2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate that Besivance is equal to Vigamox in safety and tolerance when used prophylactically in subjects undergoing routine cataract surgery.

Detailed Description
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Subjects will be assigned to receive either Besivance or Vigamox (1:1) to be administered as 1 drop in the study eye 4 times daily starting 3 days prior to cataract surgery and continuing for 7 days post-operatively. Sixty subjects (30 from Ophthalmology Consultants and 30 from Ophthalmology Associates) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.

Official Title
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Phase IV Study: A Prospective Two-Site Study to Evaluate the Safety and Tolerance of Besivance Versus Vigamox Prophylactically Pre and Post Operatively in Subjects Undergoing Routine Cataract Surgery

Conditions
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Corneal Health, Cataract Surgery

Intervention / Treatment
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* Drug: besivance
* Drug: vigamox


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men or woen of any race, 18 years or older who have a cataract, and are planning to undergo cataract extraction by phacoemulsification with the implantation of a posterior chamber intraocular lens Study eye of patients who, in the opinion of the investigator, will experience improvement in visual acuity following surgery Patients who are able to understand and sign an informed consent form that has been approved by an IRB Exclusion Criteria: Planned multiple procedures during cataract/IOL implantation surgery. Note: A planned limbal relaxing incision may be performed for the correction of astigmatism Use of topical ocular or systemic antibiotics within 14 days prior to surgery and through study exit History of or Fuch's Corneal Endothelial Dystrophy Any ocular inflammation (aqueous cells or flare greater than Grade 0) or ocular pain in the study eye that is present during the baseline visit. Recent (within 6 months) ocular trama to the operative eye (this includes intraocular surgery) A history of chronic or recurrent inflammatory eye disease (eg, iritis, scleritis, uveitis, iridocyclitis, rubeosis iridis) in the operative eye Currently diagnosed uncontrolled glaucoma in the operative eye Congenital ocular anomaly (eg, aniridia, congenital cataract) in the operative eye A visually nonfunctional fellow eye defined as a best corrected visual acuity </= 35 ETDRS letters (20/200 Snellen equivalent) or worse Participation in any other investigational drug or device study within 30 days before cataract surgery Known or suspected allergy or hypersensitivity to any component of either test article Women of childbearing potential (those who are not surgically sterilized or post menopausal) may not participate in the study if any of the following conditions exist: they are breast feeding they have a positive urine pregnancy test at screening they are not willing to undergo a urine pregnancy test upon entering or exiting the study they intend to become pregnant during the duration of the study; or, they do not agree to use adequate birth control methods for the duration of the study

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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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: besivance<br>ocular antibiotic | Drug: vigamox<br>* topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery<br>* Other names: moxifloxacin hydrochloride ophthalmic solution 0.5%;|
| Active Comparator: vigamox<br>ocular antibiotic | Drug: besivance<br>* topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery<br>* Other names: besifloxacin ophthalmic suspension 0.6%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| corneal health | Endothelial Cell Count (day 7, day 28) Pachymetry (day 7, day 28) Corneal Fluorescein Staining (day 7, day 28) Biomicroscopy (day 1, day 7, day 28) | through day 28 post op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subject tolerance | reported adverse events | day - 3 through day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cornea, ocular antibiotic, cataract surgery