Mycotic Ulcer Treatment Trial I

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Aravind Eye Hospitals, India; Dartmouth-Hitchcock Medical Center; National Eye Institute (NEI)
• Treatments: Natamycin; 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 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