Herpetic Eye Disease Study (HEDS) I
Information source: National Eye Institute (NEI)
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Keratitis, Herpetic; Ocular Herpes Simplex
Intervention: Prednisolone Phosphate (Drug); Acyclovir (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: National Eye Institute (NEI)
Summary
To evaluate the efficacy of topical corticosteroids in treating herpes simplex stromal
keratitis in conjunction with topical trifluridine.
To evaluate the efficacy of oral acyclovir in treating herpes simplex stromal keratitis in
patients receiving concomitant topical corticosteroids and trifluridine.
To evaluate the efficacy of oral acyclovir in treating herpes simplex iridocyclitis in
conjunction with treatment with topical corticosteroids and trifluridine.
Clinical Details
Study design: Allocation: Randomized, Primary Purpose: Treatment
Detailed description:
Herpes simplex keratitis is a leading cause of corneal opacification in the United States,
other industrialized countries, and developing nations throughout the world. An estimated
450,000 people in the United States can develop recurrent episodes of the disease and about
46,000 episodes of HSV eye infection every year. Herpetic eye disease is the most common
infectious cause of corneal blindness in this country.
Despite the availability of antiviral agents that are effective in treating herpes simplex
epithelial keratitis, inflammation in the corneal connective tissue and iris that can lead
to corneal scarring and visual impairment develops in many patients. Prior to the HEDS-I
trials, the role of topical corticosteroids in the management of HSV stromal keratitis was
uncertain; some animal and human studies suggested there was a benefit to treatment whereas
others suggested harm. The value of adding an oral antiviral agent to treatment with topical
corticosteroids and topical antivirals also was unknown.
The HEDS-I trials were developed to assess the efficacy of topical corticosteroids and oral
acyclovir in treating HSV stromal keratitis and iridocyclitis.
HEDS-I consisted of three randomized, placebo-controlled trials. The organizational
structure consisted of a data coordinating center and eight clinical centers.
All patients received the topical antiviral trifluridine as prophylaxis against recurrences
of HSV epithelial ulceration. Patients were evaluated weekly for 10 weeks, every other week
through week 16, and again at 6 months. The primary outcome was the time to development of
preset criteria for treatment failure during the 16-week period of examination.
Protocol-specific descriptions of the three trials follow.
Herpes Stromal Keratitis, Not on Steroid Trial (HEDS-SKN): Patients with active HSV stromal
keratitis who had not used a topical corticosteroid in the preceding 10 days were randomized
to treatment with topical prednisolone phosphate drops or topical placebo drops. A
treatment schedule, starting with 8 drops a day of 1 percent prednisolone phosphate for 7
days, was progressively decreased over 10 weeks in such a way that patients received 1 drop
per day of 1/8 percent prednisolone for the last 3 weeks of treatment. Placebo drops were
given by the same schedule.
Herpes Stromal Keratitis, on Steroid Treatment (HEDS-SKS): Patients with active HSV stromal
keratitis who already were being treated with a topical corticosteroid were randomized
either to oral treatment with 200 mg acyclovir capsules (400 mg five times daily) for 10
weeks or to the identical dose of placebo capsules. Patients also received topical
prednisolone phosphate in the dosage schedule described above for the SKN trial.
Herpes Simplex Virus Iridocyclitis, Receiving Topical Steroids (HEDS-IRT): Patients with
active HSV iridocyclitis were randomized either to oral treatment with 200 mg acyclovir
capsules (400 mg five times daily) for 10 weeks or to the identical dose of placebo
capsules. Patients also received topical prednisolone phosphate in the dosage schedule
described above for the SKN trial.
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Eligibility criteria common to the three protocols included age 12 years or older, no
active HSV epithelial keratitis, no prior keratoplasty of the involved eye, and not
pregnant. Protocol-specific criteria are noted in the description above.
Locations and Contacts
Additional Information
Herpetic Eye Disease Study (HEDS) II
Related publications: Dawson CR. The herpetic Eye Disease Study. Arch Ophthalmol. 1990 Feb;108(2):191-2. Dawson CR; Jones DB; Kaufman HE; Barron BA; Hauck WW; Wilhelmus KR; The Herpetic Eye Disease Study: Strategies of design and data analysis [Abstract]., Invest Ophthalmol Vis Sci 1990;31:553 Dawson CR, Jones DB, Kaufman HE, Barron BA, Hauck WW, Wilhelmus KR. Design and organization of the herpetic eye disease study (HEDS). Curr Eye Res. 1991;10 Suppl:105-10. Dawson CR; Jones DB; Wilhelmus KR; Kaufman HE; Barron BA; Hauck WW; Evaluation of corneal inflammatory disease: The Herpetic Eye Disease Study (HEDS) [Abstract]., Invest Ophthalmol Vis Sci 1991;32:1221 Dawson CR; Hauck WW; Jones DB; Kaufman HE; Gee L; Barron BA; Wilhelmus KR; The Herpetic Eye Disease Study (HEDS). Clinical characteristics of randomized patients with herpetic stromal keratitis and iridocyclitis prior to initiating treatment [Abstract]., Invest Ophthalmol Vis 1992;33:1134 Barron BA, Gee L, Hauck WW, Kurinij N, Dawson CR, Jones DB, Wilhelmus KR, Kaufman HE, Sugar J, Hyndiuk RA, et al. Herpetic Eye Disease Study. A controlled trial of oral acyclovir for herpes simplex stromal keratitis. Ophthalmology. 1994 Dec;101(12):1871-82. Wilhelmus KR, Gee L, Hauck WW, Kurinij N, Dawson CR, Jones DB, Barron BA, Kaufman HE, Sugar J, Hyndiuk RA, et al. Herpetic Eye Disease Study. A controlled trial of topical corticosteroids for herpes simplex stromal keratitis. Ophthalmology. 1994 Dec;101(12):1883-95; discussion 1895-6. A controlled trial of oral acyclovir for iridocyclitis caused by herpes simplex virus. The Herpetic Eye Disease Study Group. Arch Ophthalmol. 1996 Sep;114(9):1065-72. Wilhelmus KR, Dawson CR, Barron BA, Bacchetti P, Gee L, Jones DB, Kaufman HE, Sugar J, Hyndiuk RA, Laibson PR, Stulting RD, Asbell PA. Risk factors for herpes simplex virus epithelial keratitis recurring during treatment of stromal keratitis or iridocyclitis. Herpetic Eye Disease Study Group. Br J Ophthalmol. 1996 Nov;80(11):969-72.
Starting date: May 1989
Last updated: September 16, 2009
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