Clinical and Microbial Efficacy of Besifloxacin Ophthalmic Suspension, 0.6% in the Treatment of Bacterial Conjunctivitis
Condition: Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Intervention: Besifloxacin; Vehicle
Intervention description: 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.
Intervention MeSH terms: Besifloxacin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 1 Year
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.