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

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 Overview

• Status: Completed
• Conditions: Bacterial Conjunctivitis
• Intervention / Treatment: Drug: 0.5% levofloxacin eye drops; Drug: 0.5% levofloxacin eye drops

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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)
Active Comparator: Group B; Classical dosage	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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Laser Microsurgery Centre, Poland
• Collaborators: Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,; University Hospital No 1 Wroclaw; MedSource Polska
• Investigators: Principal Investigator: Jerzy Szaflik, MD,Ph.D., Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start: September 1, 2004
• Study Completion (Actual): January 1, 2006

Study Registration Dates

• First Submitted: November 27, 2007
• First Submitted That Met QC Criteria: November 28, 2007
• First Posted (Estimate): November 29, 2007

Study Record Updates

• Last Update Posted (Estimate): November 29, 2007
• Last Update Submitted That Met QC Criteria: November 28, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: bacterial conjunctivitis levofloxacin fluoroquinolone
• Additional Relevant MeSH Terms: Infections; Eye Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Conjunctival Diseases; Eye Infections, Bacterial; Eye Infections; Conjunctivitis; Conjunctivitis, Bacterial; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Pharmaceutical Solutions; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Ophthalmic Solutions; Levofloxacin; Ofloxacin
• Other Study ID Numbers: LF- 12/2003