Design and organization of the herpetic eye disease study (HEDS).
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.
Dawson
C R
CR
Francis I. Proctor Foundation, University of California, San Francisco.
Jones
D B
DB
Kaufman
H E
HE
Barron
B A
BA
Hauck
W W
WW
Wilhelmus
K R
KR
D000212:Acyclovir / Q000627:therapeutic use*; D000284:Administration, Oral; D000287:Administration, Topical; D002985:Clinical Protocols; D003319:Corneal Stroma / Q000187:drug effects; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D006801:Humans; D015863:Iridocyclitis / Q000188:drug therapy*; D007635:Keratitis, Dendritic / Q000188:drug therapy*; D010919:Placebos; D011239:Prednisolone / Q000627:therapeutic use*; D011379:Prognosis; D012107:Research Design
D010919:Placebos; D011239:Prednisolone; D000212:Acyclovir