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

Laser Microsurgery Centre, Poland

Status and phase

Completed

Phase 3

Phase 2

Conditions

Bacterial Conjunctivitis

Treatments

Drug: 0.5% levofloxacin eye drops

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00565123

LF- 12/2003

Details and patient eligibility

About

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.

Enrollment

119 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.