Effectiveness of Topical 0.5% Levofloxacin to Reduce the Conjunctival Bacterial Flora Before Intraocular Surgery - Full Text View

Sponsor:	Ludwig-Maximilians - University of Munich
Collaborator:	Santen Gmbh
Information provided by:	Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:	NCT00491049

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:

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

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

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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

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:

Website of the university eye hospital at the Ludwig-Maximilians University in Munich This link exits the ClinicalTrials.gov site

Publications:

Speaker MG, Milch FA, Shah MK, Eisner W, Kreiswirth BN. Role of external bacterial flora in the pathogenesis of acute postoperative endophthalmitis. Ophthalmology. 1991 May;98(5):639-49; discussion 650.

Bannerman TL, Rhoden DL, McAllister SK, Miller JM, Wilson LA. The source of coagulase-negative staphylococci in the Endophthalmitis Vitrectomy Study. A comparison of eyelid and intraocular isolates using pulsed-field gel electrophoresis. Arch Ophthalmol. 1997 Mar;115(3):357-61.

Ta CN, Egbert PR, Singh K, Shriver EM, Blumenkranz MS, Mino De Kaspar H. Prospective randomized comparison of 3-day versus 1-hour preoperative ofloxacin prophylaxis for cataract surgery. Ophthalmology. 2002 Nov;109(11):2036-40; discussion 2040-1.

De Kaspar HM, Chang RT, Shriver EM, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Three-day application of topical ofloxacin reduces the contamination rate of microsurgical knives in cataract surgery: a prospective randomized study. Ophthalmology. 2004 Jul;111(7):1352-5.

Mino de Kaspar H, Chang RT, Singh K, Egbert PR, Blumenkranz MS, Ta CN. Prospective randomized comparison of 2 different methods of 5% povidone-iodine applications for anterior segment intraocular surgery. Arch Ophthalmol. 2005 Feb;123(2):161-5.

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

Miño de Kaspar H, Kreutzer TC, Aguirre-Romo I, Ta CN, Dudichum J, Bayrhof M, Klauss V, Kampik A. A prospective randomized study to determine the efficacy of preoperative topical levofloxacin in reducing conjunctival bacterial flora. Am J Ophthalmol. 2008 Jan;145(1):136-142. Epub 2007 Nov 8.

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:

Ofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on May 24, 2012