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

Information source: Bucci Laser Vision Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cataracts

Phase: Phase 4

Status: Recruiting

Sponsored by: Bucci Laser Vision Institute

Official(s) and/or principal investigator(s):
Frank A. Bucci, Jr., MD, Principal Investigator, Affiliation: Bucci Laser Vision Institute

Overall contact:
Ruth Evans, C.O.T., Phone: 570-825-5949, Email: Ruth@buccivision.com


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.

Clinical Details

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

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Lid and Conjunctival cultures will be taken to measure bacterial colonization.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- Received an experimental drug or used an experimental medical device within 21 days

before the planned start of treatment.

Locations and Contacts

Ruth Evans, C.O.T., Phone: 570-825-5949, Email: Ruth@buccivision.com

Bucci Laser Vision Institute, Wilkes-Barre, Pennsylvania 18702, United States; Recruiting
Ruth Evans, Phone: 570-825-5949, Email: Ruth@buccivision.com
Barbara Michalek, Phone: 570-825-5949, Email: Barb@buccivision.com
Frank A. Bucci, Jr., MD, Principal Investigator
Additional Information

Starting date: May 2011
Last updated: July 11, 2011

Page last updated: August 23, 2015

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