Clinical trial NCT00347828: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Eye Infection
Infection
Keywords: Antibiotic prophylaxis
Vigamox
Moxifloxacin
Zymar
Gatifloxacin
Preoperative antibiotic
Eye infection
Lead sponsor: Ophthalmic Consultants of Boston
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2006-07-04
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Evidence of growth and number of colonies of bacteria on chocolate agar prior to antibiotic administration, t=0 hrs
measure: Evidence of growth and number of colonies of bacteria on blood agar prior to antibiotic administration, t=0 hrs
measure: Evidence of growth and number of colonies of bacteria on chocolate agar post-antibiotic administration, t=1 hr
measure: Evidence of growth and number of colonies of bacteria on blood agar post-antibiotic administration, t=1 hr
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
Study officials:
affiliation: Ophthalmic Consultants of Boston
name: Michael B Raizman, B.A./M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: New England Eye Center/Tufts-New England Medical Center
name: Sandra Y Cho, B.A./M.D.
role: STUDY_DIRECTOR
affiliation: New England Eye Center/Tufts-New England Medical Center
name: Rahul Mandiga, B.S.
role: STUDY_DIRECTOR
References: