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Paul J Gomes, J. Ernest Villafranca, Erik Viirre, Elliott Lasser, Mark B Abelson; Reducing nasal and ocular itching with a novel drug in the BioCube® allergy chamber. Invest. Ophthalmol. Vis. Sci. 2016;57(12):305.
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© ARVO (1962-2015); The Authors (2016-present)
The Allergen BioCube® is a controlled environment model that provides precise measurements of allergic rhinoconjunctivitis (AR) signs and symptoms. This study evaluated Nasapaque, an iodinated contrast agent (iodixanol, 3E Therapeutics), compared to placebo for treatment of AR nasal and ocular symptoms induced in the BioCube (Ora).
Consistent and reproducible allergen levels in the BioCube were used to provide reliable assessments of individual nasal and ocular symptoms as well as Total Nasal Symptom Score and Total Ocular Symptom Score (0 to 3 scale, 0=none, 3=severe), evaluated pre- and post-treatment (every 5 min for 30 min, then every 15 min) for 7.5 hrs at Visit 4 and 3.5 hrs at Visit 5. This was a single-center, double-masked, randomized, placebo-controlled, 5-visit study (N=73). Screening occurred at Visit 1. Subjects were primed for ragweed exposure in the Biocube for 3 hrs at Visits 2 and 3. Entry criteria included history of AR, positive skin test for ragweed, and a positive Biocube challenge response (TNSS ≥ 6) to ragweed after 90 min of Biocube exposure at Visit 4. Topical nasal treatment with Nasapaque or placebo occurred following 90-min ragweed exposure in the Biocube (Visit 4) and 30 min prior to ragweed exposure in the Biocube (Visit 5).
Nasapaque-treated subjects reported greater reductions from baseline compared to placebo (Visit 4). Results were statistically significant for nasal itching (baseline: drug=2.3±0.63, placebo=2.1±0.74), with maximum statistically significant (p ≤ 0.05) mean differences at 2 hr 45 min (drug=-1.2, placebo=-0.7, p=0.01); and for ocular itching (baseline: drug=2.2±0.81, placebo=1.9±0.86) at 2 hr 45 min (drug=-1.1, placebo=-0.8, p=0.04). Onset of action for nasal itching was 15 min, and for ocular itching was 10 min. For nasal itching, statistically significant differences in favor of Nasapaque lasted up to 4 hr 30 min (drug=-1.2, placebo=-0.8, p=0.04), with even longer efficacy for ocular itching of up to 5 hr 15 min (drug=-1.0, placebo=0.0, p=0.05). Thus results in the Biocube were clinically relevant for Nasapaque but not for placebo.
In this study Nasapaque nasal treatment in the Biocube resulted in significant reductions in both nasal and ocular itching, providing further evidence of a neuronal nasal-ocular reflex for ocular itching associated with allergic rhinoconjunctivitis.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
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