May 06, 2003
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Study: Moxifloxacin deemed safe for use in pediatric patients

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FORT LAUDERDALE, Fla. — Pediatric patients with bacterial conjunctivitis can be safely treated with moxifloxacin, according to a study released by the drug’s manufacturer here at the Association for Research in Vision and Ophthalmology annual meeting.

In a poster presented here by members of the Alcon research team, moxifloxacin was studied in a group of 728 patients dosed with the drug either twice or three times daily, to evaluate adverse effects. The pediatric population consisted of 336 patients ranging from newborn (age 0 to 27 days) up to adolescents (age 12 to 17). The non-pediatric patient population consisted of 352 adults between 18 and 64 years of age and 40 elderly people.

Overall, there were few differences in adverse effects between pediatric and non-pediatric patients, the study showed. The pediatric patients did exhibit more ocular discomfort (1.8%) and upper respiratory infection (2.7%), but there was no indication that Vigamox was associated with these symptoms. These symptoms were similar in incidence in the placebo group.

There were no safety concerns observed in any age group based on the measured ocular and non-ocular safety parameters, such as visual acuity, ocular signs, fundus parameters and cardiovascular parameters.

Moxifloxacin, being marketed in the U.S. as Vigamox, should be available to physicians within the next week, company officials said Sunday.