Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04539548 | A Study Assessing the Safety and Efficacy of Dextenza® for the Treatment of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract | PHASE3 | COMPLETED | 65 | — | — | Sep 4, 2020 | Dec 21, 2023 | Apr 15, 2024 | 14 | United States |
Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs)
Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain).
IOP measured in units of mmHg.
| Arm | Type | Description |
|---|---|---|
| Dextenza | EXPERIMENTAL | 1 dosing group - 37 eyes treated with Dextenza |
| Prednisolone | ACTIVE_COMPARATOR | 1 dosing group - 32 eyes treated with Prednisolone |
| Name | Type | Description |
|---|---|---|
| Dextenza Ophthalmic Insert | DRUG | 0.4mg insert for intracanalicular use |
| Prednisolone acetate ophthalmic suspension USP 1% | DRUG | 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 |
Inclusion Criteria: * Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for particip...