Abstract
Purpose :
The purpose of this study was to show that subjects with allergic conjunctivitis (AC) or allergic rhinoconjunctivitis (ARC) develop moderate to severe ocular allergic signs and symptoms following 90 minutes of exposure to ragweed or timothy grass pollen in a mobile Allergen BioCube (mABC).
The clinical validation of the mobile Allergen BioCube (mABC) was performed in this study. A stationary version of the ABC was previously validated and used to conduct studies assessing the efficacy of drugs in the treatment of allergic rhinitis.
Methods :
Subjects with a self-reported history of ocular allergic symptoms for the last 2 consecutive years during the ragweed or timothy grass seasons who had a positive skin test reaction to ragweed or timothy grass pollen within 24 months of Visit 1 were screened for this study. Subjects were exposed to either ragweed or timothy grass pollen in the mABC for 90 minutes and assessments were made at specified intervals (0, 10, 30, 60, and 90 minutes). A qualifying score was defined as a bilateral score of 2 or greater for both ocular itching and redness using standardized 0-4 severity scales at 90 minutes post-exposure.
Results :
All subjects were asymptomatic prior to entering the mABC. All subjects experienced an increase in severity of ocular and nasal symptoms upon pollen exposure. Sixty (60%) percent of patients developed qualifying levels of bilateral ocular itching (mean score 2.7) and redness (mean score 3.1) at 90 minutes post-exposure. These subjects had a clinically (>1) and statistically (P<0.05) meaningful increase from baseline in all ocular and nasal allergic parameters at 90 minutes.
Conclusions :
The mABC was effective in inducing ocular allergic signs and symptoms in subjects with a history of AC/ARC over a 90-minute exposure period. The mABC will be an important tool for evaluating allergy therapeutics in clinical studies requiring an environmental allergy model across multiple ophthalmology/allergy centers.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.