Phase 3
N=323
Mycotic Ulcer Treatment Trial I
Corneal Ulcer · Eye Infections, Fungal
Bottom Line
View on ClinicalTrials.gov: NCT00996736 ↗Enrolled (actual)
323
Serious AEs
38.4%
Results posted
Dec 2013
Primary outcome: Primary: Best Spectacle-corrected logMAR Visual Acuity — 0.39; 0.57 logMAR — p=0.006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Natamycin (Drug); Voriconazole (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Spectacle-corrected logMAR Visual Acuity |
0.49; 0.63 | — |
| SECONDARY Best Spectacle-corrected logMAR Visual Acuity |
0.49; 0.63 | — |
| SECONDARY Hard Contact Lens-corrected Visual Acuity Measured in logMAR |
0.18; 0.30 | — |
| SECONDARY Size of Infiltrate/Scar |
3.30; 3.44; 3.31; 3.52 | — |
| SECONDARY Time to Resolution of Epithelial Defect |
11.50; 11.50 | — |
| SECONDARY Minimum Inhibitory Concentration of Isolates |
4; 2 | — |
| SECONDARY Microbiological Cure at 6 Days |
23; 69 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT00996736). 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.