Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2006 by Ophthalmic Consultants of Boston.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Allergan
Information provided by:
Ophthalmic Consultants of Boston
ClinicalTrials.gov Identifier:
NCT00347828
First received: June 30, 2006
Last updated: July 3, 2006
Last verified: June 2006
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00347828

Locations
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Ophthalmic Consultants of Boston
Allergan
Investigators
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

No publications provided

ClinicalTrials.gov Identifier: NCT00347828     History of Changes
Other Study ID Numbers: Allergan/Z101
Study First Received: June 30, 2006
Last Updated: July 3, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Ophthalmic Consultants of Boston:
Antibiotic prophylaxis
Vigamox
Moxifloxacin
Zymar
Gatifloxacin
Preoperative antibiotic
Eye infection

Additional relevant MeSH terms:
Communicable Diseases
Eye Infections
Infection
Eye Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Disinfectants
Fluoroquinolones
Gatifloxacin
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Ophthalmic Solutions
Pharmaceutical Solutions
Anti-Infective Agents
Antineoplastic Agents
Antitubercular Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014