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

Phase 4

Completed

• Conditions: Cataracts
• Interventions: Drug: Moxifloxacin Ophthalmic; Drug: Besifloxacin Ophthalmic

• Registration Number: NCT01296542
• Lead Sponsor: Bucci Laser Vision Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-02-14
• Study First Submitted QC: 2011-02-14
• Study First Posted: 2011-02-15
• Study Start: 2011-05
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Results First Submitted: 2013-01-23
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-07
• Last Update Submitted: 2020-12-07
• Results First Posted: 2020-12-08
• Last Update Posted: 2020-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VIGAMOX	Moxifloxacin Ophthalmic	Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection
Besivance	Besifloxacin Ophthalmic	Subjects will self administer drops 4 times daily for 3 days and one drop prior to sample collection

Primary Outcome Measures

Name	Time	Method
Number of Subjects With a Change in Bacterial Colonization of Lid and Conjunctival Cultures After 3 Days	Following 3 days of antibiotic drops topically instilled	Lid and Conjunctival cultures will be taken to measure bacterial colonization.

Trial Locations

Locations (1)

Bucci Laser Vision Institute; 🇺🇸 Wilkes-Barre, Pennsylvania, United States