2-Site Safety Study of Besivance Versus Vigamox Prophylactically in Routine Cataract Surgery (STB-01)

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

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.

Study Overview

• Status: Completed
• Conditions: Cataract Surgery; Corneal Health
• Intervention / Treatment: Drug: vigamox; Drug: besivance

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63131
      • Ophthalmology Associates
    • St. Louis, Missouri, United States, 63131
      • Ophthalmology Consultants, Ltd

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

  1. they are breast feeding
  2. they have a positive urine pregnancy test at screening
  3. they are not willing to undergo a urine pregnancy test upon entering or exiting the study
  4. they intend to become pregnant during the duration of the study; or,
  5. they do not agree to use adequate birth control methods for the duration of the study

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ophthalmology Consultants, Ltd.
• Collaborators: Bausch & Lomb Incorporated; Ophthalmology Associates, St Louis
• Investigators: Principal Investigator: Ranjan Maholtra, MD, Ophthalmology Associates; Principal Investigator: Joseph Gira, MD, Ophthalmology Consultants

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: October 17, 2011
• First Submitted That Met QC Criteria: October 18, 2011
• First Posted (Estimate): October 19, 2011

Study Record Updates

• Last Update Posted (Estimate): October 19, 2011
• Last Update Submitted That Met QC Criteria: October 18, 2011
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: cataract surgery; cornea; ocular antibiotic
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Contraceptive Agents, Hormonal; Contraceptive Agents; Reproductive Control Agents; Contraceptives, Oral, Combined; Contraceptives, Oral; Contraceptive Agents, Female; Pharmaceutical Solutions; Moxifloxacin; Norgestimate, ethinyl estradiol drug combination; Ophthalmic Solutions; Besifloxacin
• Other Study ID Numbers: STB-01