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

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

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.

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Drug: Moxifloxacin Ophthalmic; Drug: Besifloxacin Ophthalmic

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

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wilkes-Barre, Pennsylvania, United States, 18702
      • Bucci Laser Vision Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bucci Laser Vision Institute
• Investigators: Principal Investigator: Frank A. Bucci, Jr., MD, Bucci Laser Vision Institute

Study record dates

Study Major Dates

• Study Start: May 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: February 14, 2011
• First Submitted That Met QC Criteria: February 14, 2011
• First Posted (Estimate): February 15, 2011

Study Record Updates

• Last Update Posted (Actual): December 8, 2020
• Last Update Submitted That Met QC Criteria: December 7, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Moxifloxacin; Besifloxacin
• Other Study ID Numbers: 2011-BV-C