Sample Size and Power Tabulations in Dry Eye Clinical Trials

Jul 11, 2018 | Publications and Posters

ARVO Annual Meeting, May 2012


Sample size and power estimation are essential aspects of clinical trial design. The techniques used to generate these estimates often involve complex statistical calculations and statistical software. Clinical personnel do not necessarily have strong backgrounds in or knowledge about statistics, nor do statisticians always have full clinical backgrounds or knowledge, however it generally requires both clinical and statistical inputs to plan a successful and meaningful trial. The sample size and power tabulations here were developed as a tool to use during protocol development or clinical trial planning. Their use does not require intensive statistical theory and they are easy to use. Using the classic dry eye assessments of corneal staining and ocular discomfort, we have developed tabulations of sample size and power for endpoints with mean difference (MD) ranges from 0.1 to 1 unit and standard deviation (SD) ranges from 0.5 to 1.5 units.

This poster details:

  • A general method for calculating power and sample size for dry eye clinical trials
  • The approach taken to develop this model based on mean difference and standard deviation
  • Applications for other therapeutic areas

Authored by:

  • Nuttha Lurponglukana-Strand, PhD
  • Dale Usner, PhD
  • Kathryn Kennedy, PhD
  • Dale Kennedy, PhD
  • Richard Abelson, PhD

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