Effectiveness Study of Zymar Versus Vigamox for Preoperative Sterilization of the Ocular Surface After Loading Dose
Recruitment status was Active, not recruiting
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.
Drug: Moxifloxacin ophthalmic solution 0.5%
Drug: Gatifloxacin ophthalmic solution 0.3%
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Prevention
|Official Title:||Prospective Study Comparing the Effectiveness of Zymar and Vigamox for Preoperative Antibiotic Sterilization of the Ocular Surface After Loading Dose|
- 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
|Study Start Date:||June 2006|
|Estimated Study Completion Date:||June 2006|
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.
|United States, Massachusetts|
|Ophthalmic Consultants of Boston|
|Boston, Massachusetts, United States, 02114|
|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|