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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2006 by Ophthalmic Consultants of Boston.
Recruitment status was:  Active, not recruiting
Information provided by:
Ophthalmic Consultants of Boston Identifier:
First received: June 30, 2006
Last updated: July 3, 2006
Last verified: June 2006
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.

Condition Intervention Phase
Eye Infection
Drug: Moxifloxacin ophthalmic solution 0.5%
Drug: Gatifloxacin ophthalmic solution 0.3%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by Ophthalmic Consultants of Boston:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 40
Study Start Date: June 2006
Estimated Study Completion Date: June 2006
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.


Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
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Please refer to this study by its identifier: NCT00347828

United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Ophthalmic Consultants of Boston
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
  More Information Identifier: NCT00347828     History of Changes
Other Study ID Numbers: Allergan/Z101
Study First Received: June 30, 2006
Last Updated: July 3, 2006

Keywords provided by Ophthalmic Consultants of Boston:
Antibiotic prophylaxis
Preoperative antibiotic
Eye infection

Additional relevant MeSH terms:
Communicable Diseases
Eye Infections
Eye Diseases
Pharmaceutical Solutions
Anti-Bacterial Agents
Antibiotics, Antitubercular
Norgestimate, ethinyl estradiol drug combination
Ophthalmic Solutions
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors processed this record on April 25, 2017