Efficacy and safety of 0.5% levofloxacin ophthalmic solution for the treatment of bacterial conjunctivitis in pediatric patients*1

Abstract

A randomized, double-masked, multicenter, parallel study was conducted to compare the efficacy and safety of 0.5% levofloxacin ophthalmic solution (Quixin; Santen, Napa, CA) with 0.3% ofloxacin (Ocuflox; Allergan Inc, Irvine, CA) and placebo for the treatment of pediatric bacterial conjunctivitis. One hundred and sixty seven patients between the age of 1 and 16 years with a clinical diagnosis of bacterial conjunctivitis were randomized for treatment with 0.5% levofloxacin, ofloxacin, or placebo. Eyedrops were instilled every 2 hours on days 1 and 2 and every 4 hours on days 3 through 5. Conjunctival cultures were obtained on day 1 (baseline), days 3 to 5 (interim), and days 6 to 10 (final). Ocular cardinal signs (conjunctival discharge, bulbar conjunctival injection, palpebral conjunctival injection) and symptoms (burning and stinging, tearing, itching, foreign body sensation, photophobia, and discomfort) were graded using a four-point scale. Ocular safety was determined by evaluating the incidence and severity of adverse events and significant changes from baseline in biomicroscopy, ocular symptoms, visual acuity, and ophthalmoscopy. At endpoint, 0.5% levofloxacin treatment demonstrated greater microbial eradication rates compared with 0.3% ofloxacin or placebo. In children age 2 to 11 years this finding was statistically significant in favor of 0.5% levofloxacin versus ofloxacin (P < .032) and placebo (P < .001). In the same age range, the clinical cure rate of 0.5% levofloxacin was statistically superior to placebo (P < .034), and similar to that of 0.3% ofloxacin. Resolution of ocular signs and symptoms was consistently higher with 0.5% levofloxacin compared to placebo and similar to that achieved with 0.3% ofloxacin. All three treatments were safe and well tolerated. The conclusion is that 0.5% levofloxacin is safe and effective in the treatment of pediatric bacterial conjunctivitis.—Michael D. Wagoner