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

Aqueous and vitreous penetration of linezolid and levofloxacin after oral administration. [2010.12]
PURPOSE: To evaluate the time course of drug concentrations achieved in aqueous (AQ), vitreous (V), and serum (S) compartments after oral administration of linezolid and levofloxacin. DESIGN: Randomized, clinical trial... CONCLUSIONS: Single concomitant doses of linezolid and levofloxacin achieved AQ and V concentrations above the minimum inhibitory concentration for 90% of common ocular gram-positive and gram-negative pathogens up to 12 h after administration. The combination of linezolid and levofloxacin represents a viable option for the prophylaxis and management of endophthalmitis.

Short-term comparative study of the effects of preserved and unpreserved topical levofloxacin on the human ocular surface. [2010.12]
PURPOSE: To compare the short-term effects of preserved and unpreserved topical levofloxacin on the ocular surface of preoperative patients with age-related cataracts... CONCLUSION: Regarding the short-term effects on the ocular surface of patients with age-related cataracts, no clinically and statistically significant differences were observed between topical levofloxacin preserved with BOB and its unpreserved counterpart.

Tear concentration and safety of levofloxacin ophthalmic solution 1.5% compared with ofloxacin ophthalmic solution 0.3% after topical administration in healthy adult volunteers. [2010.03]
PURPOSE: This study evaluated the tear concentration and safety of levofloxacin ophthalmic solution 1.5%... CONCLUSION: A single dose of levofloxacin 1.5% produced tear fluid concentrations that were well above the minimum inhibitory concentration90 for typical ocular pathogens and was safe and well tolerated.

[Human aqueous humor levels of levofloxacin 0.5%, gatifloxacin 0.3% and levofloxacin 0.3% ophthalmic solution after topical dosing.] [2009.11]
OBJECTIVE: To compare the aqueous humor concentration of levofloxacin 0.5%, gatifloxacin 0.3% and levofloxacin 0.3% ophthalmic solution after topical dosing in human eyes... CONCLUSION: Topically applied levofloxacin 0.5% had the higher aqueous humor drug level than gatifloxacin 0.3% and levofloxacin 0.3%.

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.

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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.

"Efficacy and Safety of Levofloxacin vs Isoniazid in Latent Tuberculosis Infection in Liver Transplant Patients". [Recruiting]
A multicenter, prospective, non-inferiority, randomized and open clinical trial comparing levofloxacin with isoniazid in the treatment of latent tuberculosis infection in patients eligible for liver transplantation.

Patients over 18 years of age on the waiting list for liver transplantation.

Sample size: n=870 patients.

HYPOTHESIS

Levofloxacin treatment of latent tuberculosis infection, begun while on the waiting list for liver transplantation, is safer and not less effective than isoniazid treatment begun after transplantation when liver function is stable.

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.

Comparison of the Effect Between Levofloxacin and Moxifloxacin Among MDR-TB Patients [Recruiting]
Fluoroquinolone is a one of the most important drugs for treatment of multidrug-resistant TB (MDR-TB). Among them, levofloxacin and moxifloxacin has been used most widely. However, there is no study to directly compare the efficacy of levofloxacin and moxifloxacin among MDR-TB patients. The investigators will compare the efficacy of levofloxacin and moxifloxacin through a prospective multicenter randomized open label phase III trial.

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