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Foundations of Corneal Disease pp 349–357Cite as

Clinical Trials in Dry Eye Disease: What We Have Learned and What We Still Need to Understand

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Abstract

Clinical trials in dry eye disease provide major challenges due to characteristics of the disease that require design parameters to control for variability in an unstable tear film and lack of correspondence between symptoms and signs of the disease. Lessons learned from previous randomized clinical trials are that precise selection of inclusion and exclusion criteria is essential for obtaining a positive outcome and that proper standardization of clinical procedures across multiple investigative sites is required. The relative lack of regulatory approval of pharmaceutical treatments for dry eye disease appears to be improving with better avoidance of the pitfalls of clinical trial design and an evolving regulatory environment, but ongoing challenges demand rigorous attention to detail in planning and execution of future prospective, randomized, vehicle-controlled, double-masked, parallel group clinical trials.

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Authors and Affiliations

  1. University of Louisville School of Medicine, Department of Ophthalmology and Vision Science, Wilmington, NC, USA

    Gary N. Foulks

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  1. Louis Block Professor Chair, Department of Ophthalmology and Visual Science, The University of Chicago Medicine & Biological Sciences, Chicago, IL, USA

    Kathryn Colby

  2. Claes H. Dohlman Professor of Ophthalmology, Harvard Medical School, Cornea & Refractive Surgery, Massachusetts Eye & Ear, Boston, MA, USA

    Reza Dana

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Foulks, G.N. (2020). Clinical Trials in Dry Eye Disease: What We Have Learned and What We Still Need to Understand. In: Colby, K., Dana, R. (eds) Foundations of Corneal Disease. Springer, Cham. https://doi.org/10.1007/978-3-030-25335-6_29

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