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Kirk Bateman, George W Ousler, Michael Watson, Keith Jeffrey Lane, Donna L Welch; A Mixed Model, Repeat Measure Analysis of Demographics and Dry Eye Signs and Symptoms in a Dry Eye Population. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4484.
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A multitude of risk factors influence the likelihood of developing dry eye signs and symptoms. A mixed model, repeat measure analysis determined the relative contribution of demographics to the severity of dry eye signs and symptoms in a large population of dry eye clinical trial participants.
Subjects who had successfully completed at least one dry eye study were included in this meta-analysis (n=1343). A mixed-model, repeat-measure analysis was performed to assess the contribution of age, gender, and duration of disease to the severity of clinician-graded baseline fluorescein staining and diary reported ocular discomfort and dryness (scored during a placebo run-in period). The results from the Type III F-test are reported.
Demographic criteria evaluated (age, gender, duration of disease) significantly affected sign and symptom severity (p<0.05). Increased age was associated with a worsening of signs (inferior, superior, central fluorescein staining) and a lessening of symptoms (ocular discomfort and dryness). Female gender was associated with both a worsening of clinical signs (inferior and central fluorescein staining) and a worsening of symptoms (ocular discomfort and dryness). Increased duration of disease was also associated with a worsening of both signs and symptoms of dry eye.
These findings demonstrate clear associations between demographics and dry eye sign and symptom severity. The finding of increased staining and decreased symptom levels in older patients is consistent with the literature, and may suggest the need to evaluate dry eye in the context of age. Increased severity of dry eye signs and symptoms in females is also consistent with previous findings. These demographic criteria should be carefully considered in clinical trial design.
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