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

Primary Purpose

Cataracts

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Moxifloxacin Ophthalmic
Besifloxacin Ophthalmic
Sponsored by
Bucci Laser Vision Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataracts

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Bucci Laser Vision Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

VIGAMOX

Besivance

Arm Description

Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection

Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2011
Last Updated
December 7, 2020
Sponsor
Bucci Laser Vision Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01296542
Brief Title
A Comparison of Prophylactic Antibacterial Efficacy of Besivance vs. VIGAMOX Prior to Cataract Surgery
Official Title
A Comparison of Prophylactic Antibacterial Efficacy of Besivance Versus VIGAMOX Administered for Three Days and One Hour Prior to Phacoemulsification
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bucci Laser Vision Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataracts

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VIGAMOX
Arm Type
Active Comparator
Arm Description
Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Arm Title
Besivance
Arm Type
Active Comparator
Arm Description
Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Intervention Type
Drug
Intervention Name(s)
Moxifloxacin Ophthalmic
Intervention Type
Drug
Intervention Name(s)
Besifloxacin Ophthalmic
Primary Outcome Measure Information:
Title
Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days
Description
Lid and Conjunctival cultures will be taken to measure bacterial colonization.
Time Frame
Following 3 days of antibiotic drops topically instilled

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank A. Bucci, Jr., MD
Organizational Affiliation
Bucci Laser Vision Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bucci Laser Vision Institute
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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