A study was conducted to determine the safety and efficacy of topicall
y applied ciprofloxacin ophthalmic solution in a pediatric population
experiencing acute bacterial conjunctivitis. Topically applied ciprofl
oxacin (3mg/mL) is known to be a safe and effective treatment for adul
ts suffering from bacterial conjunctivitis; however, the safety and ef
fectiveness of this broad-spectrum fluoroquinolone in pediatric patien
ts is not well established, Ciprofloxacin was evaluated in a double-bl
ind, randomized, controlled study of 257 patients ranging from 0 (i.e.
, less than 1 year) to 12 years of age from 33 geographically diverse
medical centers. The children received either 0.3% ciprofloxacin ophth
almic solution (Ciloxan(TM), Alcon Laboratories, Fort Worth, TX) or to
bramycin ophthalmic solution (Tobrex(TM), Alcon Laboratories, Fort Wor
th, TX), Both test medications were administered topically every 2 hou
rs on days 1 and 2 followed by every 4 hours on days 3 through 7, Eyes
were cultured prior to enrollment and again on day 7. Treatment effic
acy as determined by microbiological culture data and physicians' judg
ment of overall resolution was similar for the ciprofloxacin and tobra
mycin groups. Microbiological eradication tvas observed in 90.1% of th
e ciprofloxacin group and 84.3% of the tobramycin group (P = 0.29). Ph
ysicians judged 87.0% of the ciprofloxacin patients and 89.9% of the t
obramycin patients clinically cured on day 7 (P>0.5) There were no ser
ious adverse medical events attributable to either treatment, This stu
dy showed that topically applied ciprofloxacin ophthalmic solution is
safe and effective in a pediatric population experiencing acute bacter
ial conjunctivitis.