Tobrex (Tobramycin Ophthalmic) - Summary

TOBREX SUMMARY

Tobrex®
(tobramycin ophthalmic solution) 0.3%

TOBREX® (tobramycin ophthalmic solution) 0.3% is a sterile topical ophthalmic antibiotic formulation prepared specifically for topical therapy of external ophthalmic infections. Each mL of TOBREX solution contains: Active: tobramycin 0.3% (3 mg). Preservative: benzalkonium chloride 0.01% (0.1 mg). Inactives: boric acid, sodium sulfate, sodium chloride, tyloxapol, sodium hydroxide and/or sulfuric acid (to adjust pH) and purified water. TOBREX (tobramycin ophthalmic solution) 0.3% has a pH range between 7.0 and 8.0. Tobramycin is a water-soluble aminoglycoside antibiotic active against a wide variety of gram-negative and gram-positive ophthalmic pathogens.

TOBREX (tobramycin ophthalmic solution) 0.3% is a topical antibiotic indicated in the treatment of external infections of the eye and its adnexa caused by susceptible bacteria. Appropriate monitoring of bacterial response to topical antibiotic therapy should accompany the use of TOBREX. Clinical studies have shown tobramycin to be safe and effective for use in children.

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NEWS HIGHLIGHTS

Published Studies Related to Tobrex (Tobramycin Ophthalmic)

Effects of loteprednol/tobramycin versus dexamethasone/tobramycin on intraocular pressure in healthy volunteers. [2008.01]
PURPOSE: To compare the steroid-induced intraocular pressure (IOP) and other ocular adverse effects of loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension with those of dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension... CONCLUSIONS: Loteprednol/tobramycin was significantly less likely to produce elevations in IOP than was dexamethasone/tobramycin in healthy subjects treated for 28 days. Both loteprednol etabonate/tobramycin and dexamethasone/tobramycin were well tolerated with low risks for systemic AEs and ocular AEs other than elevation in IOP for dexamethasone/tobramycin.

Comparison of the safety and efficacy of loteprednol 0.5%/tobramycin 0.3% with dexamethasone 0.1%/tobramycin 0.3% in the treatment of blepharokeratoconjunctivitis. [2008.01]
CONCLUSIONS: LE/T satisfied the condition of non-inferiority to DM/T in decreasing the signs and symptoms of ocular inflammation associated with blepharokeratoconjunctivitis. Subjects treated with DM/T experienced more of an increase in IOP. Limitation: Although the single-masked design of this study could be considered a limitation, care was taken to ensure that the investigator was masked.

Phase 3 Safety Comparisons for 1.0% Azithromycin in Polymeric Mucoadhesive Eye Drops versus 0.3% Tobramycin Eye Drops for Bacterial Conjunctivitis. [2007.08]
PURPOSE: To compare the safety and tolerability of 1.0% azithromycin in a polymeric mucoadhesive delivery system with 0.3% tobramycin ophthalmic solution for the treatment of bacterial conjunctivitis... CONCLUSIONS: This is the first report of the safety and tolerability of a commercially manufactured preparation of azithromycin for ophthalmic use. Azithromycin 1% in DuraSite is safe and can be administered in a regimen of less frequent doses than can tobramycin, while producing an equivalent clinical outcome. The formulation is well tolerated in patients over the age of 1 year for the eradication of bacteria commonly associated with conjunctivitis. (ClinicalTrials.gov number, NCT00105469.).

A randomized trial assessing the clinical efficacy and microbial eradication of 1% azithromycin ophthalmic solution vs tobramycin in adult and pediatric subjects with bacterial conjunctivitis. [2007.06]
OBJECTIVE: The study was designed to evaluate the efficacy of an ophthalmic formulation of 1% azithromycin in DuraSite((R)) (AzaSite, InSite Vision, Alameda CA, USA) and demonstrate equivalence with 0.3% tobramycin ophthalmic solution, USP, for the treatment of bacterial conjunctivitis as defined by the resolution of clinical signs and the eradication of pathogens. DESIGN: Prospective, randomized, active-controlled, double-masked, phase 3 trial conducted at 47 US sites between 6 August 2004 and 6 October 2005. PARTICIPANTS: Subjects aged 1 year or older with diagnosis of acute bacterial conjunctivitis... CONCLUSIONS: The efficacy of 1% azithromycin in DuraSite and tobramycin are equivalent; however, this formulation of azithromycin also permits effective dosing intervals of twice a day on days 1 and 2 followed by once daily on the last 3 days of therapy, for a total of 65% fewer doses. In vitro, the killing spectrum of 1% azithromycin in DuraSite appears to be enhanced relative to 1% azithromycin without DuraSite.

3-day treatment with azithromycin 1.5% eye drops versus 7-day treatment with tobramycin 0.3% for purulent bacterial conjunctivitis: multicentre, randomised and controlled trial in adults and children. [2007.04]
AIM: To compare the efficacy and safety of Azyter, azithromycin 1.5% eye drops, for 3 days with tobramycin 0.3% for 7 days to treat purulent bacterial conjunctivitis... CONCLUSIONS: Azithromycin 1.5% for 3 days was as effective and as safe as tobramycin for 7 days. Furthermore, more azithromycin than tobramycin patients presented an early clinical cure at Day 3. Due to its twice daily dosing regimen for 3 days, azithromycin represents a step forward in the management of purulent bacterial conjunctivitis, especially in children.

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Clinical Trials Related to Tobrex (Tobramycin Ophthalmic)

Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study [Completed]
This study assesses the aerosol delivery characteristics (measured by in vivo lung deposition, nebulization time, serum tobramycin concentrations, and pharmacokinetic parameters) and safety of tobramycin inhalation solution administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in healthy subjects and in subjects with cystic fibrosis.

Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study [Completed]
This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic nebulizer (no compressor) vs. PARI LC PLUS Jet Nebulizer (with compressor) in subjects with cystic fibrosis.

The Tobramycin Study [Completed]
Evaluate if tobramycin given once a day is at least as efficacious as the traditional tobramycin given three times a day, given with penicillin G, til patients with febrile neutropenia.

Efficacy and Safety of 28 or 56 Days Treatment With Inhaled Tobramycin Nebuliser Solution for Pseudomonas Aeruginosa Infection in Children With Cystic Fibrosis. [Active, not recruiting]
This study assesses time to recurrence of infection with Pseudomonas aeruginosa following treatment of the initial infection with tobramycin nebuliser solution. The safety of the initial tobramycin treatment will be monitored over the first 3 months of the study and patients will be followed for a further 24 months.

Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis [Recruiting]
This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

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