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

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00347828
• Other study ID #: Allergan/Z101
• Status: Active, not recruiting
• Phase: Phase 4
• First received: June 30, 2006
• Last updated: July 3, 2006
• Start date: June 2006
• Est. completion date: June 2006

Study information

• Verified date: June 2006
• Source: Ophthalmic Consultants of Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: June 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Communicable Diseases
• Eye Infection
• Eye Infections
• Infection

Intervention

Drug:
• Moxifloxacin ophthalmic solution 0.5%

• Gatifloxacin ophthalmic solution 0.3%

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Ophthalmic Consultants of Boston	Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evidence of growth and number of colonies of bacteria on chocolate agar prior to antibiotic administration, t=0 hrs
Primary	Evidence of growth and number of colonies of bacteria on blood agar prior to antibiotic administration, t=0 hrs
Primary	Evidence of growth and number of colonies of bacteria on chocolate agar post-antibiotic administration, t=1 hr
Primary	Evidence of growth and number of colonies of bacteria on blood agar post-antibiotic administration, t=1 hr