drugset / Trial / NCT01330355

Besifloxacin Ophthalmic Suspension Verses Gatifloxacin Ophthalmic Solution in Neonates With Bacterial Conjunctivitis

NCT01330355

Phase 3 Terminated 33 enrolled Bausch & Lomb Incorporated
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of this study is to evaluate the safety and efficacy of Besivance (besifloxacin 0.6%) ophthalmic suspension compared to gatifloxacin 0.3% ophthalmic solution when administered three times daily (TID) for seven days to neonatal subjects who are 31 days or younger on the day of randomization (Visit 1).

Timeline

Start
2011-05
Primary completion
2013-01
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Besifloxacin Small molecule 0.6 % Other
Comparator Gatifloxacin Small molecule 0.3 % Other