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George W Ousler, Michael Watson, Kirk Bateman, Keith Jeffrey Lane, Donna L Welch; Longitudinal Evaluation of Seasonal Differences in Patient-Reported Dry Eye Symptoms. Invest. Ophthalmol. Vis. Sci. 2015;56(7 ):4462.
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Dry eye syndrome has been reported to exhibit seasonal fluctuations, possibly due to increased evaporation in winter months. To date, no empirical studies have been performed to compare symptoms in and out of season within the same cohort of patients. We performed a meta-analysis of dry eye study data to evaluate seasonal differences in diary-reported symptoms.<br /> <br /> <br />  McCulley JP, Uchiyama E, Aronowicz JD, Butovich IA. Impact of evaporation on aqueous tear loss.<br /> Trans Am Ophthalmol Soc. 2006;104:121-8.
Diary-reported symptom scores from 10 clinical trials in dry eye, completed over a 6-year period, were compiled in a longitudinal database. Data were selected from subjects treated with placebo in pre-trial run-in periods for the purposes of study eligibility. A subset of 270 subjects who had participated in at least one summer season study (April-September enrollment) and one winter season study (October-March enrollment) were identified and included in the analysis. Differences in diary-recorded ocular discomfort and dryness symptoms (graded using the Ora CalibraTM 4-Symptom Scale) were compared between winter and summer seasons to identify any seasonal differences in symptom severity.
There was a significant seasonal difference observed for diary-reported ocular discomfort symptoms (summer - winter, -0.119 ± 0.916 (p=0.034), with patients experiencing higher levels of symptoms during the winter season. Patients also reported higher dryness levels during the winter season, although this difference did not reach statistical significance (p=0.140).
Seasonal differences in patient-reported symptoms were observed in this analysis, with elevated ocular discomfort reported during the winter season. In the context of clinical trials, seasonal variations in symptoms may be a confounding factor, and best efforts should be made to complete trials within a given season to minimize this variability.
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