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

• Clinical Resolution [ Time Frame: Visit 3 (Day 3) ] [ Designated as safety issue: No ]
  Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
• Microbial Eradication [ Time Frame: Visit 5 (Day 8+1) ] [ Designated as safety issue: No ]
  Eradication defined as the absence of all accepted ocular bacterial species (as measured on the ordinal scale) that were present at or above threshold at baseline
• Signs of Bacterial Conjunctivitis [ Time Frame: At each visit for 7 days ] [ Designated as safety issue: No ]
  Ocular discharge rated on a scale from 0(none), 1(mild), 2(moderate) to 3(severe) Conjunctiva hyperemia rated on a scale from 0(normal), 1(mild), 2(moderate) to 3(severe)
• Microbial Outcome [ Time Frame: Visit 3 (Day 3) and Visit 5 (Day 8+1) ] [ Designated as safety issue: No ]

  Microbial outcome for the following groups of accepted ocular bacterial species that were present at or above threshold at baseline:

  • over all bacterial species
  • over all and individual gram-positive bacterial species
  • over all and individual gram-negative bacterial species

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).

• 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

• Experimental: Besivance
  Besifloxacin 0.6% ophthalmic suspension
  Intervention: Drug: Besivance
• Active Comparator: Gatifloxacin
  Gatifloxacin 0.3% ophthalmic solution
  Intervention: Drug: Gatifloxacin

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.