Corneal Ulcer Clinical Trial
Official title:
Mycotic Ulcer Treatment Trial
The purpose of this study is to determine if natamycin or voriconazole results in better visual outcomes in fungal corneal ulcers, especially visual acuity.
Fungal corneal ulcers tend to have very poor outcomes with commonly used treatments. There
has only been a single randomized trial of anti-fungal therapy for mycotic keratitis, and no
new ocular anti-fungal medications have been approved by the FDA since the 1960s. The
triazole voriconazole has recently become the treatment of choice for systemic fungal
infections such as pulmonary aspergillosis. The use of topical ophthalmic preparations of
voriconazole has been described in numerous case reports, however there has been no
systematic attempt to determine whether it is more or less clinically effective than
natamycin. Additionally, there have been many case reports of the use of oral voriconazole in
the treatment of fungal corneal ulcers, however there has been no systematic attempt to
determine if it improves outcomes in severe ulcers.
This study is a randomized, double-masked, placebo-controlled trial to determine if the use
natamycin or voriconazole results in better outcomes for fungal corneal ulcers. 368 fungal
corneal ulcers with baseline visual acuity between 6/12 (20/40, logMAR 0.3) and 6/120
(20/400, logMAR 1.3) presenting to the Aravind Eye Hospitals and the UCSF Proctor Foundation
will be randomized to receive either topical natamycin or topical voriconazole. The primary
outcome is best spectacle-corrected logMAR visual acuity three months after enrollment, using
best spectacle-corrected enrollment visual acuity as a co-variate.
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