drugset / Trial / NCT05620901
DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
RandomizedParallel-groupOpen-labelTreatment
Summary
The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery or laser treatment under anesthesia.
Timeline
- Start
- 2023-02-01
- Primary completion
- 2025-02-11
- Completion
- 2025-02-24
Outcome
Missed primary endpoint
registry analysis (superiority test); Dextenza Arm vs Control Arm (Steroid Drops); p = 0.3046 NCT05620901 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dexamethasone | Small molecule | 0.4 mg | Other |
| Comparator | Prednisolone | Other / unclassified | 1 % | Topical |