Efficacy and Safety of Besifloxacin Ophthalmic Suspension 0.6% in Children and Adolescents with Bacterial Conjunctivitis

Comstock, Timothy L.; Paterno, Michael R.; Usner, Dale W; Pichichero, Michael E.

doi:10.2165/11534380-000000000-00000

Cited by 25 publications

(13 citation statements)

References 27 publications

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“…Table No. 6 shows the side effects of both eye drops in which burning sensation and foreign body sensation was significantly higher in azithromycin group than besifloxacin group supported by Comstock T Let al [17] which showed that Systemic exposure of besifloxacin was negligible and the most common adverse events in patients receiving topical besifloxacin were local and included blurred vision (2.1%), eye pain (1.8%), eye irritation (1.4%), nonspecific conjunctivitis (1.2%) and eye pruritis (1.1%). Besifloxacin topical administration did not affect visual acuity [18].…”

Section: International Journal Of Medical Research and Reviewmentioning

confidence: 85%

Clinical comparison of 0.6% besifloxacin ophthalmic suspension and 1.5% azithromycin ophthalmic suspension in acute bacterial conjunctivitis

Meena¹,

Gupta²

2015

Int J Med Res Rev

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Introduction: Acute bacterial conjunctivitis is one of the most common ocular infection seen in day to day clinical practice. Our purpose to conduct this study was to compare the outcome and efficacy of 0.6% besifloxacin ophthalmic suspension and 1.5% azithromycin ophthalmic suspension in acute bacterial conjunctivitis. Method: This is a Prospective, randomized, parallel-group, clinical study of acute bacterial conjunctivitis Conducted From July 2015 to Sept 2015 on 200 patients in the department of Ophthalmology at Jhalawar Medical College, Jhalawar.(raj.) All selected patients were divided into two groups of 100 each. Group A was treated by besifloxacin 0.6% ophthalmic suspension,where as group B was treated by 1.5% azithromycin ophthalmic suspension three times a day for 7 day. Observation was done on 3, 7 day regarding clinical resolution and side effect of these drugs in both groups. Result: Clinical resolution, complication , and side effects of these two drugs were analysed on day 3 and day 7 and found that 0.6% besifloxacin is significantly better than 1.5% azithromycin eye drop on day 3 and day 7 (p value<0.5) and also have less side effect (p value<0.5).Conclusion: 0.6% besifloxacin is safe and efficacious in acute bacterial conjunctivitis in all age group.

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Section: International Journal Of Medical Research and Reviewmentioning

confidence: 85%

Clinical comparison of 0.6% besifloxacin ophthalmic suspension and 1.5% azithromycin ophthalmic suspension in acute bacterial conjunctivitis

Meena¹,

Gupta²

2015

Int J Med Res Rev

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“…A post hoc analysis of data from 815 pediatric patients (447 with culture-confirmed bacterial conjunctivitis) who had participated in the three clinical trials confirmed that besifloxacin maintained its clinical and antimicrobial efficacy in children and adolescents (1–17 years of age) [ 61 ]. In a multicenter, randomized study of 33 neonatal patients (≤31 days of age) with presumed bacterial conjunctivitis, besifloxacin 0.6% and gatifloxacin 0.3% given three times daily for seven days demonstrated similar efficacy, with high rates of clinical resolution (over 70%) and microbial eradication (about 90%) for both groups on day 8 or 9 [ 62 ].…”

Section: Resultsmentioning

confidence: 99%

“…In addition, besifloxacin was well-tolerated by the pediatric patients in the besifloxacin clinical trials dosed three times daily for 5 days ( N = 815), with similarly low incidences of ocular adverse events found in all treatment groups (besifloxacin, moxifloxacin, and vehicle) [ 61 ]. The most commonly reported adverse events in besifloxacin-treated eyes from pediatric patients were conjunctivitis (2.9%), bacterial conjunctivitis (2.1%), and eye pain (1.8%); headache, the only nonocular adverse event reported in more than 1% of patients, occurred in 1–2% of patients in each treatment group.…”

Section: Resultsmentioning

confidence: 99%

Besifloxacin: Efficacy and Safety in Treatment and Prevention of Ocular Bacterial Infections

Mah

Sanfilippo²

2016

Ophthalmol Ther

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This comprehensive review summarizes the mechanism of action, pharmacokinetics, efficacy, and safety of besifloxacin ophthalmic suspension, 0.6% and examines its role in the treatment of ocular surface bacterial infections. Besifloxacin possesses balanced activity against bacterial topoisomerase II (also called DNA gyrase) and topoisomerase IV. It has shown a low potential to select for bacterial resistance in vitro and demonstrated strong in vitro activity against many Gram-positive, Gram-negative, and anaerobic organisms, including methicillin-resistant Staphylococcus aureus and Staphylococcus epidermidis (MRSA and MRSE, respectively). Ocular pharmacokinetic studies have shown that besifloxacin achieves high, sustained concentrations in the tear fluid and conjunctiva following topical administration, with negligible systemic exposure. Large randomized, controlled clinical trials have established the efficacy and safety of besifloxacin administered three times daily for 5 days for treatment of acute bacterial conjunctivitis in both adults and children, with high rates of clinical resolution (up to more than 70% by day 5) and bacterial eradication (more than 90% by day 5), and a low incidence of adverse events. Additionally, besifloxacin applied twice daily for 3 days demonstrated greater efficacy than vehicle in treating bacterial conjunctivitis. Case reports, a large retrospective chart review, and animal studies have provided supporting evidence for the efficacy of besifloxacin in the management of acute bacterial keratitis. There is some evidence to suggest that besifloxacin may provide an advantage over other current-generation fluoroquinolones in antimicrobial prophylaxis for ocular surgery. Besifloxacin is an appropriate option for treatment of bacterial conjunctivitis, and its use in the treatment of bacterial keratitis and lid disorders, as well as for surgical prophylaxis, appears promising and warrants further evaluation.

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“…Mehrere randomisierte, doppelblinde, kontrollierte Studien haben gute klinische Erfolgsraten bei der Behandlung der bakteriellen Konjunktivitis von 66 -96 % und Bakterienelimination bei 84 -96 % nachgewiesen [35]. Topisches Levofloxacin, Moxifloxacin und Besifloxacin wurden alle erfolgreich bei der kindlichen Konjunktivitis angewendet [4, 36,37]. Moxifloxacin ist bereits für Neugeborene zugelassen.…”

Section: Fluoroquinoloneunclassified

Bakterielle Konjunktivitis - Update zu Diagnose und Therapie

Messmer¹

2012

Klin Monatsbl Augenheilkd

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Acute bacterial conjunctivitis is a common health-care issue for the general practitioner and the ophthalmologist. Signs and symptoms usually allow a correct diagnosis without conjunctival swab. Primary microbiological investigations are recommended in newborns, immunocompromised patients and cases of hyperacute conjunctivitis. Of concern are methicillin-resistant Staphylococcus aureus strains which have been isolated with increasing frequency in the last few years. Studies have demonstrated the faster clinical and microbiological cure of acute bacterial conjunctivitis with topical antibiotics. However, the development of resistance of the typical germs to all of the antibiotic groups is alarming and should influence therapeutic behaviour. Fluoroquinolones show good activity in the treatment of acute bacterial conjunctivitis but should be saved for severe infections due to its broad spectrum of activity. Antibiotics such as gentamycin, tobramycin, and azithromycin should be preferred. Considering the high spontaneous healing rate of acute conjunctivitis, delayed topical antibiotics in case of persistence after 3-4 days, or treatment without antibiotics using artificial tears and eye bathings may be considered. Additive anti-inflammatory drugs are generally not recommended. Chronic-recurrent follicular conjunctivitis necessitates testing for Chlamydia, and in case of a positive result, systemic antibiotic treatment of patient and sexual partner.

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Efficacy and Safety of Besifloxacin Ophthalmic Suspension 0.6% in Children and Adolescents with Bacterial Conjunctivitis

Abstract: Besifloxacin ophthalmic suspension 0.6% was shown to be safe and effective for the treatment of bacterial conjunctivitis in children and adolescents aged 1-17 years.

Cited by 25 publications

References 27 publications

Clinical comparison of 0.6% besifloxacin ophthalmic suspension and 1.5% azithromycin ophthalmic suspension in acute bacterial conjunctivitis

Clinical comparison of 0.6% besifloxacin ophthalmic suspension and 1.5% azithromycin ophthalmic suspension in acute bacterial conjunctivitis

Besifloxacin: Efficacy and Safety in Treatment and Prevention of Ocular Bacterial Infections

Bakterielle Konjunktivitis - Update zu Diagnose und Therapie

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