Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis

This study has been completed.

First Received: November 27, 2007 Last Updated: November 28, 2007 History of Changes

Sponsors and Collaborators:	Laser Microsurgery Centre, Poland Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie, Samodzielny Publiczny Kliniczny Szpital Okulistyczny w Warszawie MedSource Polska Sp. z o.o.
Information provided by:	Laser Microsurgery Centre, Poland
ClinicalTrials.gov Identifier:	NCT00565123

Purpose

The aim of the study is to evaluate the clinical and microbiological efficacies of three times daily administration of levofloxacin 0,5% eye drops as compared to the more frequent dosing (up to 8 times a day during the first 2 days and up to 4 times a day during the next 3 days) in patients with bacterial conjunctivitis.

Condition	Intervention	Phase
Bacterial Conjunctivitis	Drug: 0.5% levofloxacin eye drops	Phase II Phase III

MedlinePlus related topics: Pinkeye

Drug Information available for: Ofloxacin Tetrahydrozoline Levofloxacin Ofloxacin hydrochloride Tetrahydrozoline hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Single- Centre, Randomised Study Of The Clinical And Microbiological Efficacy Of Decreasing The Dosage Of Levofloxacin 0,5% Eye Drops As Compared To Standard Eye Drop Dosage In Patients With Bacterial Conjunctivitis

Further study details as provided by Laser Microsurgery Centre, Poland:

Primary Outcome Measures:

The primary efficacy endpoint was the clinical cure. [ Time Frame: 7(+-1) days ]

Secondary Outcome Measures:

The secondary efficacy end point was the microbiological eradication. [ Time Frame: 7(+-1) days ]

Enrollment:	119
Study Start Date:	September 2004
Study Completion Date:	January 2006

Arms	Assigned Interventions
Group A: Experimental Experimental dosage	Drug: 0.5% levofloxacin eye drops 0.5% levofloxacin eye drops three times daily to each eye for 5 days
Group B: Active Comparator Classical dosage	Drug: 0.5% levofloxacin eye drops 0.5% levofloxacin eye drops 2 hours on days 1 and 2, and then every 4 hours on days 3-5 (up to 4 times per day)

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female patients between 18 and 70 years of age
Patients with Conjunctivitis (defined as the presence of three cardinal signs: conjunctival discharge, bulbar conjunctival injection and palpebral conjunctival injection)
Patients who have given and signed informed consent
The ability and willingness to comply with all study procedures

Exclusion Criteria:

Insulin Dependent Diabetes Mellitus (IDDM)
Patients with keratitis or hordeolum
Glaucoma
Sjogren's Syndrom and "Sick Eye's Syndrom".
Ectropion, entropion;
Using contact lenses during the study
Poor visual acuity in the other eye
Prior and concurrent concomitant treatment glycocorticosteroids, immunosupressive therapy, if these treatments have not stopped at least 3 months prior to the start of the study;
Concurrent use of non- steriodal anti- inflammatory drugs (NSAIDs), with the exception of low- dose aspirin. (see par. 11.5)
Prior and concurrent systemic antibiotic treatment during last 7 days before the beginning the study.(see par. 11.5)
Concurrent other eye drops
All ocular surgeries which were performed less than 6 months before the beginning of the study.
Any clinical condition, which, in the opinion of the investigator would not allow safe completion of the protocol.
History of any malignancy within the past 5 years prior to study entry, except basal cell or squamous cell skin carcinoma.
Hypersensitivity to fluoroquinolons and benzalkonium chloride;
Intended or ascertained pregnancy or lactation;
Participation in a clinical trial within last 30 days.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565123

Locations

Poland, Mazowieckie
Centrum Mikrochirurgii Oka Laser
Warszawa, Mazowieckie, Poland, 00-131

Sponsors and Collaborators

Laser Microsurgery Centre, Poland

Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,

Samodzielny Publiczny Kliniczny Szpital Okulistyczny w Warszawie

MedSource Polska Sp. z o.o.

Investigators

Principal Investigator:

Jerzy Szaflik, MD,Ph.D.

Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw

More Information

No publications provided

Study ID Numbers:	LF- 12/2003
Study First Received:	November 27, 2007
Last Updated:	November 28, 2007
ClinicalTrials.gov Identifier:	NCT00565123 History of Changes
Health Authority:	Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by Laser Microsurgery Centre, Poland:

bacterial conjunctivitis levofloxacin fluoroquinolone

Study placed in the following topic categories:

Pseudoephedrine
Bacterial Infections
Eye Infections, Bacterial
Conjunctivitis, Bacterial
Fluoroquinolones
Eye Diseases
Eye Infections
Ofloxacin
Anti-Infective Agents, Urinary
Cardiovascular Agents

Conjunctivitis
Tetrahydrozoline
Conjunctival Diseases
Nasal Decongestants
Anti-Bacterial Agents
Oxymetazoline
Phenylephrine
Vasoconstrictor Agents
Ephedrine
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Bacterial Infections
Respiratory System Agents
Anti-Infective Agents
Conjunctivitis, Bacterial
Molecular Mechanisms of Pharmacological Action
Ofloxacin
Physiological Effects of Drugs
Tetrahydrozoline
Renal Agents
Infection
Nasal Decongestants
Anti-Bacterial Agents
Therapeutic Uses
Vasoconstrictor Agents

Nucleic Acid Synthesis Inhibitors
Eye Infections, Bacterial
Sympathomimetics
Eye Diseases
Eye Infections
Anti-Infective Agents, Urinary
Enzyme Inhibitors
Conjunctivitis
Cardiovascular Agents
Conjunctival Diseases
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009