Safety of Ophthalmic Moxifloxacin in the Treatment of Newborns, Infants and Toddlers, Children, and Adolescents With Bacterial Conjunctivitis

Abstract

Abstract: : Purpose: To determine the safety of Moxifloxacin Ophthalmic Solution 0.5% in treating pediatric and non-pediatric patients with bacterial conjunctivitis. Methods: In four clinical trials (Phases II/III), a total of 728 pediatric and non-pediatric patients was exposed to Moxifloxacin Ophthalmic Solution 0.5% (BID or TID) and evaluated for safety. The entire pediatric population consisted of 336 patients in the following age groups: 100 newborn infants (0 to 27 days), 44 infants and toddlers (28 days to 23 months), 152 children (2 to 11 years) and 40 adolescents (12 to 17 years). The non-pediatric population consisted of 352 adult (18 to 64 years) and 40 elderly (≥65 years) patients. Results: The most frequent adverse events in the combined Moxifloxacin pediatric population were ocular discomfort (1.8%) and unrelated upper respiratory infection (2.7%) which were similar in incidence in the Placebo (Vehicle) group. Overall, no clinically relevant differences in adverse events were observed between pediatric and non-pediatric patients and no trends were observed in the analysis of adverse events by age. Additionally, no safety concerns were observed in any age group based upon measured ocular and nonocular safety parameters (i.e., visual acuity, ocular signs, fundus parameters, and cardiovascular parameters). Conclusions: Moxifloxacin Ophthalmic Solution 0.5% is as safe in pediatric patients as in non-pediatric patients with bacterial conjunctivitis.

Keywords: conjunctivitis • clinical (human) or epidemiologic studies: tre • bacterial disease