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Tuyen Ong, Catherine Allaire, Timothy W Morris, Baldo Sforzolini; Besifloxacin Ophthalmic Suspension, 0.6% Compared with Gatifloxacin Ophthalmic Solution, 0.3% for the Treatment of Bacterial Conjunctivitis in Neonatal Patients. Invest. Ophthalmol. Vis. Sci. 2014;55(13):5790.
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To evaluate the safety and efficacy of topical besifloxacin ophthalmic suspension, 0.6% compared with gatifloxacin ophthalmic solution, 0.3% in the treatment of neonatal patients with bacterial conjunctivitis.
Multicenter, randomized, double-masked, parallel group study. Patients ≤31 days of age with a severity of grade ≥1 conjunctival discharge and conjunctival hyperemia were randomized to besifloxacin or gatifloxacin instilled in the infected eye(s) 3 times daily for 7 days and completed 5 study visits (3 clinic visits and 2 phone calls). Primary endpoints included clinical resolution (absence of both conjunctival discharge and conjunctival hyperemia) at Visit 5 (Day 8 or 9) and rates of ocular and non-ocular treatment emergent adverse events (AEs). Microbial eradication was a secondary endpoint.
Thirty three patients (33 eyes) were randomized. Mean (±SD) age of patients was 15.5 (6.0) days and 57.6% were female. Of these, 22 patients (22 eyes) had culture-confirmed bacterial conjunctivitis, most often with gram-positive bacteria. Day 8 clinical resolution and microbial eradication appeared similar between treatment groups. One ocular AE considered unrelated to study treatment was reported (mild bacterial conjunctivitis in a treated fellow eye of a gatifloxacin-treated patient). There were no treatment related non-ocular AEs.
In this study with neonatal patients, both besifloxacin and gatifloxacin appeared effective and safe in the treatment of bacterial conjunctivitis.
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