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

Condition(s) targeted: Eye Infection; Infection

Intervention: Moxifloxacin ophthalmic solution 0.5% (Drug); Gatifloxacin ophthalmic solution 0.3% (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Ophthalmic Consultants of Boston

Official(s) and/or principal investigator(s):
Michael B Raizman, B.A./M.D., Principal Investigator, Affiliation: Ophthalmic Consultants of Boston
Sandra Y Cho, B.A./M.D., Study Director, Affiliation: New England Eye Center/Tufts-New England Medical Center
Rahul Mandiga, B.S., Study Director, Affiliation: New England Eye Center/Tufts-New England Medical Center

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.

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

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

Primary outcome:

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

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.

Minimum age: 25 Years. Maximum age: N/A. Gender(s): Both.

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

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

Starting date: June 2006
Last updated: July 3, 2006