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?

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

Next Previous
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

Price :
$35 *
Note:
  • 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 (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.

You need to be a logged in or subscribed to view this content

Request demo (opens in a new window)
If your organization or you do not have a subscription, try one of the following: If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top