A Comparison of the Safety and Efficacy of Moxifloxacin and Ciprofloxacin in the Treatment of Presumed Bacterial Conjunctivitis in Neonatal Patients

Abstract

Abstract: : Purpose: To compare the safety and efficacy of Moxifloxacin Ophthalmic Solution, 0.5% (Moxi) with Ciprofloxacin Ophthalmic Solution, 0.3% (Cip) in neonatal patients with presumed bacterial conjunctivitis. Methods: 209 patients under one month of age were enrolled in this double-masked, parallel group study and were randomized to either Moxi or Cip. Eligible patients were between two and 31 days of age with at least mild ocular redness and/or conjunctival discharge. Patients were treated with the assigned study medication three times daily for four days. Patients were evaluated for ocular signs and safety on Days 1,2,3,4 and 5 with a test-of-cure visit on Day 9. Ocular cultures were obtained on Day 1 (before the start of treatment) and at the test-of-cure on Day 9. Results: Of the 142 patients culture positive on Day 1, 137 (70 Cip, 67 Moxi) were evaluable per protocol. Staphylococcus epidermidis was the most commonly cultured organism among all patients. Clinical cure rate was identical for the two treatment groups at test-of-cure (Moxi 80% vs. Cip 80%; p = 0.9667), although Moxi showed a somewhat higher rate for early cure on Days 2 (Moxi = 27%, Cip = 19%) and on Day 3 (Moxi = 34%; Cip = 31%). Microbiological eradication at the test-of-cure visit was 92% for Moxi compared to 87% for Cip. Both medications were well tolerated with no treatment related serious adverse events. No clinically relevant, treatment-related changes in ocular exam or cardiovascular exam parameters were observed in either treatment group. Conclusions: Moxifloxacin Ophthalmic Solution, 0.5% and Ciprofloxacin Ophthalmic Solution, 0.3% are safe and effective in patients under one month of age for the treatment of bacterial conjunctivitis.

Keywords: antibiotics/antifungals/antiparasitics • conjunctivitis • clinical (human) or epidemiologic studies: tre