profile

A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3C Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2017

At a glance

  • Drugs Dexamethasone (Primary)
  • Indications Ocular inflammation; Ocular pain; Postoperative inflammation; Postoperative pain
  • Focus Therapeutic Use
  • Sponsors Ocular Therapeutix
  • Most Recent Events

    • 11 May 2017 According to an Ocular Therapeutix media release, subject to the approval of the NDA for post-surgical ocular pain by the FDA (based on a phase 2 study-NCT01666210 and two phase 3 trials-NCT02034019,NCT02089113), the company intends to submit a supplement to its NDA for DEXTENZA to broaden its label to include a post-surgical ocular inflammation indication, based on the results of this third phase 3 study.
    • 11 May 2017 According to an Ocular Therapeutix media release, results of the pooled analysis from three phase 3 clinical trials evaluating the integrated efficacy and safety of DEXTENZA (NCT02089113, NCT02034019 and NCT02736175), presented at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (2017).
    • 11 May 2017 Results of the pooled analysis from three phase 3 clinical trials evaluating the integrated efficacy and safety of DEXTENZA (NCT02089113, NCT02034019 and NCT02736175), published in an Ocular Therapeutix Media Release.
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