ArticleClinical drug investigation2010
Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies.
Article in Clinical drug investigation, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.
What it found
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Who cites it
7 citing papers in PubMed, 16 citations in OpenAlex.
- The safety of besifloxacin ophthalmic suspension 0.6 % used three times daily for 7 days in the treatment of bacterial conjunctivitis.Drugs in R&D · 2013Trial
- Besifloxacin ophthalmic suspension 0.6% administered twice daily for 3 days in the treatment of bacterial conjunctivitis in adults and children.Clinical drug investigation · 2012Trial
- Besifloxacin: Efficacy and Safety in Treatment and Prevention of Ocular Bacterial Infections.Ophthalmology and therapy · 2016Review
- Contribution of the R8 substituent to the in vitro antibacterial potency of besifloxacin and comparator ophthalmic fluoroquinolones.Clinical ophthalmology (Auckland, N.Z.) · 2013Article
- Safety of besifloxacin ophthalmic suspension 0.6% as a prophylactic antibiotic following routine cataract surgery: results of a prospective, parallel-group, investigator-masked study.Clinical ophthalmology (Auckland, N.Z.) · 2012Article
- The role of topical moxifloxacin, a new antibacterial in Europe, in the treatment of bacterial conjunctivitis.Clinical drug investigation · 2011Article
- Besifloxacin ophthalmic suspension: emerging evidence of its therapeutic value in bacterial conjunctivitis.Ophthalmology and eye diseases · 2011Article
Corrections and comments
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Authors and funding
4 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundBesifloxacin is a novel fluoroquinolone, specifically a chloro-fluoroquinolone, with potent broad-spectrum bactericidal activity for the topical treatment of bacterial conjunctivitis.
objectiveThe objective of this report was to provide a comprehensive assessment of the safety and tolerability of besifloxacin ophthalmic suspension 0.6% across clinical and phase I safety studies.
methodsData were drawn from two phase I safety studies in healthy adults, an open-label, phase II pharmacokinetic study of patients with bacterial conjunctivitis and from integrated data from three randomized, double-masked, parallel-group, safety and efficacy studies of patients with bacterial conjunctivitis (two were vehicle controlled and one was active controlled with moxifloxacin ophthalmic solution 0.5%, as base). Safety assessments included changes in visual acuity, ocular assessments with ophthalmoscopy and biomicroscopy, and assessment of adverse events (AEs).
resultsSafety data for besifloxacin ophthalmic suspension 0.6% were available for 1350 patients, including 1192 patients (1810 eyes) in the integrated analysis. Systemic exposure following topical administration of besifloxacin ophthalmic suspension 0.6% was negligible. No changes were seen in corneal endothelial cell density. In the integrated safety analysis of the three safety and efficacy studies, the most commonly reported ocular AEs in study eyes receiving besifloxacin ophthalmic suspension 0.6% were blurred vision (2.1%), eye pain (1.8%), eye irritation (1.4%), nonspecific conjunctivitis (1.2%) and eye pruritus (1.1%). Blurred vision, eye irritation and nonspecific conjunctivitis occurred in significantly fewer besifloxacin-treated patients than in vehicle-treated patients (p < or = 0.05). Headache (1.8%) was the most frequently reported non-ocular AE. Most AEs were mild in severity and there were no treatment-related serious AEs. Besifloxacin ophthalmic suspension 0.6% did not significantly affect visual acuity, biomicroscopy or ophthalmoscopy compared with vehicle or moxifloxacin.
conclusionThe results from this comprehensive data set of 1350 patients demonstrate that besifloxacin ophthalmic suspension 0.6% has a favourable safety profile and is well tolerated.
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