Safety and tolerability of besifloxacin ophthalmic suspension 0.6% in the treatment of bacterial conjunctivitis: data from six clinical and phase I safety studies.

Clinical Drug Investigation
Timothy L ComstockDale W Usner

Abstract

Besifloxacin is a novel fluoroquinolone, specifically a chloro-fluoroquinolone, with potent broad-spectrum bactericidal activity for the topical treatment of bacterial conjunctivitis. The 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. Data 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). Safety 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 endotheli...Continue Reading

References

Mar 8, 2003·Ophthalmology·Ivan R SchwabUNKNOWN Levofloxacin Bacterial Conjunctivitis Active Control Study Group
Jul 26, 2003·The British Journal of Ophthalmology·D G HwangUNKNOWN Levofloxacin Bacterial Conjunctivitis Place-controlled Study Group
Oct 21, 2003·Journal of AAPOS : the Official Publication of the American Association for Pediatric Ophthalmology and Strabismus·Steven J LichtensteinUNKNOWN Levofloxacin Bacterial Conjunctivitis Study Group
Jun 19, 2007·Ophthalmology·Kara CavuotoWilliam Feuer
Jun 27, 2007·Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics·Keith W WardJean-Yves Driot
Sep 1, 2007·Clinical & Experimental Ophthalmology·Andrew M Thompson
Oct 4, 2007·The Annals of Pharmacotherapy·Allana J Mehlhorn, Dana A Brown
Nov 1, 2007·Acta Ophthalmologica·Gunnar Høvding
Mar 28, 2009·Current Medical Research and Opinion·Michael E TepedinoTimothy L Comstock
Jun 6, 2009·Journal of Ocular Pharmacology and Therapeutics : the Official Journal of the Association for Ocular Pharmacology and Therapeutics·Joel W ProkschKeith W Ward
Jun 10, 2009·Antimicrobial Agents and Chemotherapy·Wolfgang HaasTimothy W Morris
May 4, 2010·The Journal of Antimicrobial Chemotherapy·Wolfgang HaasTimothy W Morris

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Citations

Jun 5, 2015·Canadian Journal of Ophthalmology. Journal Canadien D'ophtalmologie·Jean Deschênes, Joseph Blondeau
Sep 15, 2010·Optometry and Vision Science : Official Publication of the American Academy of Optometry·Paul KarpeckiTimothy L Comstock
May 25, 2011·Clinical Drug Investigation·Jose Benitez-Del-CastilloLaurent Kodjikian
Jan 19, 2018·Critical Reviews in Analytical Chemistry·Eliane Gandolpho Tótoli, Hérida Regina Nunes Salgado
Mar 25, 2016·Ophthalmology and Therapy·Francis S Mah, Christine M Sanfilippo
Feb 26, 2014·The Annals of Pharmacotherapy·Tracy D MahvanSuzanne Clark

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