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”

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.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: 0.5% levofloxacin eye drops
  • 0.5% levofloxacin eye drops three times daily to each eye for 5 days
• 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)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Group A
  • Experimental dosage
• Active Comparator: Group B
  • Classical dosage

Primary Measures

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

Secondary Measures

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

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 Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 70 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Laser Microsurgery Centre, Poland

Overall Clinical Trial Officials and Contacts

Jerzy Szaflik, MD,Ph.D. Principal Investigator Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00565123

Study ID Number: LF- 12/2003

ClinicalTrials.gov Identifier: NCT00565123

Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products