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R.S. Wagner, P.A. D’Arienzo, S.J. Hallas, M.B. Thomson, A.M. Shapiro; A Comparative Study In a Normal Pediatric Population of the Relative Comfort of Moxifloxacin 0.5% Ophthalmic Solution versus a Tear Substitute . Invest. Ophthalmol. Vis. Sci. 2004;45(13):4936.
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Purpose: Assess the relative comfort and tolerability of moxifloxacin 0.5% ophthalmic solution (Vigamox®) versus a tear substitute in a normal pediatric population. Methods: Subject–masked, crossover design, 50 subject, aged 7–17 years study. At baseline all subjects received 1 drop of tear substitute (Tears Naturale® II) in each eye. At least 1 hour later, 1 drop of moxifloxacin was instilled in each eye. Subjects rated drop comfort immediately, 1 minute and 3 minutes after instillation using a 0 to 10 scale where ‘0’ was "very comfortable" to ‘10’ was "severely bad pain." Results: Mean comfort scores for the tear substitute and moxifloxacin were 2.14 and 1.81 immediately after instillation, 0.71 and 0.84 one minute after instillation, and 0.41 and 0.46 three minutes after instillation, respectively. No clinically or statistically significant differences in mean comfort were found between treatment groups (P > 0.05 at all time points). Conclusions: Moxifloxacin was as comfortable as a tear substitute in a normal pediatric population. Moxifloxacin does not contain benzalkonium chloride and has a near–neutral pH of 6.8. These attributes contribute to moxifloxacin’s comfort and tolerability in the treatment of bacterial conjunctivitis. Since moxifloxacin has a broad spectrum, is a fourth generation fluoroquinolone, and has been found to be as comfortable as a tear substitute, it can readily be hypothesized that its comfort and convenient three–times daily dosing regimen will lead to greater pediatric patient compliance.
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