The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo

Completed · Phase 3 · Has a placebo group

Conditions studied: Corneal Ulcer, Eye Infections, Fungal

In brief

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.

Key facts

Study ID

NCT00997035

Run by

University of California, San Francisco

People needed

240

Starts

2010-05-01

Expected to finish

2016-03-01

Last updated by the study team

2019-02-26

Who can join

Age: 16 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Proctor Foundation, UCSF — San Francisco, California, United States
• Aravind Eye Hospital — Coimbatore, Tamil Nadu, India
• Aravind Eye Hospitals — Madurai, Tamil Nadu, India
• Aravind Eye Hospital — Pondicherry, Tamil Nadu, India
• Aravind Eye Hospital — Tirunelveli, Tamil Nadu, India
• Bharatpur Eye Hospital — Bharatpur, Chitwan, Nepal
• Lumbini Eye Institute — Siddharthanagar, Lumbini, Nepal

Full record on ClinicalTrials.gov

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