NCT04539548

A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract

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: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Ocular Therapeutix, Inc. · Industry
• Sex: All
• Age: 0 Years – 5 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.

Conditions

• Cataract

Interventions

Type	Name	Description
DRUG	Dextenza Ophthalmic Insert	0.4mg insert for intracanalicular use
DRUG	Prednisolone acetate ophthalmic suspension USP 1%	1 drop at end of surgery, followed by: 1 drop 4 x QID for one week. 1 drop 3 x QID for one week. 1 drop BID for one week. 1 drop QD for one week

Timeline

• Start date: 2020-09-04
• Primary completion: 2023-12-21
• Completion: 2023-12-21
• First posted: 2020-09-07
• Last updated: 2024-04-15

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study