A New Long-acting Liposomal Topical Antifungal Formula: Human Clinical Study

Purpose: To study the clinical effect of a topical controlled-release ophthalmic fluconazole liposomal formulation on patients with Candida keratitis. Methods: Eleven eyes of 11 patients with Candida albicans corneal fungal infection (proved by cultures) were included in this study. All were treated with topical liposomal fluconazole (2 mg/mL) 3 times daily. The response to the treatment was divided into 3 categories: complete improvement, complete healing with scar formation at the end of 1 month; partial improvement, decrease in the ulcer size at the end of 1 month; and no improvement, includes extension of ulcer size and/or perforation that necessitates other approaches of management. The patients were examined daily over a 30-day period, and the results were recorded. Results: Eleven eyes with C. albicans as proved with laboratory cultures were included in this study (7 men and 4 women). Three of the patients included in this study had diabetes mellitus, and 2 patients had rheumatoid arthritis. Mean corneal ulcer diameter (mean of both horizontal and vertical diameters) was 5.5 mm (range, 3.5–6.5 mm). Mean duration of the ulcers at presentation was 7.6 days (range, 3–14 days). Eight patients improved after 1 month, whereas 1 patient had partial improvement and 2 patients did not improve and underwent amniotic membrane transplantation. One of the nonimproved patients progressed to perforation, and keratoplasty was performed. Mean decimal notation best-corrected visual acuity on presentation was 0.06, which was not improved at the end of the study. Conclusions: Therapy with topical liposomal fluconazole (2 mg/mL) carries a high success rate and fast effect in treating patients with C. albicans keratitis.