Leonard Bielory1. 1. Div. Allergy, Immunology, and Rheumatology, Clinical Research and Development, Dept. of Medicine, Pediatrics, and Ophthalmology, University of Medicine and Dentistry of New Jersey-New Jersey Medical School, Newark, New Jersey 07103, USA. bielory@umdnj.edu
Abstract
BACKGROUND:Allergic rhinitis (AR) is more appropriately termed allergic rhinoconjunctivitis owing to the equally bothersome nasal and ocular symptoms. Extensive evidence supports the ability of intranasal corticosteroids to reduce nasal symptoms of AR, although less evidence is available to define clearly their impact on allergic conjunctivitis. OBJECTIVE: To determine the effect of the intranasal corticosteroid mometasone furoate nasal spray (NS) on the ocular symptoms of seasonal AR. METHODS: This retrospective pooled analysis of 4 placebo-controlled clinical studies randomized patients 12 years and older with symptomatic seasonal AR to receivemometasone furoate NS, 200 microg once daily (n = 491), or placebo (n = 492). Ocular symptom (eye tearing [epiphora], itching [pruritus], and redness [erythema]) severity was rated by patients twice daily on a 4-point scale (0 = none to 3 = severe) in the morning and evening, with scores averaged to obtain a daily mean score. Efficacy variables were the pooled mean change from baseline in the averaged morning and evening total ocular symptom score (TOSS) and the individual ocular symptom scores. RESULTS: The change in mean TOSS from baseline to days 1 to 15 was -1.33 (-19.8%) with mometasone furoate NS and -0.93 (-5.6%) with placebo (P < .001). Improvements in individual symptoms were significantly better with mometasone furoate NS than with placebo on days 2 (tearing) and 4 (itching and redness). A slightly greater reduction in TOSS was seen with mometasone furoate NS treatment in the evening than in the morning. CONCLUSIONS: This detailed analysis of an intranasal corticosteroid on individual ocular symptoms supports the positive impact of mometasone furoate NS on ocular symptoms.
RCT Entities:
BACKGROUND:Allergic rhinitis (AR) is more appropriately termed allergic rhinoconjunctivitis owing to the equally bothersome nasal and ocular symptoms. Extensive evidence supports the ability of intranasal corticosteroids to reduce nasal symptoms of AR, although less evidence is available to define clearly their impact on allergic conjunctivitis. OBJECTIVE: To determine the effect of the intranasal corticosteroid mometasone furoate nasal spray (NS) on the ocular symptoms of seasonal AR. METHODS: This retrospective pooled analysis of 4 placebo-controlled clinical studies randomized patients 12 years and older with symptomatic seasonal AR to receive mometasone furoate NS, 200 microg once daily (n = 491), or placebo (n = 492). Ocular symptom (eye tearing [epiphora], itching [pruritus], and redness [erythema]) severity was rated by patients twice daily on a 4-point scale (0 = none to 3 = severe) in the morning and evening, with scores averaged to obtain a daily mean score. Efficacy variables were the pooled mean change from baseline in the averaged morning and evening total ocular symptom score (TOSS) and the individual ocular symptom scores. RESULTS: The change in mean TOSS from baseline to days 1 to 15 was -1.33 (-19.8%) with mometasone furoate NS and -0.93 (-5.6%) with placebo (P < .001). Improvements in individual symptoms were significantly better with mometasone furoate NS than with placebo on days 2 (tearing) and 4 (itching and redness). A slightly greater reduction in TOSS was seen with mometasone furoate NS treatment in the evening than in the morning. CONCLUSIONS: This detailed analysis of an intranasal corticosteroid on individual ocular symptoms supports the positive impact of mometasone furoate NS on ocular symptoms.