Design and organization of the herpetic eye disease study (HEDS)

C. R. Dawson Francis I.Proctor Foundation, University of California, San Francisco

D. B. Jones Cullen Eye Institute, Baylor College of Medicine, Houston

H. E. Kaufman LSU Eye Center, Louisiana State University, New Orleans

B. A. Barron LSU Eye Center, Louisiana State University, New Orleans

W. W. Hauck Francis I.Proctor Foundation, University of California, San Francisco; Department of Epidemiology and Biostatistics, University of California, San Francisco, USA

K. R. Wilhelmus Cullen Eye Institute, Baylor College of Medicine, Houston

Abstract

The Herpetic Eye Disease Study (HEDS) includes three double-masked, placebo-controlled clinical trials for potentially blinding herpes simplex virus (HSV) eye infections. One study compares a tapering dosage of topical prednisolone or placebo eye drops for HSV stromal keratitis (HEDS-SKN). Two other trials compare oral acyclovir to placebo capsules for HSV stromal keratitis (HEDS-SKS) or iridocyclitis (HEDS-IRT) in patients on a tapering dosage of topical prednisolone drops. All medications are administered for 10 weeks. Outcome is judged by time to recurrent disease or treatment failure. This paper presents the design, estimated sample size and recruitment as of July 25, 1990.

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Design and organization of the herpetic eye disease study (HEDS)

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Design and organization of the herpetic eye disease study (HEDS)

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