Design and conduct of clinical trials: Report of the clinical trials subcommittee of the international Dry Eye WorkShop (2007)

Kazuo Tsubota, Penny Ashell, Murat Dogru, Desmond Fonn, Gary Foulks, Debra Schaumberg, Oliver Schein, Hitoshi Watanabe

Research output: Contribution to journalArticle

44 Citations (Scopus)

Abstract

This report summarizes some universal concepts with regard to clinical trials in general and other issues pertaining to clinical trials specifically tailored to the study of therapeutic intervention in dry eye disease. The report also makes recommendations for logistical design and implementation of such trials. It identifies peculiarities of dry eye disease that complicate clinical trial design, such as the lack of correlation of signs and symptoms, as well as the likelihood of control interventions having a lubricant (placebo) effect. Strategies for environmental trials and controlled adverse environment trials are reviewed.

Original languageEnglish
Pages (from-to)153-162
Number of pages10
JournalOcular Surface
Volume5
Issue number2
DOIs
Publication statusPublished - 2007 Apr

Keywords

  • Clinical trials
  • DEWS
  • Dry Eye WorkShop
  • Dry eye

ASJC Scopus subject areas

  • Ophthalmology

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