Phase 3
N=240
The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo
Corneal Ulcer · Eye Infections, Fungal
Bottom Line
View on ClinicalTrials.gov: NCT00997035 ↗Enrolled (actual)
240
Serious AEs
3.3%
Results posted
Jun 2017
Primary outcome: Primary: Incidence of Perforation or Therapeutic Penetrating Keratoplasty — 0.0095562; 0.011204 New perforations or TPK/person-days — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Voriconazole (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Perforation or Therapeutic Penetrating Keratoplasty |
0.0095562; 0.011204 | 0.29 |
| SECONDARY Best Spectacle-corrected logMAR Visual Acuity |
.7852594; .787141 | — |
| SECONDARY Best Spectacle-corrected logMAR Visual Acuity at 3-weeks |
.8745454; .744252 | — |
| SECONDARY Size of Infiltrate/Scar - 3 Months |
.9319315; .697005 | — |
| SECONDARY Size of Infiltrate/Scar |
.2192398; .7973467 | — |
| SECONDARY Hazard Ratio for Re-epithelialization |
.0141123; .0130862 | 0.65 |
| SECONDARY Microbiological Cure at 7 Days |
50; 50 | — |
| SECONDARY Number of Adverse Events |
58; 28 | <0.001 sig |
| SECONDARY Minimum Inhibitory Concentration of Isolates - Natamycin |
12; 4 | — |
| SECONDARY Minimum Inhibitory Concentration of Isolates - Voriconazole |
1; 2 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00997035). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.