Background: Allergen exposure chambers (AECs) are clinical facilities allowing for controlled exposure of subjects to allergens in an enclosed environment. AECs have contributed towards characterizing the pathophysiology of respiratory allergic diseases and the pharmacological properties of new therapies. In addition, they are complementary to and offer some advantages over traditional multicentre field trials for evaluation of novel therapeutics. To date, AEC studies conducted have been monocentric and have followed protocols unique to each centre. Because there are technical differences among AECs, it may be necessary to define parameters to standardize the AECs so that studies may be extrapolated for driving basic immunological research and for marketing authorization purposes by regulatory authorities. Methods: For this task force initiative of the European Academy of Allergy and Clinical Immunology (EAACI), experts from academia and regulatory agencies

Blink is a complex phenomenon that is profoundly affected by diverse endogenous and exogenous stimuli. It has been studied in the context of cognition, emotional, and psychological states, as an indicator of fatigue and sleepiness, particularly in the automobile and transportation industry, in visual tasking, and finally, as it relates to tear film stability and ocular surface health. The fact that it is highly variable and has input from so many sources makes it very difficult to study. In the present review, the behavior of blink in many of these systems is discussed, ultimately returning in each instance to a discussion of how these factors affect blink in the context of dry eyes. Blink is important to ocular surface health and to an individual's optimal functioning and quality of life. Disturbances in blink, as cause or effect, result in a breakdown of tear film stability, optical clarity, and visual function.

An objective, automated analysis of corneal staining provides a quality assurance tool to be used to substantiate clinical grading of key corneal staining endpoints in multicentered clinical trials of dry eye.

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PurposeThe Ocular Protection Index (OPI) 2.0 System was developed to evaluate ocular surface protection under a natural blink pattern and normal visual conditions. The OPI 2.0 System implements fully automated software algorithms which provide a real-time measurement of corneal exposure (breakup area) for each interblink interval during a 1-minute video. Utilizing this method, the mean breakup area (MBA) and OPI 2.0 (MBA/interblink interval) were calculated and analyzed. The purpose of this study was to verify and validate the OPI 2.0 System for its ability to distinguish between dry eye and normal subjects, and to accurately identify breakup area.MethodsIn order to verify and validate the OPI 2.0 System, a series of artificial images and a series of still image frames captured during an actual clinical session using fluorescein staining videography were analyzed. Finally, a clinical validation process was completed to determine the effectiveness and clinical relevance of the OPI 2.0 System to differentiate between dry eye and normal subjects.ResultsSoftware analysis verification conducted in a set of artificially constructed images and in actual videos both saw minimal error rates. MBA and OPI 2.0 calculations were able to distinguish between the qualifying eyes of dry eye and normal subjects in a statistically significant fashion (P < 0.001 for both outcomes). As expected, dry eye subjects had a higher MBA and OPI 2.0 than normal subjects (0.232, dry eye; 0.040, normal and 0.039, dry eye; 0.006, normal, respectively). Results for the worst eyes and all qualifying analyses based on staining, forced-stare tear film breakup time, and MBA were numerically similar.ConclusionThe OPI 2.0 System accurately identifies the degree of breakup area on the cornea and represents an efficient, clinically relevant measurement of the pathophysiology of the ocular surface.