Trial | NCT00565123  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    levofloxacin ...

  • Study Participants

    119
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 Started
Sep 30
2004
Study Completion
Jan 31
2006
Last Update
Nov 29
2007
Estimate

Drug 0.5% levofloxacin eye drops

0.5% levofloxacin eye drops three times daily to each eye for 5 days

Drug 0.5% levofloxacin eye drops

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)

Group A Experimental

Experimental dosage

Group B Active Comparator

Classical dosage

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.
No Results Posted