EFFICACY OF FORTIFIED FLUCONAZOLE EYE DROPS VS NATAMYCIN 5% IN TREATING FUNGAL KERATITIS

Abstract

Background: Fungal Keratistis is a serious corneal infection and a leading cause of visual impairment particularly in agricultural areas. Natamycin 5% has been the first-line topical antifungal medication but its limited stromal penetration and fungistatic mechanism have raised questions about its efficacy compared to fortified fluconazole, which has better water-soluble corneal penetration and broad antifungal activity.

Objectives: This study aims to compare the efficacy of both fortified fluconazole and natamycin 5% eye drops in the treatment of Fk measured by time to epithelial healing, corneal resolution, visual acuity improvement, ulcer size reduction including  hypopyon resolution.

Methodology: A double-blind Randomized Clinical Trial was conducted at Fazle Omar Hospital, Chenab Nagar, with 32 patients equally allocated into two groups of 16 using the chit method. Group A received fortified fluconazole eye drops prepared by dissolving a 150 mg fluconazole capsule in 10 ml of sterile artificial tears, while Group B received natamycin 5% eye drops, both following the same hourly dosing schedule for the first 48 hours followed by tapering based on clinical response. Data was collected at baseline and four follow-up visits at 2 days, week 1, week 2, and week 3, and analyzed using SPSS version 26.0 with Mann-Whitney U test applied for between-group comparisons at p < 0.05 significance level

Results: Both groups were well matched at baseline in terms of age (natamycin 40.56 ± 12.79 years, fluconazole 39.31 ± 12.21 years), gender, ulcer severity, ulcer depth, and ulcer location. Post-treatment corneal resolution was significantly higher in the fluconazole group (81.3%) compared to natamycin (25.0%, p = .000), with faster epithelial healing (6–9 days vs. 7–14 days, p = .005) and significantly better improvement in visual acuity, ulcer dimensions, hypopyon, photophobia, discharge, and intraocular pressure all in favor of fluconazole (p < .05).

Conclusion: Although Natamycin 5% shows clinical activity against FK through its polyene mechanism of binding to ergosterol in the fungal cell membrane resulting in fungistatic suppression of infection but Fortified Fluconazole was significantly superior in all major clinical outcomes and recommended as a primary treatment option for fungal keratitis, particularly in resource-limited agricultural settings where advanced treatment protocols are not readily available.