Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
- Registration Number
- NCT00565123
- Lead Sponsor
- Laser Microsurgery Centre, Poland
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group A 0.5% levofloxacin eye drops Experimental dosage Group B 0.5% levofloxacin eye drops Classical dosage
- Primary Outcome Measures
Name Time Method The primary efficacy endpoint was the clinical cure. 7(+-1) days
- Secondary Outcome Measures
Name Time Method The secondary efficacy end point was the microbiological eradication. 7(+-1) days
Trial Locations
- Locations (1)
Centrum Mikrochirurgii Oka Laser
🇵🇱Warszawa, Mazowieckie, Poland