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

Cataracts Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01296542
• Other study ID #: 2011-BV-C
• Status: Completed
• Phase: Phase 4
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: December 2020
• Source: Bucci Laser Vision Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataracts

Intervention

Drug:
• Moxifloxacin Ophthalmic

• Besifloxacin Ophthalmic

Locations

Country	Name	City	State
United States	Bucci Laser Vision Institute	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bucci Laser Vision Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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