MUTT II.

Trial name or title	Mycotic Ulcer Treatment Trial II (MUTT II)
Methods	Parallel group RCT
Participants	People aged 16 years or older with fungal corneal ulcer
Interventions	Topical voriconazole 1% combined with oral voriconazole compared to topical voriconazole 1% alone
Outcomes	Following text from entry on ClinicalTrials.gov: Primary Outcome Measures: Rate of perforation [ Time Frame: 3 months from enrollment ] [ Designated as safety issue: No ] Comparison of rate of perforation between the treatment groups (topical voriconazole with oral voriconazole vs. topical voriconazole with oral placebo) Secondary Outcome Measures: Best spectacle‐corrected logMAR visual acuity [ Time Frame: 3 weeks after enrollment ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] Number of adverse events [ Time Frame: At the time of adverse event ] [ Designated as safety issue: No ] Minimum inhibitory concentration of isolates [ Time Frame: 3 months after enrollment ] [ Designated as safety issue: No ] Microbiological cure at 7 days [ Time Frame: 7 days after enrollment ] [ Designated as safety issue: No ]
Starting date	May 2010. Estimated date of completion: August 2016
Contact information	Nisha Acharya, MD, MS nisha.acharya@ucsf.edu
Notes	http://clinicaltrials.gov/ct2/show/NCT00997035

N/A = not available; RCT = randomised controlled trial