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

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ClinicalTrials.gov Identifier: NCT00491049
Recruitment Status : Completed
First Posted : June 25, 2007
Last Update Posted : June 25, 2007
Sponsor:
Collaborator:
Santen Gmbh
Information provided by:
Ludwig-Maximilians - University of Munich

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Conjunctival Bacterial Flora Drug: 0.5% levofloxacin eye drops Phase 4

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : September 2004
Actual Study Completion Date : April 2005

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00491049


Locations
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Germany
Augenklinik der LMU
Munich, Bavaria, Germany, 80336
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Santen Gmbh
Investigators
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Principal Investigator: Herminia Mino de Kapsar, PhD Augenklinik der LMU
More Information
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Additional Information:
Website of the university eye hospital at the Ludwig-Maximilians University in Munich  This link exits the ClinicalTrials.gov site

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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ClinicalTrials.gov Identifier: NCT00491049     History of Changes
Other Study ID Numbers: LevoProMUC03
First Posted: June 25, 2007    Key Record Dates
Last Update Posted: June 25, 2007
Last Verified: June 2007
Keywords provided by Ludwig-Maximilians - University of Munich:
prophylaxis
intraocular surgery
endophthalmitis
antibiotic
Additional relevant MeSH terms:
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Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
 Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors