NCT01330355

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

Evaluation of the Safety and Efficacy of Topical Besifloxacin Ophthalmic Suspension, 0.6% Compared With Gatifloxacin, 0.3% Ophthalmic Solution for the Treatment of Presumed Bacterial Conjunctivitis in Subjects From Birth to 31 Days of Age

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 1 Day – 31 Days
• Healthy volunteers: Not accepted

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).

Conditions

• Bacterial Conjunctivitis

Interventions

Type	Name	Description
DRUG	Besivance	Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
DRUG	Gatifloxacin	Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-01-01
• Completion: 2013-10-01
• First posted: 2011-04-06
• Last updated: 2014-09-03
• Results posted: 2014-09-03

Locations

1 site across 1 country: United States