- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00565123
Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
November 28, 2007 updated by: Laser Microsurgery Centre, Poland
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
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
119
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mazowieckie
-
Warszawa, Mazowieckie, Poland, 00-131
- Centrum Mikrochirurgii Oka Laser
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group A
Experimental dosage
|
0.5% levofloxacin eye drops three times daily to each eye for 5 days
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
|
0.5% levofloxacin eye drops three times daily to each eye for 5 days
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.
Time Frame: 7(+-1) days
|
7(+-1) days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The secondary efficacy end point was the microbiological eradication.
Time Frame: 7(+-1) days
|
7(+-1) days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jerzy Szaflik, MD,Ph.D., Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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