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Therapeutic Exploratory Study of Comparing Natamycin and Voriconazole to Treat Fungal Corneal Ulcer (MUTT_TE)

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ClinicalTrials.gov Identifier: NCT00557362
Recruitment Status : Completed
First Posted : November 14, 2007
Results First Posted : December 19, 2013
Last Update Posted : December 19, 2013
Sponsor:
Collaborators:
That Man May See, Inc.
Aravind Eye Hospitals, India
Dartmouth-Hitchcock Medical Center
Information provided by (Responsible Party):
University of California, San Francisco

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Fungal Keratitis
Interventions: Drug: Natamycin 5%
Drug: Voriconazole
Procedure: Corneal de-epithelialization

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From November 27, 2007 to May 12, 2008, all patients with a corneal ulcer presenting to Aravind Eye Hospital’s cornea clinics in Madurai and Pondicherry, India, were evaluated for eligibility. The Aravind Eye Care System is both a primary and tertiary care eye hospital in South India with a well-established cornea subspecialty clinic.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All patients with a corneal ulcer had corneal scrapings using a Kimura spatula for Gram stain and potassium hydroxide wet mount and had cultures plated on blood, chocolate, and potato dextrose agar. If all inclusion criteria and no exclusion criteria were met, the patient was enrolled in the study.

Reporting Groups
  Description
Topical Natamycin With Corneal De-epithelialization

Topical natamycin with corneal de-epithelialization.

Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.

Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.

Topical Natamycin Without Corneal De-epithelialization

Topical natamycin without corneal de-epithelialization.

Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.

Topical Voriconazole With Corneal De-epithelialization

Topical voriconazole with corneal de-epithelialization.

Drug: Voriconazole Voriconazole prepared as a 1% solution.

One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.

Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.

Topical Voriconazole Without Corneal De-epithelialization

Topical voriconazole without corneal de-epithelialization.

Drug: Voriconazole Voriconazole prepared as a 1% solution.

One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.


Participant Flow:   Overall Study
    Topical Natamycin With Corneal De-epithelialization   Topical Natamycin Without Corneal De-epithelialization   Topical Voriconazole With Corneal De-epithelialization   Topical Voriconazole Without Corneal De-epithelialization
STARTED   30   30   30   30 
COMPLETED   28   28   26   27 
NOT COMPLETED   2   2   4   3 



  Baseline Characteristics

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 Voriconazole With Corneal De-epithelialization

Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake

Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.

Topical Voriconazole Without Corneal De-epithelialization Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Topical Natamycin With Corneal De-epithelialization

Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.

Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications.

Topical Natamycin Without Corneal De-epithelialization Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
Total Total of all reporting groups

Baseline Measures
   Topical Voriconazole With Corneal De-epithelialization   Topical Voriconazole Without Corneal De-epithelialization   Topical Natamycin With Corneal De-epithelialization   Topical Natamycin Without Corneal De-epithelialization   Total 
Overall Participants Analyzed 
[Units: Participants]
 30   30   30   30   120 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.0  (14.5)   45.0  (14.5)   49.8  (11.9)   45.9  (13.1)   46.93  (13.72) 
Gender 
[Units: Participants]
         
Female   14   9   7   11   41 
Male   16   21   23   19   79 
Region of Enrollment 
[Units: Participants]
         
India   30   30   30   30   120 
Enrollment logMAR BSCVA [1] 
[Units: logMAR]
Mean (Standard Deviation)
 0.94  (0.66)   0.96  (0.66)   0.87  (0.67)   0.94  (0.61)   0.93  (0.64) 
[1] Best spectacle-corrected visual acuity at time of enrollment measured in logMAR


  Outcome Measures

1.  Primary:   Best Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model   [ Time Frame: 3 months from enrollment ]

2.  Secondary:   Time to Resolution of Epithelial Defect   [ Time Frame: 3 months from enrollment ]

3.  Secondary:   Size of Infiltrate/Scar Post-treatment Was Analyzed in a Linear Regression Model Using Enrollment Infiltrate/Scar Size as a Covariate.   [ Time Frame: 3 months from enrollment ]

4.  Secondary:   Subgroup Analysis - Best Spectacle-corrected Visual Acuity Examined by Voriconazole and Natamycin Treatment Arms in Subgroups of Fungal Ulcers (Fusarium Spp and Aspergillus Spp).   [ Time Frame: 3 months from enrollment ]

5.  Secondary:   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   [ Time Frame: 3 months from enrollment ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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: Tom M/ Lietman
Organization: University of California San Francisco Proctor Foundation
phone: 4155022662
e-mail: tom.lietman@ucsf.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00557362     History of Changes
Other Study ID Numbers: H9332-31301-01
First Submitted: November 9, 2007
First Posted: November 14, 2007
Results First Submitted: June 14, 2013
Results First Posted: December 19, 2013
Last Update Posted: December 19, 2013