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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Bucci Laser Vision Institute.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bucci Laser Vision Institute
ClinicalTrials.gov Identifier:
NCT01296542
First received: February 14, 2011
Last updated: July 11, 2011
Last verified: July 2011
  Purpose

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.


Condition Phase
Cataracts
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Comparison of Prophylactic Antibacterial Efficacy of Besivance Versus VIGAMOX Administered for Three Days and One Hour Prior to Phacoemulsification

Resource links provided by NLM:


Further study details as provided by Bucci Laser Vision Institute:

Primary Outcome Measures:
  • Lid and Conjunctival cultures will be taken to measure bacterial colonization. [ Time Frame: Following 3 days of antibiotic drops topically instilled ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
VIGAMOX
Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Besivance
Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Subjects with scheduled cataract surgery, men and women, 18 years of age and older.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01296542

Contacts
Contact: Ruth Evans, C.O.T. 570-825-5949 Ruth@buccivision.com
Contact: Barbara Michalek 570-825-5949 Barb@buccivision.com

Locations
United States, Pennsylvania
Bucci Laser Vision Institute Recruiting
Wilkes-Barre, Pennsylvania, United States, 18702
Contact: Ruth Evans    570-825-5949    Ruth@buccivision.com   
Contact: Barbara Michalek    570-825-5949    Barb@buccivision.com   
Principal Investigator: Frank A. Bucci, Jr., MD         
Sponsors and Collaborators
Bucci Laser Vision Institute
Investigators
Principal Investigator: Frank A. Bucci, Jr., MD Bucci Laser Vision Institute
  More Information

No publications provided

Responsible Party: Frank A. Bucci, Jr., MD, Bucci Laser Vision Institute
ClinicalTrials.gov Identifier: NCT01296542     History of Changes
Other Study ID Numbers: 2011-BV-C
Study First Received: February 14, 2011
Last Updated: July 11, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cataract
Lens Diseases
Eye Diseases
Anti-Bacterial Agents
Besifloxacin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 31, 2014