Overview

This trial is active, not recruiting.

Conditions eye infection, infection
Treatments moxifloxacin ophthalmic solution 0.5%, gatifloxacin ophthalmic solution 0.3%
Phase phase 4
Sponsor Ophthalmic Consultants of Boston
Collaborator Allergan
Start date June 2006
End date June 2006
Trial size 40 participants
Trial identifier NCT00347828, Allergan/Z101

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking double-blind
Primary purpose prevention

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 25 years old.

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

Additional Information

Official title Prospective Study Comparing the Effectiveness of Zymar and Vigamox for Preoperative Antibiotic Sterilization of the Ocular Surface After Loading Dose
Principal investigator Michael B Raizman, B.A./M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2006.
Information provided to ClinicalTrials.gov by Ophthalmic Consultants of Boston.