TFOS DEWS II Clinical Trial Design Report

Gary D. Novack, Penny Asbell, Stefano Barabino, Michael V.W. Bergamini, Joseph B. Ciolino, Gary N. Foulks, Michael Goldstein, Michael A. Lemp, Stefan Schrader, Craig Woods, Fiona Stapleton

Research output: Contribution to journalReview article

16 Citations (Scopus)

Abstract

The development of novel therapies for Dry Eye Disease (DED) is formidable, and relatively few treatments evaluated have been approved for marketing. In this report, the Subcommittee reviewed challenges in designing and conducting quality trials, with special reference to issues in trials in patients with DED and present the regulatory perspective on DED therapies. The Subcommittee reviewed the literature and while there are some observations about the possible reasons why so many trials have failed, there is no obvious single reason other than the lack of correlation between signs and symptoms in DED. Therefore the report advocates for conducting good quality studies, as described, going forward. A key recommendation for future studies is conduct consistent with Good Clinical Practice (GCP), including use of Good Manufacturing Practice (GMP) quality clinical trial material. The report also recommends that the design, treatments, and sample size be consistent with the investigational treatment, the objectives of the study, and the phase of development. Other recommendations for pivotal studies are a priori selection of the outcome measure, and an appropriate sample size.

Original languageEnglish (US)
Pages (from-to)629-649
Number of pages21
JournalOcular Surface
Volume15
Issue number3
DOIs
StatePublished - Jul 1 2017

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Eye Diseases
Clinical Trials
Sample Size
Investigational Therapies
Therapeutics
Marketing
Signs and Symptoms
Outcome Assessment (Health Care)

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Cite this

Novack, G. D., Asbell, P., Barabino, S., Bergamini, M. V. W., Ciolino, J. B., Foulks, G. N., ... Stapleton, F. (2017). TFOS DEWS II Clinical Trial Design Report. Ocular Surface, 15(3), 629-649. https://doi.org/10.1016/j.jtos.2017.05.009

TFOS DEWS II Clinical Trial Design Report. / Novack, Gary D.; Asbell, Penny; Barabino, Stefano; Bergamini, Michael V.W.; Ciolino, Joseph B.; Foulks, Gary N.; Goldstein, Michael; Lemp, Michael A.; Schrader, Stefan; Woods, Craig; Stapleton, Fiona.

In: Ocular Surface, Vol. 15, No. 3, 01.07.2017, p. 629-649.

Research output: Contribution to journalReview article

Novack, GD, Asbell, P, Barabino, S, Bergamini, MVW, Ciolino, JB, Foulks, GN, Goldstein, M, Lemp, MA, Schrader, S, Woods, C & Stapleton, F 2017, 'TFOS DEWS II Clinical Trial Design Report', Ocular Surface, vol. 15, no. 3, pp. 629-649. https://doi.org/10.1016/j.jtos.2017.05.009
Novack GD, Asbell P, Barabino S, Bergamini MVW, Ciolino JB, Foulks GN et al. TFOS DEWS II Clinical Trial Design Report. Ocular Surface. 2017 Jul 1;15(3):629-649. https://doi.org/10.1016/j.jtos.2017.05.009
Novack, Gary D. ; Asbell, Penny ; Barabino, Stefano ; Bergamini, Michael V.W. ; Ciolino, Joseph B. ; Foulks, Gary N. ; Goldstein, Michael ; Lemp, Michael A. ; Schrader, Stefan ; Woods, Craig ; Stapleton, Fiona. / TFOS DEWS II Clinical Trial Design Report. In: Ocular Surface. 2017 ; Vol. 15, No. 3. pp. 629-649.
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