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

NCT ID: NCT01296542

Last Updated: 2020-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-01-31

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.

Conditions

Cataracts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VIGAMOX

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

Group Type: ACTIVE_COMPARATOR

Moxifloxacin Ophthalmic

Intervention Type: DRUG

Besivance

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

Group Type: ACTIVE_COMPARATOR

Besifloxacin Ophthalmic

Intervention Type: DRUG

Interventions

Moxifloxacin Ophthalmic

Intervention Type: DRUG

Besifloxacin Ophthalmic

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Bucci Laser Vision Institute

OTHER

Sponsor Role: lead

Responsible Party

Frank A. Bucci, Jr., M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank A. Bucci, Jr., MD

Role: PRINCIPAL_INVESTIGATOR

Bucci Laser Vision Institute

Locations

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, United States

Countries

United States

Other Identifiers

2011-BV-C

Identifier Type: -

Identifier Source: org_study_id