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

• Status: Terminated
• Trial end date: 2013-10-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch & Lomb Incorporated
• Treatments: 7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid; Besifloxacin; Fluoroquinolones; Gatifloxacin; Ophthalmic Solutions; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Subjects who have a clinical diagnosis of acute bacterial conjunctivitis and exhibit conjunctival discharge and redness in at least one eye. A minimum score of 1 should be present for discharge and a minimum score of 1 for conjunctival hyperemia in the same eye.

Exclusion Criteria:

• Subjects with conjunctivitis signs and/or symptoms suggestive of fungal, protozoal, or viral etiology in either eye.

• Subjects who require or are expected to require (other than study medication) use of any topical ocular medication in either eye, or systemic medications during the course of the study or prior to Day 1 specified in the protocol as ineligible.

• Subjects with any abnormality of the ocular anatomy or ocular disease/disorder specified in the protocol as ineligible.

• Subjects with systemic disease/disorder specified in the protocol as ineligible.

• Subjects who have a known or suspected poor tolerance, sensitivity, or allergy to the study medications or any of their components.

• Subjects who have a condition or are in a situation which in the investigator's opinion may impact their safety or would negatively affect the conduct or outcome of the study.