Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose - Full Text View

Sponsors and Collaborators:	Ophthalmic Consultants of Boston Allergan
Information provided by:	Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier:	NCT00347828

Purpose

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.

Condition	Intervention	Phase
Eye Infection Infection	Drug: Moxifloxacin ophthalmic solution 0.5% Drug: Gatifloxacin ophthalmic solution 0.3%	Phase IV

MedlinePlus related topics: Antibiotics Eye Infections

Drug Information available for: Moxifloxacin Moxifloxacin hydrochloride Gatifloxacin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Prospective Study Comparing the Effectiveness of Zymar and Vigamox for Preoperative Antibiotic Sterilization of the Ocular Surface After Loading Dose

Further study details as provided by Ophthalmic Consultants of Boston:

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

Estimated Enrollment:	40
Study Start Date:	June 2006
Estimated Study Completion Date:	June 2006

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.

Eligibility

Ages Eligible for Study:	25 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347828

Locations

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

Sponsors and Collaborators

Ophthalmic Consultants of Boston

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

More Information

Study ID Numbers:	Allergan/Z101
Study First Received:	June 30, 2006
Last Updated:	July 3, 2006
ClinicalTrials.gov Identifier:	NCT00347828
Health Authority:	United States: Institutional Review Board

Keywords provided by Ophthalmic Consultants of Boston:

Antibiotic prophylaxis
Vigamox
Moxifloxacin
Zymar

Gatifloxacin
Preoperative antibiotic
Eye infection

Study placed in the following topic categories:

Fluoroquinolones
Moxifloxacin
Eye Diseases
Eye Infections
Gatifloxacin

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Communicable Diseases
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Enzyme Inhibitors
Infection
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009