Clinical Trial: Mycotic Ulcer Treatment Trial II

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Mycotic Ulcer Treatment Trial

Brief Summary: The purpose of this study is to determine if the addition of oral voriconazole to topical treatment regimens results in lower rates of perforation in severe fungal corneal ulcers.

Detailed Summary:

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 of oral voriconazole in severe ulcers reduces the rate of perforations. 240 fungal corneal ulcers with baseline visual acuity worse than 6/120 presenting to the Aravind Eye Hospitals and the UCSF Proctor Foundation will be randomized to receive oral voriconazole plus topical voriconazole and topical natamycin, or oral placebo plus topical voriconazole and topical natamycin. The primary outcome is the rate of perforation over the three month follow-up period.


Sponsor: University of California, San Francisco

Current Primary Outcome: Rate of perforation [ Time Frame: 3 months from enrollment ]

Comparison of rate of perforation between the treatment groups (topical voriconazole with oral voriconazole vs. topical voriconazole with oral placebo)


Original Primary Outcome: Comparison of rate of perforation between the treatment groups (topical voriconazole with oral voriconazole vs. topical voriconazole with oral placebo) [ Time Frame: 3 months from enrollment ]

Current Secondary Outcome:

  • Best spectacle-corrected logMAR visual acuity [ Time Frame: 3 weeks after enrollment ]
    Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear
  • Best spectacle-corrected logMAR visual acuity only in Indian sites [ Time Frame: 3 weeks and 3 months after enrollment ]
    Best spectacle-corrected logMAR visual acuity only in Indian sites, 3 weeks and 3 months after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear regression model
  • Best spectacle-corrected logMAR visual acuity [ Time Frame: 3 months after enrollment ]
    Best spectacle-corrected logMAR visual acuity 3 months after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear
  • Hard contact-lens corrected visual acuity measured in logMAR [ Time Frame: 3 months after enrollment ]
    Hard contact-lens corrected visual acuity measured in logMAR 3 months after enrollment
  • Size of infiltrate/scar [ Time Frame: 3 weeks and 3 months after enrollment ]
    Size of infiltrate/scar at 3 weeks and 3 months after enrollment, using enrollment infiltrate scar/size as a covariate
  • Time to resolution of epithelial defect [ Time Frame: At the time of resolution of epithelial defect ]
  • Number of adverse events [ Time Frame: At the time of adverse event ]
  • Minimum inhibitory concentration of isolates [ Time Frame: 3 months after enrollment ]
  • Microbiological cure at 7 days [ Time Frame: 7 days after enrollment ]


Original Secondary Outcome:

  • Best spectacle-corrected logMAR visual acuity at 3 weeks after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear regression model [ Time Frame: 3 weeks after enrollment ]
  • Best spectacle-corrected logMAR visual acuity only in Indian sites, 3 weeks and 3 months after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear regression model [ Time Frame: 3 weeks and 3 months after enrollment ]
  • Best spectacle-corrected logMAR visual acuity 3 months after enrollment, adjusting for enrollment BSCVA and treatment arm in a multiple linear regression model [ Time Frame: 3 months after enrollment ]
  • Hard contact-lens corrected visual acuity measured in logMAR 3 weeks and 3 months after enrollment [ Time Frame: 3 weeks and 3 months after enrollment ]
  • Size of infiltrate/scar at 3 weeks and 3 months after enrollment, using enrollment infiltrate scar/size as a covariate [ Time Frame: 3 weeks and 3 months after enrollment ]
  • Time to resolution of epithelial defect [ Time Frame: At the time of resolution of epithelial defect ]
  • Number of adverse events [ Time Frame: At the time of adverse event ]
  • Minimum inhibitory concentration of isolates [ Time Frame: 3 months after enrollment ]
  • Microbiological cure at 7 days [ Time Frame: 7 days after enrollment ]


Information By: University of California, San Francisco

Dates:
Date Received: October 14, 2009
Date Started: May 2010
Date Completion: June 2016
Last Updated: June 7, 2016
Last Verified: June 2016