Mycotic Ulcer Treatment Trial I (MUTT I)

This study has been completed.
Sponsor:
Collaborators:
Aravind Eye Hospitals, India
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
Thomas M. Lietman, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00996736
First received: October 14, 2009
Last updated: October 18, 2013
Last verified: October 2013
Results First Received: July 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Corneal Ulcer
Eye Infections, Fungal
Interventions: Drug: Natamycin
Drug: Voriconazole

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between April 3, 2010, and December 31, 2011, patients were recruited from the Cornea Clinics at the Aravind Eye Care Hospitals in Madurai, Pondicherry, and Coimbatore in Tamil Nadu, India.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Topical Natamycin No text entered.
Topical Voriconazole No text entered.

Participant Flow:   Overall Study
    Topical Natamycin     Topical Voriconazole  
STARTED     162     161  
3-week Visit     155 [1]   151 [2]
3-month Visit     146     146  
COMPLETED     141     143  
NOT COMPLETED     21     18  
Death                 1                 1  
Lost to Follow-up                 15                 14  
Visit not within 3-month window                 5                 3  
[1] 149 visited within pre-specified 3-week window (2.5-5 weeks); 6 had a second visit not within window
[2] 144 visited within pre-specified 3-week window (2.5-5 weeks); 7 had a second visit not within window



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Topical Natamycin No text entered.
Topical Voriconazole No text entered.
Total Total of all reporting groups

Baseline Measures
    Topical Natamycin     Topical Voriconazole     Total  
Number of Participants  
[units: participants]
  162     161     323  
Age  
[units: years]
Median ( Inter-Quartile Range )
  48  
  ( 39 to 58 )  
  45  
  ( 38 to 55 )  
  47  
  ( 39 to 56 )  
Gender  
[units: participants]
     
Female     73     67     140  
Male     89     94     183  
Region of Enrollment  
[units: participants]
     
India     162     161     323  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Best Spectacle-corrected logMAR Visual Acuity   [ Time Frame: 3 months from enrollment ]

2.  Secondary:   Best Spectacle-corrected logMAR Visual Acuity   [ Time Frame: 3 weeks after enrollment ]

3.  Secondary:   Hard Contact Lens-corrected Visual Acuity Measured in logMAR   [ Time Frame: 3 months after enrollment ]

4.  Secondary:   Size of Infiltrate/Scar   [ Time Frame: 3 weeks and 3 months after enrollment ]

5.  Secondary:   Time to Resolution of Epithelial Defect   [ Time Frame: From enrollment to the time of resolution of epithelial defect ]

6.  Secondary:   Minimum Inhibitory Concentration of Isolates   [ Time Frame: 3 months after enrollment ]

7.  Secondary:   Microbiological Cure at 6 Days   [ Time Frame: 7 days after enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Thomas Lietman
Organization: F.I. Proctor Foundation, University of Califonia, San Francisco
phone: 415-502-2662
e-mail: tom.lietman@ucsf.edu


No publications provided by University of California, San Francisco

Publications automatically indexed to this study:

Responsible Party: Thomas M. Lietman, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00996736     History of Changes
Other Study ID Numbers: H9332-33965-02, U10-EY018573-01A1
Study First Received: October 14, 2009
Results First Received: July 26, 2013
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration