Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis
Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis
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.
Inclusion Criteria:

 -  Have a clinical diagnosis of acute bacterial conjunctivitis and exhibit
 mucopurulent/purulent conjunctival discharge (crusty or sticky eyelids) and redness in
 at least 1 eye. A minimum score of 1 should be present for both discharge and for
 bulbar conjunctival injection.

 -  Have monocular pin-holed Snellen visual acuity (VA) equal to or better than 20/200 in
 both eyes. Age appropriate VA testing will be performed. Every effort should be made
 to obtain a VA measurement in children. If VA is unobtainable in children, it is at
 the Investigator's discretion to include the subject in the study.

 -  Be willing to discontinue contact lens wear for the duration of the study.

 Exclusion Criteria:

 -  Have a severe/serious ocular condition or history/presence of chronic generalized
 systemic disease that the Investigator feels might increase the risk to the subject or
 confound the result(s) of the study.

 -  Have a known hypersensitivity or contraindications to besifloxacin, fluoroquinolones,
 or any of the ingredients in the study drugs.

 -  Be expected to require treatment with systemic or ocular (either eye) nonsteroidal
 anti-inflammatory drugs (NSAIDs), antihistamines, or corticosteroids during the study
 or have used any of these medications within 2 days prior to study start.

 -  Be expected to require concurrent ocular therapy in either eye with any ophthalmic
 solutions (unless specified below), including tear substitutes, during the study or
 have used any ophthalmic solutions within 2 hours prior to study start. Be expected to
 require concurrent ocular therapy (either eye) with mast cell stabilizers or
 decongestants during the study or have used any of the above within 2 days prior to
 study start.

 -  Be expected to require concurrent systemic or ocular therapy with immunosuppressants
 (eg, Restasis) during the study or have used systemic or ocular immunosuppressants
 within 30 days prior to study start.

 -  Be expected to require treatment with systemic or ocular (either eye) antibacterials
 (other than study drug) during the study or have used any systemic or ocular
 antibacterial within 3 days prior to study start.

 -  Be likely to require antimicrobial therapy for conditions such as respiratory tract
 infection, urinary tract infection, skin/soft tissue infection, or otitis media during
 the study.

 -  Have had ocular surgery (including laser surgery) in either eye within 6 weeks prior
 to entry into this study.

 -  Have suspected viral or allergic conjunctivitis or any other disease conditions that
 could interfere with the efficacy and safety evaluations of the study medication.

 -  Have suspected iritis

 -  Have a history of recurrent corneal erosion syndrome, either idiopathic or secondary
 to previous corneal trauma or dry eye syndrome.

 -  Have any active ulcerative keratitis, specifically any epithelial loss greater than
 punctate keratitis.

 -  Be immune compromised.