The Controlled Adverse Environment (CAE®)
The CAE® offers a standardized approach to studying dry eye treatments, reducing standard deviations and data variability.
Well Controlled Trials
Ora's network of experienced investigators and precise evaluation methods and scales reduce variability between sites.
Validated Clinical Endpoints
Used in conjunction with Ora’s validated methods and grading scales, the CAE® provides critical endpoints.
Appropriate Patient Population
The model includes a key screening phase to select the appropriate sub-population to match each trial design.
Innovated by Ora, the Controlled Adverse Environment (CAE®) is a technologically advanced clinical model that provides a standardized approach to studying investigational treatments of dry eye.
The model exacerbates the signs and symptoms of dry eye (e.g. corneal staining and ocular discomfort) in a controlled manner by regulating humidity, temperature, airflow, lighting conditions and visual tasking within the CAE® chamber. Our Mobile Dry Eye Units enable multi-center dry eye trials while still reducing clinical variables among sites.
By integrating specific diagnostic equipment, the CAE® is able to measure both objective and subjective parameters according to standardized methods and scales, including Ocular Protection Index (OPI) – developed by Ora to evaluate ocular surface protection under a natural blink pattern and normal visual conditions, tear film breakup time (TFBUT), and Ora’s Calibra Scales for staining, redness, comfort, and discomfort.
The CAE® model can be customized to accentuate the specific mechanism of action of novel test agents. Using the CAE® model in conjunction with Ora’s methods and refined clinical scales, a variety of clinical signs and symptoms can be evaluated before, during, and after CAE® exposure to determine critical dry eye endpoints that meet regulatory standards. The CAE® model is also used as a key component in determining appropriate patient populations and screening subjects for dry eye clinical trials; thus large numbers of patients can be studied at fewer sites, lowering standard deviations and accelerating timelines.
Ora’s CAE® model removes the variables along the dry eye clinical pathway.