Ousler, George W.Rimmer, DavidSmith, Lisa M.Abelson, Mark2017-12-062017Ousler, George W., David Rimmer, Lisa M. Smith, and Mark B. Abelson. 2017. “Use of the Controlled Adverse Environment (CAE) in Clinical Research: A Review.” Ophthalmology and Therapy 6 (2): 263-276. doi:10.1007/s40123-017-0110-x. http://dx.doi.org/10.1007/s40123-017-0110-x.http://nrs.harvard.edu/urn-3:HUL.InstRepos:34493184The 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.en-USAqueous-deficient dry eyeClinical trialsControlled adverse environmentDisease modelsDrug screeningDry eye diseaseEfficacy endpointsEvaporative dry eyeKeratitisOcular discomfortTear film break upTear film deficiencyJournal Article2017-12-0610.1007/s40123-017-0110-x