Topical 5% Natamycin With Oral Ketoconazole in Filamentous Fungal Keratitis: A Randomized Controlled Trial.

Abstract

To assess the role of additive oral antifungal therapy in deep keratitis caused by filamentous fungi. A randomized, masked, double-blind clinical trial. All patients presenting with culture-positive fungal keratitis with a size measuring 2 to 60 mm2 and involving more than 50% of stromal depth were enrolled in 1 of the 2 treatment arms. Group A received 5% natamycin, whereas Group B was given 200mg of oral ketoconazole twice a day in addition to 5% natamycin. Patients were followed up for 4 weeks. Liver function was assessed at baseline and at exit. Tests for significance included t test to compare the means of continuous variables, chi-square and Fisher's exact tests for comparing categorical variables and Kaplan-Meier procedure to estimate the survival rate. Of the 115 patients enrolled, 108 completed the study. Fifty-eight patients were in group A and 57 in group B. There was no significant difference in baseline characteristics or in ulcer characteristics between the 2 groups. In group A, 68.5% of the patients responded favorably to medical therapy, whereas in group B, 72.2% responded favorably. There was no statistically significant difference in healing between the 2 groups (P = -0.618). All patients had normal liver functions during the study. Although safe, oral ketoconazole did not add significant benefit to topical natamycin therapy in treating deep fungal keratitis. The efficacy of newer antifungal agents and drug delivery routes needs to be explored.