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

This study has been completed.

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

Sponsor:	Laser Microsurgery Centre, Poland
Collaborators:	Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie, University Hospital No 1 Wroclaw 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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Pinkeye

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

U.S. FDA Resources

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
Experimental: Group A Experimental dosage	Drug: 0.5% levofloxacin eye drops 0.5% levofloxacin eye drops three times daily to each eye for 5 days
Active Comparator: Group B 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
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,

University Hospital No 1 Wroclaw

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

ClinicalTrials.gov Identifier:	NCT00565123 History of Changes
Other Study ID Numbers:	LF- 12/2003
Study First Received:	November 27, 2007
Last Updated:	November 28, 2007
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

Additional relevant MeSH terms:

Conjunctivitis
Conjunctivitis, Bacterial
Conjunctival Diseases
Eye Diseases
Eye Infections, Bacterial
Bacterial Infections
Eye Infections
Infection
Tetrahydrozoline
Ofloxacin
Nasal Decongestants
Vasoconstrictor Agents
Cardiovascular Agents
Therapeutic Uses

Pharmacologic Actions
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents

ClinicalTrials.gov processed this record on February 09, 2012