Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% Versus Vehicle Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

Next Previous
Trial Profile

Study to Assess Loteprednol Etabonate Ophthalmic Gel, 0.38% 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

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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 (239407), 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.
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Legal
Back to top