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

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Aravind Eye Hospitals, India; Bharatpur Eye Hospital; Bharatpur Eye Hospital, Nepal; Dartmouth-Hitchcock Medical Center; Lumbini Eye Institute and Hospital; National Eye Institute (NEI)
• Treatments: Voriconazole

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 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 Criteria:

• 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