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H.R. Katz, W. Andrews, D. Creager, J. De Leon, K. Merkley, L. Gower, D.W. Stroman, N. Nicholson, S. Potts, Moxifloxacin Study Group; Moxifloxacin Ophthalmic Solution 0.5% Hastens Cure and Eradicates the Causative Pathogens of Bacterial Conjunctivitis in Pediatric and Adult Patients . Invest. Ophthalmol. Vis. Sci. 2003;44(13):2114.
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Purpose: To evaluate the safety and efficacy of Moxifloxacin Ophthalmic Solution 0.5% [Moxi 0.5%] compared to Placebo in pediatric and adult patients with bacterial conjunctivitis. Methods: Five hundred forty-four patients, older than one month, with presumptive bacterial conjunctivitis were dosed three times daily [TID] for 4 days with either Moxi 0.5% or Placebo in a 9-day, multicenter, double-masked, prospective study. The primary clinical efficacy variable was the clinical cure rate of the two cardinal ocular signs of bacterial conjunctival infection, bulbar conjunctival injection and conjunctival discharge/exudate. Clinical cure was attained when the ratings of the two cardinal ocular signs were zero (i.e. normal or absent) approximately 5 days after the last dose, at the Day 9 test-of-cure (TOC) visit. Microbiological efficacy was bacterial eradication at the Day 9 TOC. Results: The results demonstrated that Moxi 0.5% was better than Placebo for microbiological success (82% vs. 67%; p=0.0069) and clinical cure (83% vs 74%; p=0.0991). Additionally, Moxi 0.5% was significantly more effective than Placebo for early cure at Day 3 (27% vs. 15%; p=0.0186) and at Day 5 (66% vs. 51%; p=0.0096). Prominent organisms eradicated by Moxi 0.5% were Staphylococcus epidermidis, Streptococcus pneumoniae, Staphylococcus aureus, other viridans Streptococcus, Haemophilus influenzae as well as strains resistant to earlier quinolones. Conclusions: Moxifloxacin 0.5% is effective in treating bacterial conjunctivitis. This effect is most evident by the early cures at Days 3 and 5. The results of the safety evaluation indicate that Moxifloxacin Ophthalmic Solution 0.5% is safe and well tolerated in patients older than one month when administered TID for 4 days.
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