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

This study has been completed.
Ophthalmology Associates, St Louis
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Joseph Gira, M.D., Ophthalmology Consultants, Ltd. Identifier:
First received: October 17, 2011
Last updated: October 18, 2011
Last verified: December 2010
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.

Condition Intervention Phase
Corneal Health
Cataract Surgery
Drug: besivance
Drug: vigamox
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Ophthalmology Consultants, Ltd.:

Primary Outcome Measures:
  • corneal health [ Time Frame: through day 28 post op ]
    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)

Secondary Outcome Measures:
  • subject tolerance [ Time Frame: day - 3 through day 28 ]
    reported adverse events

Enrollment: 60
Study Start Date: September 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: besifloxacin ophthalmic suspension 0.6%

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01455233

United States, Missouri
Ophthalmology Associates
St. Louis, Missouri, United States, 63131
Ophthalmology Consultants, Ltd
St. Louis, Missouri, United States, 63131
Sponsors and Collaborators
Ophthalmology Consultants, Ltd.
Ophthalmology Associates, St Louis
Bausch & Lomb Incorporated
Principal Investigator: Ranjan Maholtra, MD Ophthalmology Associates
Principal Investigator: Joseph Gira, MD Ophthalmology Consultants
  More Information

Responsible Party: Joseph Gira, M.D., Principal Investigator, Ophthalmology Consultants, Ltd. Identifier: NCT01455233     History of Changes
Other Study ID Numbers: STB-01
Study First Received: October 17, 2011
Last Updated: October 18, 2011

Keywords provided by Ophthalmology Consultants, Ltd.:
ocular antibiotic
cataract surgery

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
7-(3-aminohexahydro-1H-azepin-1-yl)-8-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-3-quinolinecarboxylic acid
Ophthalmic Solutions
Anti-Infective Agents
Antitubercular Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Nucleic Acid Synthesis Inhibitors
Pharmaceutical Solutions processed this record on May 24, 2017