June 2015
Volume 56, Issue 7
Free
ARVO Annual Meeting Abstract  |   June 2015
Longitudinal Evaluation of Seasonal Differences in Patient-Reported Dry Eye Symptoms
Author Affiliations & Notes
  • George W Ousler
    Dry Eye, Ora, Inc., Andover, MA
  • Michael Watson
    Dry Eye, Ora, Inc., Andover, MA
  • Kirk Bateman
    Director, Statistics and Data Corporation, Tempe, AZ
  • Keith Jeffrey Lane
    R & D, Ora, Inc., Andover, MA
  • Donna L Welch
    Ora, Inc., Andover, MA
  • Footnotes
    Commercial Relationships George Ousler, Ora, Inc. (E); Michael Watson, Ora, Inc. (E); Kirk Bateman, SDC, Inc. (E); Keith Lane, Ora, Inc. (E); Donna Welch, Ora, Inc. (E)
  • Footnotes
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Investigative Ophthalmology & Visual Science June 2015, Vol.56, 4462. doi:
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    • Get Citation

      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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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose: Dry eye syndrome has been reported to exhibit seasonal fluctuations, possibly due to increased evaporation in winter months.[1] 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 /> [1] McCulley JP, Uchiyama E, Aronowicz JD, Butovich IA. Impact of evaporation on aqueous tear loss.<br /> Trans Am Ophthalmol Soc. 2006;104:121-8.

Methods: 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.

Results: 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).

Conclusions: 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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