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Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

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Trial Profile

Loteprednol Etabonate Ophthalmic Gel, 0.38% (BID and TID) Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Sep 2020

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At a glance

  • Drugs Loteprednol etabonate (Primary)
  • Indications Ocular inflammation; Ocular pain
  • Focus Registrational; Therapeutic Use
  • Sponsors Bausch & Lomb
  • Most Recent Events

    • 25 Feb 2019 Results of two phase III studies (NCT01996839 and NCT02208297) in 742 patients with postoperative inflammation following cataract surgery presented in a Bausch and Lomb media release.
    • 25 Feb 2019 According to a Bausch and Lomb media release, based on data from two randomized, multicenter, double-masked, parallel-group, vehicle-controlled studies (NCT01996839 and NCT02208297) in 742 patients with postoperative inflammation following cataract surgery, the U.S. FDA has approved LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38%, a new gel formulation for the treatment of postoperative inflammation and pain following ocular surgery.
    • 05 Sep 2018 According to a Bausch & Lomb media release, based on the data of this and other study (248052), the U.S. Food and Drug Administration has accepted the New Drug Application for submicron loteprednol etabonate ophthalmic gel, 0.38% with a Prescription Drug User Fee Act (PDUFA) action date of Feb. 25, 2019.
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