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L. M. Pozza, A. Salapatek, D. Patel, J. Pipkin, R. Zimmerer, Jr., P. Patel; Ocular Symptoms Are Significantly Improved by Budesonide Nasal Solution (Captisol-Enabled®) Compared to Micronized Suspension (Rhinocort Aqua®) or Placebo in Patients With Seasonal Allergic Conjunctivitis (SAC) Studied in an Environmental Exposure Chamber (EEC) Model. Invest. Ophthalmol. Vis. Sci. 2008;49(13):423.
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To investigate the efficacy on ocular symptoms of Captisol-Enabled® budesonide nasal spray, a novel formulation whereby Captisol® is utilized to enhance the solubility of budesonide, a synthetic corticosteroid used to alleviate the symptoms of seasonal allergies.
A randomized, double-blind, placebo-controlled, 3-way, crossover study was conducted in which 63 SAC patients were exposed to a controlled level of ragweed pollen in an EEC. The study consisted of 3 treatment periods, each with 2-4 priming visits and 1 treatment day. Ocular symptoms of itchy/gritty eyes, red/burning eyes and tearing/watery eyes were assessed on a 0-3 scale at 15, 30, 45, 60, 90 and 120 min post-dose and every hour up to 10 hr. Area under the curve (AUC) was calculated on mean change from baseline and treatments compared using ANCOVA.
The mean AUC for itchy/gritty eyes demonstrated significant efficacy of Captisol-Enabled® budesonide (-4.21±7.00) over placebo (-2.10±6.62) (p=0.042). The mean AUC for tearing/watery eyes also demonstrated significant efficacy of Captisol-Enabled® budesonide (-3.05±7.08) over placebo (-1.67±6.66) (p=0.047). Unlike Captisol-Enabled® budesonide, micronized suspension (Rhinocort Aqua®) did not demonstrate significant efficacy compared to placebo in ocular symptoms. The effect of Captisol-Enabled® budesonide compared to placebo on itchy/gritty eyes was greatest at timepoints 1.5, 2 and 3 hr post-dose with changes from baseline of -0.70±0.84 (p=0.031), -0.67±0.83 (p=0.020) and -0.58±0.83 (p=0.044), respectively. Similarly, the effect on tearing/watery eyes was greatest at 3 hr with changes from baseline of -0.55±0.89 (p=0.004) and the effect on red/burning eyes was greatest at 0.5, 1 and 2 hr with changes from baseline of -0.47±0.74 (p= 0.010), -0.58±0.88 (p=0.030) and -0.55±0.97 (p=0.022), respectively. Based on the mean change from baseline, the onset of action for Captisol-Enabled® budesonide for improvement in itchy/gritty eyes was 1.5 hr. Captisol-Enabled® budesonide also demonstrated significance on itchy/gritty eyes over Rhinocort Aqua® at 0.5 hr (p=0.008) and 0.75 hr (p=0.014).
Nasal delivery of solubilized budesonide (Captisol-Enabled®) demonstrated significant efficacy in improving the ocular symptoms associated with ragweed allergy. Funding: Cydex Pharmaceuticals Inc
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