drugset / Trial / NCT01028027

Loteprednol and Tobramycin Versus Tobramycin and Dexamethasone, in the Treatment of Blepharokeratoconjunctivitis

NCT01028027 ↗

Phase 3 Completed 357 enrolled Bausch & Lomb Incorporated
RandomizedParallel-groupSingle-blindTreatment

Summary

This study is to evaluate the safety and efficacy of loteprednol etabonate \[LE\] and tobramycin ophthalmic suspension versus tobramycin and dexamethasone ophthalmic suspension in the treatment of ocular inflammation associated with blepharokeratoconjunctivitis (BKC).

Timeline

Start
2009-10
Primary completion
2010-02
Completion
2010-03

Outcome

Met primary endpoint

paper the upper bound of the 90% confidence interval for the difference was less than the prespecified non-inferiority margin. PMID 22256909 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 0.1 % Topical
Subject Loteprednol Etabonate Other / unclassified 0.5 % Topical
Comparator Tobramycin Unknown 0.3 % Topical