Abstract
Purpose :
It has been previously reported that patients with dry eye disease (DED) who exhibit a rapid symptomatic response to the Ora CAE® challenge demonstrate enhanced investigational treatment differences as well as a reduction of placebo effects in clinical studies. The purpose of this study is to report the prevalence of this CAE hyper-response across treatment naïve dry eye patients.
Methods :
Data from 1209 DED patients were analyzed. The CAE is a controlled chamber which allows for highly standardized atmosphere of low relative humidity, increased airflow, and constant visual tasking. This controlled environment overcomes a dry eye subject’s ability to maintain a stable tear film and allows for reproducible evaluation of signs and symptoms of dry eye. Each subject’s ocular discomfort is documented using the Ora Calibra® Ocular Discomfort scale (0 = none to 4 = worst) before and periodically during the 90 minutes CAE challenge. A subject is defined as a CAE hyper-responder if their ocular discomfort worsens to 3 or greater (or to 4 if 3 at time 0) in less than 20 min in CAE (considered a more symptomatic patient or hyper-responder) versus ≥ 20 minutes in CAE (i.e. not hyper-responder). For each study, number of subjects identified as hyper-responders were documented and percentage was calculated.
Results :
Among the 1209 subjects, 496 (41%) were identified as CAE hyper-responders and 713 (59%) were not hyper-responders to the CAE. Overall reproducibility of subjects meeting these criteria at more than one CAE challenge was 787/1209 (65%). When considering a 10 min. window of the 90 min. challenge for re-qualification, CAE hyper-responders reproduced 79% of the time.
Conclusions :
Hyper-response to CAE is a phenomenon well-documented across a large number of patients. An individual DED patient’s inherent sensitivity to respond to a challenge might be a contributing factor and indicator of their ability to report symptoms and better distinguish treatment differences. Additional study is ongoing to identify specific individual characteristics that might be a related to exhibiting hyper-response on CAE. A hyper-response to the CAE as an inclusion criterion or pre-defined subpopulation may result in patient enrichment in dry eye clinical trials.
This is a 2021 ARVO Annual Meeting abstract.