The Ora CAE® Model: Accelerating Dry Eye Research
The CAE model creates the ideal paradigm for identifying:
1) an enriched population of dry eye subjects with modifiable signs and symptoms and
2) endpoints for intervention that show relevant change.
When subjects are exposed to a controlled adverse environment (CAE®) in terms of relative humidity, temperature, airflow and visual tasking, the ocular surface is stressed to react. This controlled environmental stress creates a consistent response that is reproducible over time. A CAE® study derived-dataset has greater precision in predicting the efficacy of your drug- with fewer subjects, fewer sites and less time expended.
Our Mobile Dry Eye Units enable multi-center dry eye trials while still reducing clinical variables among sites.
The CAE® Model
- can be tailored to the MOA of the therapeutic to be tested
- can be used as an enrichment tool to identify and enroll the appropriate patient population for each study design
- can provide endpoints that demonstrate change with interventions
- can be used at any site or region with mobile units
We provide a menu of trial designs within the context of CAE®: from traditional endpoints, to CAE® model patient screening and enrichment, to a full CAE® trial with screening/patient enrichment and CAE®-specific endpoints of dry eye disease.