Herpetic Eye Disease Study (HEDS) II

NCT00000139 | Completed Phase 3

• 1 other identifier: NEI-38
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief Summary

To determine whether early treatment (with oral acyclovir) of herpes simplex virus (HSV) ulcerations of the corneal epithelium prevents progression to the blinding complications of stromal keratitis and iridocyclitis. To determine the efficacy of low-dose oral acyclovir in preventing recurrent HSV eye infection in patients with previous episodes of herpetic eye disease. To determine the role of external factors (such as ultraviolet light or corneal trauma) and behavioral factors (such as life stress) on the induction of ocular recurrences of HSV eye infections and disease.

Conditions

Keratitis, Herpetic; Ocular Herpes Simplex; Herpes Simplex

Keywords

Herpes Simplex Stromal Keratitis

Interventions

Stress BEHAVIORAL

Acyclovir DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Protocol-specific criteria are noted in the description above.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (8)

Francis I. Proctor Foundation, University of California, San Francisco

San Francisco, California, United States

Location

Emory Eye Center

Atlanta, Georgia, United States

Location

Eye Center, University of Illinois, Chicago

Chicago, Illinois, United States

Location

Louisiana State University Eye Center

New Orleans, Louisiana, United States

Location

Department of Ophthalmology, The Mount Sinai Medical Center

New York, New York, United States

Location

Wills Eye Hospital, Cornea Clinic

Philadelphia, Pennsylvania, United States

Location

Cullen Eye Institute, Baylor College of Medicine

Houston, Texas, United States

Location

The Eye Institute, Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Location

Related Publications (3)

• Dawson CR, Beck R, Wilhelmus KR, Cohen EJ. Herpetic eye disease study. You can help. Arch Ophthalmol. 1996 Jan;114(1):89-90. doi: 10.1001/archopht.1996.01100130085015. No abstract available.

  PMID: 8540857 BACKGROUND

• A controlled trial of oral acyclovir for the prevention of stromal keratitis or iritis in patients with herpes simplex virus epithelial keratitis. The Epithelial Keratitis Trial. The Herpetic Eye Disease Study Group. Arch Ophthalmol. 1997 Jun;115(6):703-12. doi: 10.1001/archopht.1997.01100150705001.

  PMID: 9194719 BACKGROUND

• Acyclovir for the prevention of recurrent herpes simplex virus eye disease. Herpetic Eye Disease Study Group. N Engl J Med. 1998 Jul 30;339(5):300-6. doi: 10.1056/NEJM199807303390503.

  PMID: 9696640 BACKGROUND

MeSH Terms

Conditions

Keratitis, Herpetic; Herpes Simplex

Interventions

Acyclovir

Condition Hierarchy (Ancestors)

Eye Infections, Viral; Eye Infections; Infections; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Keratitis; Corneal Diseases; Eye Diseases; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: October 1, 1992
• Last Updated: March 24, 2010

Record last verified: 2009-09

Locations

US (8)