CLN-0500

Actively Recruiting // Clinical Trials // Congenital Cataract // Michael Struck // Pediatrics // Aug 24 2021

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

  • Sponsor: Ocular Therapeutix, Inc.
  • Principal Investigator: Michael Struck
  • Study Coordinator: Kris Dietzman

Study objective:

To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following pediatric cataract surgery.

Study design:

Subjects will be randomized to be treated with either Dextenza or prednisolone acetate suspension. There are 7 study visits over a period of 2-3 months.

Inclusion criteria:

  • Pediatric cataract diagnosis
  • Subject is >0 – 3 years of age

Exclusion criteria:

  • Any intraocular inflammation in the study eye
  • Ocular hypertension or glaucoma
  • Evidence of acute external ocular infections

Contact Kris Dietzman with questions, (608) 263-9035.

For more information about this study, visit:

clinicaltrials.gov