NCT00557362|CompletedPhase 1/2Results
Therapeutic Exploratory Study of Comparing Natamycin and Voriconazole to Treat Fungal Corneal Ulcer
MUTT_TE
Mycotic Ulcer Treatment Trial Therapeutic Exploratory Study
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Sponsor study identifier
interventional
120
1 country
2
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
November 9, 2007
Actual (reported)November 14, 2007
Actual (reported)August 2008
Actual (reported)August 2008
Actual (reported)December 19, 2013
Actual (reported)Best Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model
The primary efficacy endpoint was BSCVA at 3 months in the study eye, using a linear regression model with 3-month BSCVA measured in logMAR (logarithm of the Minimum Angle of Resolution) as the outcome variable and treatment arm (voriconazole vs natamycin) and enrollment logMAR BSCVA and corneal de-epithelialization (yes or no) as covariates.
3 months from enrollment
Time to Resolution of Epithelial Defect
3 months from enrollment
Size of Infiltrate/Scar Post-treatment Was Analyzed in a Linear Regression Model Using Enrollment Infiltrate/Scar Size as a Covariate.
3 months from enrollment
Subgroup Analysis - Best Spectacle-corrected Visual Acuity Examined by Voriconazole and Natamycin Treatment Arms in Subgroups of Fungal Ulcers (Fusarium Spp and Aspergillus Spp).
3 months from enrollment
Best Hard Contact Lens-corrected Visual Acuity 3 Months After Enrollment in a Multiple Linear Regression Model With Enrollment Hard Contact Lens-corrected Visual Acuity as a Covariate
3 months from enrollment
Topical voriconazole with corneal de-epithelialization
Topical voriconazole without corneal de-epithelialization
Topical natamycin with corneal de-epithelialization
One drop of medication will be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake
Voriconazole (VFEND® I.V., Pfizer, New York, NY) will be prepared as a 1% solution. One drop of medication should be given every one hour while awake for one week. For another 2 weeks, one drop of medication should be given every 2 hours while awake
Aravind Eye Hospital
Madurai, Tamil Nadu, India
Aravind Eye Hospital
Pondicherry, Tamil Nadu, India
Prajna NV, Mascarenhas J, Krishnan T, Reddy PR, Prajna L, Srinivasan M, Vaitilingam CM, Hong KC, Lee SM, McLeod SD, Zegans ME, Porco TC, Lietman TM, Acharya NR. Comparison of natamycin and voriconazole for the treatment of fungal keratitis. Arch Ophthalmol. 2010 Jun;128(6):672-8. doi: 10.1001/archophthalmol.2010.102.
Thomas M Lietman, MD
Proctor Foundation, University of California, San Francisco
Nisha Acharya, MD MS
Proctor Foundation, University of California, San Francisco
N V Prajna, MD
Aravind Eye Hospital, India
120 participants (actual enrollment reported by the registry).
First Submitted
November 9, 2007
First Posted
November 14, 2007
Study Start
November 2007
Date type not reportedThis date has not been verified as actual or estimated.
Rose Bengal Electromagnetic Activation With Green Light for Infection Reduction
Topical natamycin without corneal de-epithelialization
Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.
Contact the study team to confirm eligibility.
Primary Completion
August 2008
Actual (reported)Study Completion
August 2008
Actual (reported)Last Updated
August 7, 2018
Results First Posted
December 19, 2013
Record last verified: 2018-07
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Source: ClinicalTrials.gov.
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