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.