Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000138
Status:
UNKNOWN
Last Update Posted:
2009-09-17
First Post:
1999-09-23
Brief Title:
Herpetic Eye Disease Study HEDS I
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2009-09
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 450000 people in the United States can develop recurrent episodes of the disease and about 46000 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 18 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
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 18 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None