A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery

Study Overview
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Brief Summary
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To compare antibacterial efficacy of Besivance versus VIGAMOX for decreasing bacteria of the conjunctiva and lid margins in cataract patients prior to surgery after both 1 hour and 3 days of treatment.

Official Title
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A Comparison of Prophylactic Antibacterial Efficacy of Besivance Versus VIGAMOX Administered for Three Days and One Hour Prior to Phacoemulsification

Conditions
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Cataracts

Intervention / Treatment
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* Drug: Moxifloxacin Ophthalmic
* Drug: Besifloxacin Ophthalmic


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman 18 years of age or older. Physically capable of instilling eye drop or have an appropriate person available to assist in administration of eye drops 4 times a day. Scheduled for phacoemulsification with intraocular lens (IOL) implantation for the treatment of cataract. Meet the American Society of Anesthesiology (ASA) physical status I, II, or III and be medically cleared for surgery. Willing to adhere to the prohibitions and restrictions specified in this protocol. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Exclusion Criteria: Known allergy or contraindication to the test article(s) or their components. Presence of any abnormality or significant illness in the eye that in the investigator's opinion could affect the subject's health or the study parameters. Presence of an active ocular infection (bacterial, viral or fungal), or positive history of ocular herpetic infection. History of any significant illness that could be expected to interfere with the study parameters. Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study. Use of disallowed therapies (systemic or topical): Fluoroquinolone anti-infective agents (systemic or topical) within 1 week of Visit 1 or anytime after Visit 1 for the duration of the study. Use of contact lenses for one week prior to the study and for the duration of the study. Received an experimental drug or used an experimental medical device within 21 days before the planned start of treatment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VIGAMOX<br>Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection | Drug: Moxifloxacin Ophthalmic<br> <br> |
| Active Comparator: Besivance<br>Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection | Drug: Besifloxacin Ophthalmic<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days | Lid and Conjunctival cultures will be taken to measure bacterial colonization. | Following 3 days of antibiotic drops topically instilled |