Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose

July 3, 2006 updated by: Ophthalmic Consultants of Boston

Prospective Study Comparing the Effectiveness of Zymar and Vigamox for Preoperative Antibiotic Sterilization of the Ocular Surface After Loading Dose

The purpose of this study is to analyze the effect of Zymar and Vigamox on ocular surface bacteria. We believe that Zymar will eradicate more ocular surface bacteria than Vigamox.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Topical antibiotics are frequently used before surgical procedures with the intent of targetting and reducing the number of bacteria on the surface of the eye. These bacteria serve as potential sources for post-operative infection. One commonly used method is the administration of antibiotic drops 3 times: 1 hour prior to surgery at intervals of 5 minutes. Studies in the lab have shown that the preservative benzalkonium chloride 0.005%, part of the Zymar antibiotic drop preparation, allows the antibiotic to act more effectively than the antibiotic Vigamox, which does not include this preservative.

Comparison: The effect of Zymar antibiotic eye drops on conjunctival cultures compared to the effect of Vigamox on conjunctival cultures as measured by conjunctival cultures taken prior to treatment and then one hour after administration of eye drops 3 times, at 5 minute intervals.

Study Type

Interventional

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female 25 years of age or older
  • Informed consent
  • Likely to complete the entire course of the study

Exclusion Criteria:

  • Contraindications or known sensitivity to any component of the study medications
  • A subject on oral or topical antibiotics
  • A subject that has a condition (i.e. an uncontrolled systemic disease) or is in a situation which, in the investigator's opinion, may put the subject at significant risk, may confound the trial results, or may interfere significantly with the subject's participation in the trial.
  • Monocular subjects
  • Contact lens wearers
  • Subjects who regularly take eyedrops other than preservative free artificial tears
  • A subject with an eye infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evidence of growth and number of colonies of bacteria on chocolate agar prior to antibiotic administration, t=0 hrs
Evidence of growth and number of colonies of bacteria on blood agar prior to antibiotic administration, t=0 hrs
Evidence of growth and number of colonies of bacteria on chocolate agar post-antibiotic administration, t=1 hr
Evidence of growth and number of colonies of bacteria on blood agar post-antibiotic administration, t=1 hr

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ophthalmic Consultants of Boston

Collaborators

Allergan

Investigators

  • Principal Investigator: Michael B Raizman, B.A./M.D., Ophthalmic Consultants of Boston
  • Study Director: Sandra Y Cho, B.A./M.D., New England Eye Center/Tufts-New England Medical Center
  • Study Director: Rahul Mandiga, B.S., New England Eye Center/Tufts-New England Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2006

Study Completion

June 1, 2006

Study Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

July 3, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

July 4, 2006

Last Update Submitted That Met QC Criteria

July 3, 2006

Last Verified

June 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Allergan/Z101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Infection

Clinical Trials on Moxifloxacin ophthalmic solution 0.5%

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe