The Louisiana State University (LSU) Eye Center, a participant in the current Herpetic Eye Disease Study (HEDS), proposes to be a Regional Center for Phase II of the Herpetic Eye Disease Study. Phase II will consist of two randomized, double-masked clinical trials and a non-experimental study of recurrence factors of ocular herpetic disease. The first trial, Herpetic Eye Disease Study - Epithelial Keratitis Trial (HEDS-EKT), will compare oral acyclovir to placebo for the prevention or delay of subsequent stromal keratitis or iritis in patients with active herpetic epithelial keratitis. The second trial, Herpetic Eye Disease Study - Acyclovir Prevention Trial (HEDS-APT) will compare oral acyclovir to placebo for prolonging time to recurrence of herpetic eye disease in patients with an episode of any herpetic eye disease in the past year who have been free of disease and off all treatment for the past month. The Recurrence Factors Study will obtain data by questionnaire on stress, trauma, and other potential recurrence factors of herpetic disease for correlation with recurrence data from the two clinical trials. As a Regional Center, the LSU Eye Center will be responsible for entering patients in the two clinical trails, and treating and following them according to protocol; entering randomized patients into the Recurrence Factors Study; coordinating and overseeing the participation of eight additional Participating Sites in the EKT and APT trials; and participating in the governance of HEDS via participation on the Executive Committee.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY009686-03
Application #
2163366
Study Section
Vision Research and Training Committee (VSN)
Project Start
1992-08-01
Project End
1997-07-31
Budget Start
1994-08-01
Budget End
1995-07-31
Support Year
3
Fiscal Year
1994
Total Cost
Indirect Cost
Name
Louisiana State University Hsc New Orleans
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
782627814
City
New Orleans
State
LA
Country
United States
Zip Code
70112