CAE

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.