Efficacy and Safety of Besifloxacin Ophthalmic Suspension 0.6% Compared with Moxifloxacin Ophthalmic Solution 0.5% for Treating Bacterial Conjunctivitis

McDonald, Marguerite B.; Protzko, Eugene; Brunner, Lynne S.; Morris, Timothy W.; Haas, Wolfgang; Paterno, Michael R.; Comstock, Timothy L.; Usner, Dale W

doi:10.1016/j.ophtha.2009.05.014

Cited by 74 publications

(93 citation statements)

References 31 publications

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“…The gelling capacity was determined by placing 100 μL of the preparation in a vial containing 2 mL of simulated tear fluid freshly prepared and equilibrated at 34°C and visually assessing the gel formation and noting the time for gelation and the time taken for the gel formed to dissolve (33). The concentrated simulated tear fluid (composition: NaCl 6.8 g, NaHCO 3 2.2 g, CaCl 2 ⋅2H 2 O 0.08 g, KCl 1.4 g, and water to 100 mL) was made with ultrapure water as a solvent and mixed with the preparation in order to investigate the effects of ions in tear fluid on the gel strength and the consequences of dilution due to the ocular protective mechanisms.…”

Section: Preparation Of Formulationsmentioning

confidence: 99%

In Situ Gelling Gelrite/Alginate Formulations as Vehicles for Ophthalmic Drug Delivery

Liu

Zhang

et al. 2010

AAPS PharmSciTech

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Abstract. The objective of this study was to develop an ion-activated in situ gelling vehicle for ophthalmic delivery of matrine. The rheological properties of polymer solutions, including Gelrite, alginate, and Gelrite/alginate solution, were evaluated. In addition, the effect of formulation characteristics on in vitro release and in vivo precorneal drug kinetic of matrine was investigated. It was found that the optimum concentration of Gelrite solution for the in situ gel-forming delivery systems was 0.3% (w/w) and that for alginate solution was 1.4% (w/w). The mixture of 0.2% Gelrite and 0.6% alginate solutions showed a significant enhancement in gel strength at physiological condition. On the basis of the in vitro results, the Gelrite formulations of matrine-containing alginate released the drug most slowly. For each tested polymer solution, the concentration of matrine in the precorneal area was higher than that of matrinecontaining simulated tear fluid (STF) almost at each time point (p<0.05). The area under the curve of formulation 16 (0.2%Gelrite/0.6%alginate) was 4.65 times greater than that of containing matrine STF. Both the in vitro release and in vivo pharmacological studies indicated that the Gelrite/alginate solution had the better ability to retain drug than the Gelrite or alginate solutions alone. The tested formulation was found to be almost non-irritant in the ocular irritancy test. The overall results of this study revealed that the Gelrite/alginate mixture can be used as an in situ gelling vehicle to enhance ocular retention.

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Section: Preparation Of Formulationsmentioning

confidence: 99%

In Situ Gelling Gelrite/Alginate Formulations as Vehicles for Ophthalmic Drug Delivery

Liu

Zhang

et al. 2010

AAPS PharmSciTech

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“…Previous multicenter, randomized, double-masked, controlled clinical studies have established the safety and efficacy of besifloxacin ophthalmic suspension 0.6% for the treatment of bacterial conjunctivitis, whether administered thrice daily for 5 days [53][54][55] or twice daily for 3 days. 56 In each of these studies, clinical efficacy was demonstrated for patients with culture-confirmed bacterial conjunctivitis when pooling infections by all causative pathogens (Table 1) and also in the following subsets: infections due to Gram-positive pathogens; infections due to Gram-negative infections; and infections due to H. influenzae, S. pneumoniae, S. aureus, or S. epidermidis, the most prevalent bacterial pathogens in these studies.…”

Section: Discussionmentioning

confidence: 99%

“…Individual study results have been published previously. [53][54][55][56] The active comparator study 55 and two of the vehicle-controlled studies 53,54 employed a 5-day thrice-daily treatment regimen, while the third vehicle-controlled study 56 employed a 3-day twice-daily treatment regimen (Table 1).…”

Section: Methodsmentioning

confidence: 99%

“…[53][54][55][56] Briefly, eligible patients were aged $1 year with a diagnosis of bacterial conjunctivitis, as evidenced by a severity for both purulent ocular discharge and bulbar conjunctival injection of grade 1 or higher on a 4-point scale (0= absent, 1= mild, 2= moderate, and 3= severe) in at least one eye, and had a pinhole visual acuity (VA) of 20/200 or better in both eyes. The severity of bulbar conjunctival injection was determined using photographic standards (Ora Calibra TM Bacterial Conjunctivitis Bulbar Conjunctiva Redness Scale; Ora Inc., North Andover, MA, USA) employed in previous conjunctivitis research.…”

Section: Methodsmentioning

confidence: 99%

“…Samples for microbial cultures were taken from the conjunctival cul-de-sac of the affected eye(s), and patients were randomized to study treatment. Patients were instructed to administer one drop of study medication in the affected eye(s) three times daily at approximately 6-hour intervals for 5 days, [53][54][55] or twice daily at approximately 8-hour intervals during waking hours for a total of 3 days. 56 Patients returned to the study site at or near the end of treatment (visit 2, day 5 [±1] 53,55 or day 4 or 5 54,56 ) and after treatment ended on days 7 through 9 (visit 3, day 8 or 9 [53][54][55] ) for clinical assessment of ocular signs and symptoms, VA testing, biomicroscopy, ophthalmoscopy (visit 3 only), and culture of infected eye(s).…”

Section: Methodsmentioning

confidence: 99%

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Clinical outcomes with besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis due to potentially consequential pathogens

Comstock¹,

Morris²,

Gearinger³

et al. 2014

OPTO

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Purpose: Besifloxacin is a chlorofluoroquinolone approved for use in the treatment of bacterial conjunctivitis. This study assessed the clinical efficacy of besifloxacin ophthalmic suspension 0.6% against conjunctivitis infections caused by potentially consequential pathogens. Design: Post hoc analysis of clinical outcomes for patients with conjunctival infections due to Pseudomonas aeruginosa, Serratia marcescens, Neisseria spp., methicillin-resistant Staphylococcus aureus (MRSA), and methicillin-resistant Staphylococcus epidermidis (MRSE) who were treated with besifloxacin in four multicenter, double-masked, randomized clinical trials. Methods: Minimum inhibitory concentrations (MICs) of besifloxacin against potentially consequential pathogens were pooled. Clinical outcome data for patients treated with besifloxacin with baseline infections due to these pathogens were pooled and summarized. Bacterial eradication was defined as the absence of ocular bacterial species present at or above threshold at baseline. Results: A total of 1,317 patients had culture-confirmed bacterial conjunctivitis across the four studies, and 151 infections were due to the aforementioned pathogens (P. aeruginosa n=9; S. marcescens n=10; Neisseria spp. n=16; MRSA n=35; MRSE n=81). Among MRSA and MRSE infections, 48.3% demonstrated concurrent ciprofloxacin resistance (ciprofloxacinresistant [CipR]-MRSA n=24; CipR-MRSE n=32). The MIC 90 (MIC for 90% of isolates) for besifloxacin was 1 µg/mL for S. marcescens, 0.25 µg/mL for Neisseria spp., 0.06 µg/mL for both ciprofloxacin-sensitive MRSA and ciprofloxacin-sensitive MRSE, and 4 µg/mL for both CipR-MRSA and CipR-MRSE. Against P. aeruginosa, the MIC range was 1-4 µg/mL. Bacterial eradication rates in patients treated with besifloxacin were 100% by the first follow-up visit for infections due to P. aeruginosa, S. marcescens, and Neisseria spp. and 87.8% by the second follow-up visit for infections due to MRSA and MRSE. Conclusion: The use of besifloxacin ophthalmic suspension 0.6% in the treatment of conjunctival infections due to potentially consequential pathogens resulted in high rates of bacterial eradication.

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Conjunctivitis

Azari

Barney

2013

JAMA

435

312

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Efficacy and Safety of Besifloxacin Ophthalmic Suspension 0.6% Compared with Moxifloxacin Ophthalmic Solution 0.5% for Treating Bacterial Conjunctivitis

Cited by 74 publications

References 31 publications

In Situ Gelling Gelrite/Alginate Formulations as Vehicles for Ophthalmic Drug Delivery

In Situ Gelling Gelrite/Alginate Formulations as Vehicles for Ophthalmic Drug Delivery

Clinical outcomes with besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis due to potentially consequential pathogens

Conjunctivitis

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