A Randomized, Double-Masked, Parallel-Group, Phenylephrine-Controlled Study of the Effect of OMS302 Added to Standard Irrigation Solution on Intraoperative Pupil Diameter and Acute Postoperative Pain in Children Ages Birth Through Three Years Undergoing Unilateral Cataract Extraction With or Without Lens Replacement
Phase of Trial: Phase III
Latest Information Update: 12 Dec 2017
At a glance
- Drugs Ketorolac/phenylephrine (Primary)
- Indications Cataracts; Postoperative pain
- Focus Adverse reactions; Registrational; Therapeutic Use
- Acronyms ILR7
- Sponsors Omeros Corporation
- 12 Dec 2017 According to an Omeros Corporation media release, based on the data of this trial, the company has approved a supplemental New Drug Application (sNDA) for OMIDRIA (phenylephrine and ketorolac intraocular solution) 1% / 0.3% to use in pediatric patients and an additional six months of U.S. market exclusivity..
- 21 Nov 2016 According to an Omeros Corporation media release, the FDA agreed that results from this trial can be extrapolated to patients through 18 years of age, and a label expansion would be expected to be applicable to that full age range.
- 21 Nov 2016 According to an Omeros Corporation media release, the company has submitted a supplemental New Drug Application (sNDA) that includes the full clinical study report and proposed labeling, thus fulfills the post-marketing requirement and results in eligibility for an additional 6 months of marketing exclusivity for OMIDRIA as well as label expansion to include information on dosing for pediatric patients.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History