Clinical trial NCT00565123: Study of Efficacy of Levofloxacin 0.5% Ophthalmic Solution Administered Three Times a Day for Bacterial Conjunctivitis
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Bacterial Conjunctivitis
Keywords: bacterial conjunctivitis levofloxacin fluoroquinolone
Lead sponsor: Laser Microsurgery Centre, Poland
Sponsor class: OTHER
Collaborators: name: Katedra I Klinika Okulistyki II Wydz. Lek. AM w Warszawie,
name: University Hospital No 1 Wroclaw
name: MedSource Polska
First posted: 2007-11-29
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The primary efficacy endpoint was the clinical cure.
timeFrame: 7(+-1) days
Secondary outcomes:
measure: The secondary efficacy end point was the microbiological eradication.
timeFrame: 7(+-1) days
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: Centrum Mikrochirurgii Oka Laser
state: Mazowieckie
Study officials:
affiliation: Laser Microsurgery Centre; Department of Ophthalmology, Medical University of Warsaw
name: Jerzy Szaflik, MD,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: