Trial Profile

A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 17 Apr 2024

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At a glance

Drugs Dexamethasone (Primary) ; Prednisolone acetate
Indications Ocular inflammation; Ocular pain; Postoperative inflammation; Postoperative pain
Focus Adverse reactions; Therapeutic Use
Sponsors Ocular Therapeutix

28 Feb 2024 Status changed from recruiting to completed.
10 Sep 2020 According to an Ocular Therapeutix media release, this trial is a post-approval requirement of the U.S. Food and Drug Administration, in accordance with the Pediatric Research Equity Act of 2003, in connection with the FDA's prior approval of DEXTENZA for the treatment of inflammation and pain following ophthalmic surgery in adults.
10 Sep 2020 According to an Ocular Therapeutix media release, it has dosed first patients in this trial.

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