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

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

Official Title
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A Study to Evaluate the Safety of Besivance™ (Besifloxacin Ophthalmic Suspension) 0.6% Compared to Vehicle Following Three Times Daily(TID) Dosing for 7 Days

Conditions
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Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: Besivance
* Drug: Vehicle


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Besivance<br>besifloxacin ophthalmic suspension 0.6% | Drug: Besivance<br>* Ocular administration to affected eye for 7 days<br>|
| Placebo Comparator: Vehicle<br>Vehicle of Besivance | Drug: Vehicle<br>* Vehicle of Besivance administered to affected eye for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Treatment Emergent Adverse Events | Ocular Treatment-Emergent Adverse Events on the Study Eye | At each visit - 7 days | 
| Non-Ocular Treatment-Emergent Adverse Events | Non-Ocular Treatment-Emergent Adverse Events on the Study Eye | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Resolution | The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. Participants with non-missing data | Day 8 (Visit 2) | 
| Clinical Resolution | The absence of both conjunctival discharge and bulbar conjunctival injection, after seven days of treatment. | Day 11 (Visit 3) | 
| Microbial Eradication | The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment. | Days 8 (Visit 2) | 
| Microbial Eradication | The absence of all accepted ocular bacterial species that were present at or above threshold at baseline, after seven days of treatment. | Days 11 (Visit 3) | 
| Microbial Outcome With Clinical Resolution | At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline | Day 8 (Visit 2) | 
| Microbial Outcome With Clinical Resolution | At each follow-up visit for the accepted ocular bacterial species that were present at or above threshold at baseline | Day 11 (Visit 3) | 
| Individual Clinical Outcomes - Ocular Discharge | ocular conjunctival discharge measured as absent, mild, moderate or severe | At day 1 (Vist 1) | 
| Individual Clinical Outcomes - Ocular Discharge | ocular conjunctival discharge measured as absent, mild, moderate or severe | At day 8 (Vist 2) | 
| Individual Clinical Outcomes - Ocular Discharge | ocular conjunctival discharge measured as absent, mild, moderate or severe | At day 11 (Vist 3) | 
| Individual Clinical Outcomes - Bulbar Injection | Bulbar conjunctival injection measured as normal, mild, moderate or severe | At day 1 (Vist 1) | 
| Individual Clinical Outcomes - Bulbar Injection | Bulbar conjunctival injection measured as normal, mild, moderate or severe | At day 8 (Vist 2) | 
| Individual Clinical Outcomes - Bulbar Injection | Bulbar conjunctival injection measured as normal, mild, moderate or severe | At day 11 (Vist 3) |