Effectiveness of Topical 0.5% Levofloxacin to Reduce the Conjunctival Bacterial Flora Before Intraocular Surgery

This study has been completed.
Sponsor:
Collaborator:
Santen Gmbh
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT00491049
First received: June 21, 2007
Last updated: NA
Last verified: June 2007
History: No changes posted
  Purpose

The purpose of this study is to determine whether additional topical application of 0.5% levofloxacin is more effective in reducing the load of the conjunctival bacterial flora in patients scheduled for intraocular surgery than preoperative irrigation of the conjunctiva with povidone iodine alone.


Condition Intervention Phase
Conjunctival Bacterial Flora
Drug: 0.5% levofloxacin eye drops
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Phase 4 Study on Effectiveness of Topical 0.5% Levofloxacin on Reduction of Preoperative Conjunctival Flora in Patients Scheduled for Intraocular Surgery

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Rate of culture positive results in thioglycolate broth from conjunctival swabs at defined time points [ Time Frame: maximum 7 days before surgery until conclusion of surgery ]

Secondary Outcome Measures:
  • Numbers of colony forming units (CFUs) found on solid media. Specimens were cultured aerobically and micro-aerobically on blood agar plates and anaerobically on chocolate agar plates and CFUs were determined on each plate using a magnifying glass. [ Time Frame: maximum 7 days before surgery until concluison of surgery ]

Enrollment: 140
Study Start Date: September 2004
Study Completion Date: April 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing surgery for cataract, glaucoma or vitrectomy

Exclusion Criteria:

  • Patients who report to be allergic to levofloxacin or iodine
  • Patients on topical antibiotic within the last 30 days
  • Patients with acute conjunctivitis, blepharitis or dacryocystitis
  • Patients under age of 18 years
  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: NCT00491049

Locations
Germany
Augenklinik der LMU
Munich, Bavaria, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Santen Gmbh
Investigators
Principal Investigator: Herminia Mino de Kapsar, PhD Augenklinik der LMU
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00491049     History of Changes
Other Study ID Numbers: LevoProMUC03
Study First Received: June 21, 2007
Last Updated: June 21, 2007
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Ludwig-Maximilians - University of Munich:
prophylaxis
intraocular surgery
endophthalmitis
antibiotic

Additional relevant MeSH terms:
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on October 01, 2014