Fungal Keratitis Clinical Trial
Official title:
Mycotic Ulcer Treatment Trial Therapeutic Exploratory Study
We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data.
Fungal ulcers tend to have very poor outcomes with the most common treatments, amphotericin B
and natamycin. There has been only a single randomized trial of anti-fungal therapy for
fungal ulcers and no new medications have been approved by the FDA since the 1960s. There are
studies that indicate that the newer triazoles, such as voriconazole, are more effective in
vitro against filamentous fungi such as Aspergillus spp., a common cause of fungal
keratitis1-3. Despite a number of case reports and in vitro studies, there has been no
systematic attempt to determine whether it is more or less effective clinically than
natamycin, the only commercially available FDA-approved agent. There is little data available
for physicians to make an informed, evidence-based decision on choice of antifungal.
We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal
keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study
to investigate the safety and feasibility of conducting a larger study and to generate
preliminary data. The primary outcome is visual acuity at 3 months from enrollment. A subset
of patients will be followed at 4 years from enrollment.
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