Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
Information source: Laser Microsurgery Centre, Poland
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bacterial Conjunctivitis
Intervention: 0.5% levofloxacin eye drops (Drug); 0.5% levofloxacin eye drops (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Laser Microsurgery Centre, Poland Official(s) and/or principal investigator(s):
Jerzy Szaflik, MD,Ph.D., Principal Investigator, Affiliation: Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw
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.
Clinical Details
Official title: 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
Study design: Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary efficacy endpoint was the clinical cure.
Secondary outcome: The secondary efficacy end point was the microbiological eradication.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
Centrum Mikrochirurgii Oka Laser, Warszawa, Mazowieckie 00-131, Poland
Additional Information
Starting date: September 2004
Ending date: January 2006
Last updated: November 28, 2007
|
