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

Tracking Information

First Received Date ^ICMJE

November 27, 2007

Last Updated Date

November 28, 2007

Start Date ^ICMJE

September 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00565123 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Bacterial Conjunctivitis

Intervention ^ICMJE

Drug: 0.5% levofloxacin eye drops

Study Arms / Comparison Groups

Experimental: Experimental dosage
Active Comparator: Classical dosage

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

119

Completion Date

January 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Poland

Administrative Information

NCT ID ^ICMJE

NCT00565123

Responsible Party

Study ID Numbers ^ICMJE

LF- 12/2003

Study Sponsor ^ICMJE

Laser Microsurgery Centre, Poland

Collaborators ^ICMJE

Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,
Samodzielny Publiczny Kliniczny Szpital Okulistyczny w Warszawie
MedSource Polska Sp. z o.o.

Investigators ^ICMJE

Principal Investigator:

Jerzy Szaflik, MD,Ph.D.

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

Information Provided By

Laser Microsurgery Centre, Poland

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP