Ofloxacin Ophthalmic (Ofloxacin Ophthalmic) - Summary

SUMMARY

Ofloxacin Ophthalmic Solution
USP, 0.3%
Sterile

Ofloxacin Ophthalmic Solution USP, 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use. Chemical Name: (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1- piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4 benzoxazine-6-carboxylic acid.

Ofloxacin Ophthalmic Solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:

CONJUNCTIVITIS

Gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae

Gram-negative bacteria:
Enterobacter cloacae
Haemophilus influenzae
Proteus mirabilis
Pseudomonas aeruginosa

CORNEAL ULCERS

Gram-positive bacteria:
Staphylococcus aureus
Staphylococcus epidermidis
Streptococcus pneumoniae

Gram-negative bacteria:
Pseudomonas aeruginosa
Serratia marcescens*

Anaerobic species:
Propionibacterium acnes

*Efficacy for this organism was studied in fewer than 10 infections.

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NEWS HIGHLIGHTS

Published Studies Related to Ofloxacin Ophthalmic

A prospective study determining the efficacy of topical 0.5% levofloxacin on bacterial flora of patients with chronic blepharoconjunctivitis. [2009.07]
BACKGROUND: To determine the efficacy of conjunctival bacterial eradication following a 1-day, 3-day and 7-day application of topical 0.5% levofloxacin, with and without eyelid scrub, in patients with chronic blepharoconjunctivitis (CBC)... CONCLUSIONS: CBC eyes have a significantly higher number of positive cultures than eyes without CBC. The application of topical 0.5% levofloxacin for at least 3 days provided a significant reduction in the number of positive cultures as well as the number of bacteria harbored on the conjunctival surface.

Increased anterior chamber penetration of topical levofloxacin 0.5% after pulsed dosing in cataract patients. [2009.03]
PURPOSE: This study aimed to investigate the rise in aqueous humour (AH) levels of levofloxacin after a specific perioperative pulsed topical drop regimen... CONCLUSIONS: This is the first study to measure AH levels of levofloxacin after postoperative pulsed dosing in humans. Higher AH levels were found than in previously reported studies in which only preoperative drops were given and levels were measured at the time of surgery. Levels of levofloxacin continued to rise for 60 mins after administration of the last postoperative drop, demonstrating that delivery and maintenance of effective antibiotic levels may be achievable with alternative dosing schedules.

Clinical and microbiological efficacy of levofloxacin administered three times a day for the treatment of bacterial conjunctivitis. [2009.01]
PURPOSE: This randomized, investigator-masked study aimed to compare the clinical and microbiological effectiveness of three times daily administration of levofloxacin 0.5% eyedrops with the classic, more frequent dosing in patients with bacterial conjunctivitis... CONCLUSIONS: There was no statistically significant difference in the efficacy or safety between the two methods of drug administration. Analysis of the results of compliance supported our conclusion that the less frequent method of dosing of 0.5% levofloxacin eyedrops was more convenient for patients and resulted in better adherence to the drug-dosing scheme.

Ciprofloxacin or metronidazole for the treatment of perianal fistulas in patients with Crohn's disease: A randomized, double-blind, placebo-controlled pilot study. [2008.07.30]
Background: Although metronidazole and ciprofloxacin are used to treat perianal Crohn's disease (CD), no placebo-controlled trials have been performed.Methods: We performed a placebo-controlled pilot trial to evaluate the efficacy and safety of metronidazole and ciprofloxacin in patients with perianal CD...

Ocular penetration of levofloxacin, ofloxacin and ciprofloxacin in eyes with functioning filtering blebs: investigator masked, randomised clinical trial. [2008.03]
BACKGROUND/AIMS: To compare the penetration of levofloxacin, ofloxacin and ciprofloxacin in the aqueous humour of eyes with functioning filtering blebs... CONCLUSIONS: Topical levofloxacin penetrates better than ofloxacin or ciprofloxacin into the aqueous of eyes with functioning filtering blebs. The combination of topical and oral levofloxacin may be preferable in the treatment of bleb-associated infections (NCT 00392275; Clinical trials.gov).

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Clinical Trials Related to Ofloxacin Ophthalmic

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers [Completed]
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

MSI-78 Topical Cream vs. Oral Ofloxacin in the Treatment of Infected Diabetic Ulcers [Completed]
224 adults with diabetic foot ulcers will be randomized to either magainin peptide (MSI-78) or ofloxacin (FLOXIN, Ortho-McNeil Pharmaceutical Corporation) an oral fluoroquinolone antibiotic.

An Effectiveness and Safety Study for Levofloxacin in Chronic Prostatitis [Active, not recruiting]
The purpose of this study is to compare the safety and effectiveness of levofloxacin 750 mg for 2 weeks or 750 mg for 3 weeks, compared to levofloxacin 500 mg for 4 weeks in the treatment of chronic prostatitis.

A Study to Evaluate the Bioequivalence of an Oral Suspension Formulation, an Oral Solution Formulation, and the Marketed Tablet Formulation of Levofloxacin in Healthy Subjects [Completed]
The primary objective of the study was to assess the bioequivalence of the oral suspension formulation, the oral solution formulation, and the marketed tablet formulation of levofloxacin, with the marketed tablet as the reference.

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

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