drugset / Trial / NCT03739528

Levo-Dexa vs. Tobra+Dexa for Prevention and Treatment of Inflammation and Prevention of Infection in Cataract Surgery

NCT03739528

Phase 3 Completed 808 enrolled NTC srl
RandomizedParallel-groupSingle-blindPrevention

Summary

The purpose of this study is to demonstrate the non-inferiority of the study treatment (combined levofloxacin + dexamethasone eye drops) followed by dexamethasone eye drops alone vs. standard treatment in the prevention and treatment of postoperative ocular inflammation and prevention of infection.

Timeline

Start
2018-09-03
Primary completion
2018-12-19
Completion
2018-12-19

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 1 mg/ml Other
Subject Levofloxacin Small molecule 5 mg/ml Other
Comparator Tobramycin Small molecule Other

Indications