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

Primary Purpose

Eye Infection, Infection

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Moxifloxacin ophthalmic solution 0.5%
Gatifloxacin ophthalmic solution 0.3%
Sponsored by
Ophthalmic Consultants of Boston
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Eye Infection focused on measuring Antibiotic prophylaxis, Vigamox, Moxifloxacin, Zymar, Gatifloxacin, Preoperative antibiotic, Eye infection

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Ophthalmic Consultants of Boston

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 30, 2006
Last Updated
July 3, 2006
Sponsor
Ophthalmic Consultants of Boston
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00347828
Brief Title
Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose
Official Title
Prospective Study Comparing the Effectiveness of Zymar and Vigamox for Preoperative Antibiotic Sterilization of the Ocular Surface After Loading Dose
Study Type
Interventional

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Unknown status
Study Start Date
June 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Ophthalmic Consultants of Boston
Collaborators
Allergan

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Infection, Infection
Keywords
Antibiotic prophylaxis, Vigamox, Moxifloxacin, Zymar, Gatifloxacin, Preoperative antibiotic, Eye infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Double
Allocation
Randomized
Enrollment
40 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Moxifloxacin ophthalmic solution 0.5%
Intervention Type
Drug
Intervention Name(s)
Gatifloxacin ophthalmic solution 0.3%
Primary Outcome Measure Information:
Title
Evidence of growth and number of colonies of bacteria on chocolate agar prior to antibiotic administration, t=0 hrs
Title
Evidence of growth and number of colonies of bacteria on blood agar prior to antibiotic administration, t=0 hrs
Title
Evidence of growth and number of colonies of bacteria on chocolate agar post-antibiotic administration, t=1 hr
Title
Evidence of growth and number of colonies of bacteria on blood agar post-antibiotic administration, t=1 hr

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Raizman, B.A./M.D.
Organizational Affiliation
Ophthalmic Consultants of Boston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandra Y Cho, B.A./M.D.
Organizational Affiliation
New England Eye Center/Tufts-New England Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Rahul Mandiga, B.S.
Organizational Affiliation
New England Eye Center/Tufts-New England Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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