Status:
COMPLETED
The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
Aravind Eye Hospitals, India
Dartmouth-Hitchcock Medical Center
Conditions:
Corneal Ulcer
Eye Infections, Fungal
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if the addition of oral voriconazole to topical treatment regimens results in lower rates of perforation in severe fungal corneal ulcers.
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-...
Eligibility Criteria
Inclusion
- Presence of a corneal ulcer at presentation
- Evidence of filamentous fungus on smear (KOH wet mount, Giemsa, or Gram stain)
- Visual acuity worse than 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
- 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)
- Known liver disease, including hepatitis or cirrhosis (Child-Pugh A-C)
- 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 better than 6/120 (20/400) in the study eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA can be used for enrollment)
- Currently on rifampin, rifabutin, ritonavir, long acting barbiturates, phenytoin, carbamazepine, or other drugs known to interact with voriconazole
- Known allergy to study medications (antifungal or preservative)
- No light perception in the affected eye
- Not willing to participate
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00997035
Start Date
May 1 2010
End Date
March 1 2016
Last Update
February 26 2019
Active Locations (7)
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1
Proctor Foundation, UCSF
San Francisco, California, United States, 94143
2
Aravind Eye Hospital
Coimbatore, Tamil Nadu, India
3
Aravind Eye Hospitals
Madurai, Tamil Nadu, India
4
Aravind Eye Hospital
Pondicherry, Tamil Nadu, India