Use of the Controlled Adverse Environment (CAE) in Clinical Research: A Review

George W Ousler 3rd, David Rimmer, Lisa M Smith, Mark B Abelson, George W Ousler 3rd, David Rimmer, Lisa M Smith, Mark B Abelson

Abstract

The many internal and external factors that contribute to the pathophysiology of dry eye disease (DED) create a difficult milieu for its study and complicate its clinical diagnosis and treatment. The controlled adverse environment (CAE®) model has been developed to minimize the variability that arises from exogenous factors and to exacerbate the signs and symptoms of DED by stressing the ocular surface in a safe, standardized, controlled, and reproducible manner. By integrating sensitive, specific, and clinically relevant endpoints, the CAE has proven to be a unique and adaptable model for both identifying study-specific patient populations with modifiable signs and symptoms, and for tailoring the evaluation of interventions in clinical research studies.

Keywords: Aqueous-deficient dry eye; Clinical trials; Controlled adverse environment; Disease models; Drug screening; Dry eye disease; Efficacy endpoints; Evaporative dry eye; Keratitis; Ocular discomfort; Tear film break up; Tear film deficiency.

Figures

Fig. 1
Fig. 1
Quantification of ocular surface damage by digital imaging

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