To evaluate the clinical and microbial efficacy of besifloxacin ophthalmic suspension, 0.6% (Besifloxacin) administered BID for 3 days compared to vehicle in the treatment of bacterial conjunctivitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
136
one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
Bausch & Lomb Incorporated
Rochester, New York, United States
Clinical Resolution
Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time frame: Visit 2 (Day 4 or 5)
Microbial Eradication
Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time frame: Visit 2 (Day 4 or 5)
Clinical Resolution
Absence of both conjunctival discharge and bulbar conjunctival injection, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time frame: Visit 3 (Day 6, 7, or 8)
Microbial Eradication
Absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after 3 days of treatment with besifloxacin ophthalmic suspension 0.6%
Time frame: Visit 3 (Day 6, 7, or 8)
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