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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bacterial Conjunctivitis

Intervention / Treatment
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* Drug: 0.5% levofloxacin eye drops
* Drug: 0.5% levofloxacin eye drops


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Experimental dosage | Drug: 0.5% levofloxacin eye drops<br>* 0.5% levofloxacin eye drops three times daily to each eye for 5 days<br>|
| Active Comparator: Group B<br>Classical dosage | Drug: 0.5% levofloxacin eye drops<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bacterial conjunctivitis levofloxacin fluoroquinolone