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

NCT01296542 | Completed Phase 4 Results DMC

• 1 other identifier: 2011-BV-C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

VIGAMOX

ACTIVE COMPARATOR

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

Drug: Moxifloxacin Ophthalmic

Besivance

ACTIVE COMPARATOR

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

Drug: Besifloxacin Ophthalmic

Interventions

Moxifloxacin Ophthalmic DRUG

VIGAMOX

Besifloxacin Ophthalmic DRUG

Besivance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bucci Laser Vision Institute: lead

Study Sites (1)

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, 18702, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Results Point of Contact

• Title: Frank A. Bucci Jr., MD
• Organization: Bucci Laser Vision

buccivision@aol.com

570-825-5949

Study Officials

• Frank A. Bucci, Jr., MD

  Bucci Laser Vision Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 14, 2011
• First Posted: February 15, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: December 8, 2020
• Results First Posted: December 8, 2020

Record last verified: 2020-12

Locations

US (1)