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

• 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)

• Experimental: Group A
  Experimental dosage
  Intervention: Drug: 0.5% levofloxacin eye drops
• Active Comparator: Group B
  Classical dosage
  Intervention: Drug: 0.5% levofloxacin eye drops

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.

• Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,
• University Hospital No 1 Wroclaw
• MedSource Polska Sp. z o.o.