The CTFA Evaluation of Alternatives Program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase III) surfactant-based formulations

The CTFA Evaluation of Alternatives Program is an evaluation of the relationship between data from the Draize primary eye irritation test and comparable data from a selection of promising in vitro eye irritation tests. In Phase III, data from the Draize test and 41 in vitro endpoints on 25 representative surfactant-based personal care formulations were compared. As in Phase I and Phase II, regression modelling of the relationship between maximum average Draize score (MAS) and in vitro endpoint was the primary approach adopted for evaluating in vitro assay performance. The degree of confidence in prediction of MAS for a given in vitro endpoint is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curve. Prediction intervals reflect not only the error attributed to the model but also the material-specific components of variation in both the Draize and the in vitro assays. Among the in vitro assays selected for regression modeling in Phase III, the relationship between MAS and in vitro score was relatively well defined. The prediction bounds on MAS were most narrow for materials at the lower or upper end of the effective irritation range (MAS = 0-45), where variability in MAS was smallest. This, the confidence with which the MAS of surfactant-based formulations is predicted is greatest when MAS approaches zero or when MAS approaches 45 (no comment is made on prediction of MAS > 45 since extrapolation beyond the range of observed data is not possible). No single in vitro endpoint was found to exhibit relative superiority with regard to prediction of MAS. Variability associated with Draize test outcome (e.g. in MAS values) must be considered in any future comparisons of in vivo and in vitro test results if the purpose is to predict in vivo response using in vitro data.     

Potato gun ocular injury

PURPOSE: This study aimed to identify a dangerous new weapon capable of causing damage to the ocular and periocular regions. METHODS: The authors report two patients who had penetrating ocular injury in the past year because of homemade recreational potato guns. RESULTS: In one 14-year-old boy, projectiles from the firing of a potato gun resulted in orbital and cranial injuries that were life threatening with widespread fractures, marked disruption of facial structures, a cerebrospinal fluid fistula requiring bifrontal surgical repair, and loss of one eye. In a separate accident with a different potato gun, a 14-year-old boy who was wearing glasses at the time of injury had a sight-threatening perforating corneal laceration. CONCLUSION: Practitioners must be aware of the existence of these new, homemade unregulated devices. Information about the use and construction of these guns is widespread on the Internet, but no injuries resulting from these guns currently are documented in the medical literature.     

The predictors of quality care

Patients' perceptions of quality are important to the performance ratings, financial viability, and operational options afforded to purchasers of health care. Through TRICARE, the Department of Defense provides care for the more than 1.5 million active duty service members charged with the defense of the nation. As patients, these service members are typically incapable of assessing the technical quality of the care they receive. This study examines the attributes of health care delivery that define military patients' perceptions of quality and discusses the implications of these assessments.