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.
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