Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle

Phase 3

Completed

Brief Summary: The objective of this study is to evaluate the safety of Besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.

Recruitment & Eligibility

Inclusion Criteria

Subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye.
Subjects who are willing to discontinue contact lens wear for the duration of the study.
Subjects who are able and willing to comply with all treatment and follow- up/study procedures.

Exclusion Criteria

Subjects who have any uncontrolled systemic disease or debilitating disease.
Subjects with a known hypersensitivity or contraindications to Besivance, fluoroquinolones, or any of the ingredients in the study drugs.
Subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, NSAIDs, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy)
Subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study.
Subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication.
Subjects with suspected iritis.
Subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome.
Subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis.
Subjects who are immune compromised.

Arm && Interventions

Group	Intervention	Description
Vehicle	Vehicle	Vehicle of Besivance
Besivance	Besivance	besifloxacin ophthalmic suspension 0.6%

Primary Outcome Measures

Name	Time	Method
Ocular Treatment Emergent Adverse Events	At each visit - 7 days	Ocular Treatment-Emergent Adverse Events on the Study Eye
Non-Ocular Treatment-Emergent Adverse Events	7 days	Non-Ocular Treatment-Emergent Adverse Events on the Study Eye

Secondary Outcome Measures

Name	Time	Method
Clinical Resolution	Day 11 (Visit 3)	The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment.
Microbial Eradication	Days 11 (Visit 3)	The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment.
Microbial Outcome With Clinical Resolution	Day 11 (Visit 3)	At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline
Individual Clinical Outcomes - Ocular Discharge	At day 11 (Vist 3)	ocular conjunctival discharge measured as absent, mild, moderate or severe
Individual Clinical Outcomes - Bulbar Injection	At day 11 (Vist 3)	Bulbar conjunctival injection measured as normal, mild, moderate or severe