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

doi:10.1016/s1542-0124(12)70084-8

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 journal › Article › peer-review

53 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 language	English
Pages (from-to)	153-162
Number of pages	10
Journal	Ocular Surface
Volume	5
Issue number	2
DOIs	https://doi.org/10.1016/s1542-0124(12)70084-8
Publication status	Published - 2007 Apr
Externally published	Yes

Keywords

Clinical trials
DEWS
Dry Eye WorkShop
Dry eye

ASJC Scopus subject areas

Ophthalmology

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10.1016/s1542-0124(12)70084-8

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AU - Schein, Oliver

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

Abstract

Keywords

ASJC Scopus subject areas

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