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G. W. Ousler, III, M. B. Abelson, D. L. Welch; Enhanced Precision of the Controlled Adverse Environment (CAE) System. Invest. Ophthalmol. Vis. Sci. 2010;51(13):3362.
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Successful study of dry eye therapies requires the use of standardized clinical models that generate reproducible results. Researchers at Ora, Inc developed the enhanced CAE system due to the evolving knowledge of dry eye subgroups, evolution of clinical grading scales, inclusion and exclusion criteria and time points. The purpose of this research was to evaluate the variability of clinical findings using the enhanced CAE system.
The variability of signs and symptoms were assessed using data on file from studies using the enhanced CAE system and historical data from studies using the classic CAE. The enhanced CAE system incorporated advances in the technology and design, allowing for evaluation during CAE exposure, during recovery periods after CAE exposure, and during environmental exposure between CAE exposures.
The ranges of standard deviations (SD) for ocular discomfort and corneal staining as measured using the enhanced CAE system were substantially lower than those recorded using the classic CAE.
The results of the present research demonstrate the increased precision in the signs and symptoms of dry eye when assessed using the enhanced CAE system. The data illuminate the successful evolution of the CAE trial design by incorporating substantial technological and design improvements in the enhanced CAE system. Ongoing research using the enhanced CAE system may confer advanced identification of disease sub-groups and improved precision in clinical endpoints, as well as continuing to promote pharmacological success in the future.
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