Mycotic Ulcer Treatment Trial I

Mycotic Ulcer Treatment Trial

Sponsors

Lead Sponsor: University of California, San Francisco

Collaborator: Aravind Eye Hospitals, India
Dartmouth-Hitchcock Medical Center
National Eye Institute (NEI)

Source University of California, San Francisco
Brief Summary

The purpose of this study is to determine if natamycin or voriconazole results in better visual outcomes in fungal corneal ulcers, especially visual acuity.

Detailed Description

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 natamycin or voriconazole results in better outcomes for fungal corneal ulcers. 368 fungal corneal ulcers with baseline visual acuity between 6/12 (20/40, logMAR 0.3) and 6/120 (20/400, logMAR 1.3) presenting to the Aravind Eye Hospitals and the UCSF Proctor Foundation will be randomized to receive either topical natamycin or topical voriconazole. The primary outcome is best spectacle-corrected logMAR visual acuity three months after enrollment, using best spectacle-corrected enrollment visual acuity as a co-variate.

Overall Status Completed
Start Date 2010-04-01
Completion Date 2012-07-01
Primary Completion Date 2012-07-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Best Spectacle-corrected logMAR Visual Acuity 3 months from enrollment
Secondary Outcome
Measure Time Frame
Best Spectacle-corrected logMAR Visual Acuity 3 weeks after enrollment
Hard Contact Lens-corrected Visual Acuity Measured in logMAR 3 months after enrollment
Size of Infiltrate/Scar 3 weeks and 3 months after enrollment
Time to Resolution of Epithelial Defect From enrollment to the time of resolution of epithelial defect
Minimum Inhibitory Concentration of Isolates 3 months after enrollment
Microbiological Cure at 6 Days 7 days after enrollment
Enrollment 323
Condition
Intervention

Intervention Type: Drug

Intervention Name: Natamycin

Description: 5% natamycin plus 0.02% preservative, one drop to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until 3 weeks after enrollment.

Arm Group Label: Topical Natamycin

Intervention Type: Drug

Intervention Name: Voriconazole

Description: 1% voriconazole plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.

Arm Group Label: Topical Voriconazole

Eligibility

Criteria:

Inclusion Criteria: - Presence of a corneal ulcer at presentation - Evidence of filamentous fungus on smear (KOH wet mount, Giemsa, or Gram stain) - Visual acuity between 6/12 (20/40, logMAR 0.3) and 6/120 (20/400, logMAR 1.3) - The patient must be able to verbalize a basic understanding of the study after it is explained to the patient, as determined by physician examiner. This understanding must include a commitment to return for follow-up visits. - Willingness to be treated as an inpatient or to be treated as an outpatient and return every 3 days +/- 1 day until re-epithelialization and every week to receive fresh medication for 3 weeks - Appropriate consent Exclusion Criteria: - Impending perforation - Evidence of bacteria on Gram stain at the time of enrollment - Evidence of acanthamoeba by stain - Evidence of herpetic keratitis by history or exam - Corneal scar not easily distinguishable from current ulcer - Age less than 16 years (before 16th birthday) - Bilateral ulcers - Previous penetrating keratoplasty in the affected eye - Pregnancy (by history or urine test) or breast feeding (by history) - Acuity worse than 6/60 (2/200) in the fellow eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA 6/60 or better qualifies for enrollment) - Acuity worse than 6/120 (20/400) or better than 6/12 (20/40) in the study eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA can be used for enrollment) - Known allergy to study medications (antifungal or preservative) - No light perception in the affected eye - Not willing to participate

Gender:

All

Minimum Age:

16 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Location
Facility:
Proctor Foundation, UCSF | San Francisco, California, 94143, United States
Aravind Eye Hospitals | Madurai, Tamil Nadu, India
Aravind Eye Hospital | Pondicherry, Tamil Nadu, India
Location Countries

India

United States

Verification Date

2018-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of California, San Francisco

Investigator Full Name: Thomas M. Lietman

Investigator Title: Professor in Residence

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Topical Natamycin

Type: Active Comparator

Label: Topical Voriconazole

Type: Experimental

Acronym MUTT I
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

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