HERPETIC EYE DISEASE STUDY - A CONTROLLED TRIAL OF ORAL ACYCLOVIR FORHERPES-SIMPLEX STROMAL KERATITIS

Purpose: To evaluate the efficacy of oral acyclovir in treating stroma l keratitis caused by herpes simplex virus (HSV) in patients receiving concomitant topical corticosteroids and trifluridine. Methods: The au thors performed a randomized, double-masked, placebo-controlled, multi center trial in 104 patients with HSV stromal keratitis without accomp anying HSV epithelial keratitis. Sample size was chosen so that a 5%, one-tailed test would have an 80% chance of detecting a doubling of th e median time to treatment failure. Patients were randomized to receiv e 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 regime n of topical prednisolone phosphate and trifluridine. Ophthalmologic e xaminations 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 eve nt) was 84 days (95% confidence interval, 69-93 days) for the acyclovi r group and 62 days (95% confidence interval, 57-90 days) for the plac ebo group. By 16 weeks, 38 patients (75%) in the acyclovir group and 3 9 patients (74%) in the placebo group had failed treatment. Also by th at time, the keratitis had resolved with trial medications, and there was no subsequent worsening in nine patients (18%) in the acyclovir gr oup and ten (19%) in the placebo group. None of these results were sig nificantly different between the two groups. However, visual acuity im proved over 6 months in significantly more patients in the acyclovir g roup than in the placebo group. Conclusion: There was no statistically or clinically significant beneficial effect of oral acyclovir in trea ting HSV stromal keratitis in patients receiving concomitant topical c orticosteroids and trifluridine with regard to time to treatment failu re, proportion of patients who failed treatment, proportion of patient s whose keratitis resolved, time to resolution, or 6-month best-correc ted visual acuity. Visual acuity improved over 6 months in more patien ts in the acyclovir group than in the placebo group.