This is a study to investigate a novel drug candidate for the treatment of bacterial conjunctivitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
1,161
Besifloxacin hydrochloride ophthalmic suspension, 0.6% as base, administered TID for 5 days
Moxifloxacin hydrochloride ophthalmic solution 0.5% administered TID for 5 days.
Clinical Resolution
Resolution of conjunctival discharge and bulbar conjunctival injection. (mITT, culture confirmed, as treated)
Time frame: Day 5(+/- 1 day)
Microbial Eradication
eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time frame: Day 5 (+/- 1 day)
Clinical Resolution
Clinical resolution of conjunctival discharge and bulbar conjunctival injection, modified intent to treat (mITT), culture confirmed, as treated
Time frame: Day 8 or Day 9
Microbial Eradication
Microbial eradication of baseline bacterial infection. modified intent to treat (mITT), culture confirmed, as treated
Time frame: Day 8 or Day 9
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