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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
33
Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
Bausch & Lomb Incorporated
Bridgewater, New Jersey, United States
Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time frame: Visit 5 (Day 8+1)
Clinical Resolution
Clinical resolution defined as the absence of both conjunctival discharge and conjunctival hyperemia.
Time frame: Visit 3 (Day 3)
Microbial Eradication
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
Time frame: Visit 5 (Day 8+1)
Microbial Outcome
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
Time frame: Visit 3 (Day 3) and Visit 5 (Day 8+1)
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