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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laser Microsurgery Centre, Poland
• Collaborators: Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,; MedSource Polska; University Hospital No 1 Wroclaw
• Treatments: Levofloxacin; Ofloxacin; Ophthalmic Solutions; Tetrahydrozoline

Criteria

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.