TY - JOUR
T1 - Herpetic Eye Disease Study
T2 - A Controlled Trial of Oral Acyclovir for Herpes Simplex Stromal Keratitis
AU - Dawson, Chandler R.
AU - Margolis, Todd P.
AU - Nozik, Robert A.
AU - Ostler, H. Bruce
AU - Kurinij, Natalie
AU - Dawson, Chandler R.
AU - Gee, Lauren
AU - Hauck, Walter W.
AU - Hidayat, Jon E.
AU - Kurinij, Natalie
N1 - Funding Information:
Originally received: June 21,1993. Revision accepted: June 17, 1994. * Members of the Herpetic Eye Disease Study are listed in the Appendix at the end of this article. Presented in part at the American Academy of Ophthalmology Annual Meeting, Dallas, November 1992. Supported in part by cooperative agreements (EY07479, EY07480, EY07482, EY07483, EY07486, EY07487, EY07488, EY07489, and EY07496) with the National Eye Institute, National Institutes of Health, and the United States Department of Health and Human Services, Bethesda, Maryland. IOLAB Corporation and Burroughs Well come Co. supplied the study medications. The authors have no proprietary interest in any of the drugs or devices used in this study. Reprint requests to Chandler R. Dawson, MD, Francis I. Proctor Foundation, University of Califomia, San Francisco, San Francisco, CA 94143-0412.
PY - 1994
Y1 - 1994
N2 - Purpose: To evaluate the efficacy of oral acyclovir in treating stromal keratitis caused by herpes simplex virus (HSV) in patients receiving concomitant topical corticosteroids and trifluridine. Methods: The authors performed a randomized, double-masked, placebo-controlled, multicenter trial in 104 patients with HSV stromal keratitis without accompanying HSV epithelial keratitis. Sample size was chosen so that a 5%, one-tailed test would have an 80% chance of detecting a doubling of the median time to treatment failure. Patients were randomized to receive a 10-week course of either oral acyclovir (400 mg 5 times daily, n = 51) or placebo (n = 53). All patients also received a standard regimen of topical prednisolone phosphate and trifluridine. Ophthalmologic examinations were performed weekly during the 10-week treatment period, every 2 weeks for an additional 6 weeks, and at 6 months after entry into the trial. Results: The median time to treatment failure (defined as worsening or no improvement of stromal keratitis or an adverse event) was 84 days (95% confidence interval, 69-93 days) for the acyclovir group and 62 days (95% confidence interval, 57-90 days) for the placebo group. By 16 weeks, 38 patients (75%) in the acyclovir group and 39 patients (74%) in the placebo group had failed treatment. Also by that time, the keratitis had resolved with trial medications, and there was no subsequent worsening in nine patients (18%) in the acyclovir group and ten (19%) in the placebo group. None of these results were significantly different between the two groups. However, visual acuity improved over 6 months in significantly more patients in the acyclovir group than in the placebo group. Conclusion: There was no statistically or clinically significant beneficial effect of oral acyclovir in treating HSV stromal keratitis in patients receiving concomitant topical corticosteroids and trifluridine with regard to time to treatment failure, proportion of patients who failed treatment, proportion of patients whose keratitis resolved, time to resolution, or 6-month best-corrected visual acuity. Visual acuity improved over 6 months in more patients in the acyclovir group than in the placebo group.
AB - Purpose: To evaluate the efficacy of oral acyclovir in treating stromal keratitis caused by herpes simplex virus (HSV) in patients receiving concomitant topical corticosteroids and trifluridine. Methods: The authors performed a randomized, double-masked, placebo-controlled, multicenter trial in 104 patients with HSV stromal keratitis without accompanying HSV epithelial keratitis. Sample size was chosen so that a 5%, one-tailed test would have an 80% chance of detecting a doubling of the median time to treatment failure. Patients were randomized to receive a 10-week course of either oral acyclovir (400 mg 5 times daily, n = 51) or placebo (n = 53). All patients also received a standard regimen of topical prednisolone phosphate and trifluridine. Ophthalmologic examinations were performed weekly during the 10-week treatment period, every 2 weeks for an additional 6 weeks, and at 6 months after entry into the trial. Results: The median time to treatment failure (defined as worsening or no improvement of stromal keratitis or an adverse event) was 84 days (95% confidence interval, 69-93 days) for the acyclovir group and 62 days (95% confidence interval, 57-90 days) for the placebo group. By 16 weeks, 38 patients (75%) in the acyclovir group and 39 patients (74%) in the placebo group had failed treatment. Also by that time, the keratitis had resolved with trial medications, and there was no subsequent worsening in nine patients (18%) in the acyclovir group and ten (19%) in the placebo group. None of these results were significantly different between the two groups. However, visual acuity improved over 6 months in significantly more patients in the acyclovir group than in the placebo group. Conclusion: There was no statistically or clinically significant beneficial effect of oral acyclovir in treating HSV stromal keratitis in patients receiving concomitant topical corticosteroids and trifluridine with regard to time to treatment failure, proportion of patients who failed treatment, proportion of patients whose keratitis resolved, time to resolution, or 6-month best-corrected visual acuity. Visual acuity improved over 6 months in more patients in the acyclovir group than in the placebo group.
UR - http://www.scopus.com/inward/record.url?scp=0028559731&partnerID=8YFLogxK
U2 - 10.1016/S0161-6420(13)31155-5
DO - 10.1016/S0161-6420(13)31155-5
M3 - Article
C2 - 7997323
AN - SCOPUS:0028559731
SN - 0161-6420
VL - 101
SP - 1871
EP - 1882
JO - Ophthalmology
JF - Ophthalmology
IS - 12
ER -