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

Autor: Ousler GW 3rd; Ora, Inc., 300 Brickstone Square, Andover, MA, 01810, USA., Rimmer D; Ora, Inc., 300 Brickstone Square, Andover, MA, 01810, USA., Smith LM; Ora, Inc., 300 Brickstone Square, Andover, MA, 01810, USA. lsmith@oraclinical.com., Abelson MB; Ora, Inc., 300 Brickstone Square, Andover, MA, 01810, USA.; Department of Ophthalmology, Harvard Medical School, Boston, MA, USA.
Jazyk: angličtina
Zdroj: Ophthalmology and therapy [Ophthalmol Ther] 2017 Dec; Vol. 6 (2), pp. 263-276. Date of Electronic Publication: 2017 Sep 27.
DOI: 10.1007/s40123-017-0110-x
Abstrakt: 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.
Databáze: MEDLINE