Phase 2
N=120
Therapeutic Exploratory Study of Comparing Natamycin and Voriconazole to Treat Fungal Corneal Ulcer
Fungal Keratitis
Bottom Line
View on ClinicalTrials.gov: NCT00557362 ↗Enrolled (actual)
120
Serious AEs
16.7%
Results posted
Dec 2013
Primary outcome: Primary: Best Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model — 0.61; 0.71 logMAR — p=0.29
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Natamycin 5% (Drug); Voriconazole (Drug); Corneal de-epithelialization (Procedure)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best Spectacle Corrected Visual Acuity (BSCVA) 3 Months After Enrollment, Adjusting for Enrollment BSCVA in a Multiple Linear Regression Model |
0.61; 0.71 | 0.29 |
| SECONDARY Time to Resolution of Epithelial Defect |
13.07; 15.2 | 0.40 |
| SECONDARY Size of Infiltrate/Scar Post-treatment Was Analyzed in a Linear Regression Model Using Enrollment Infiltrate/Scar Size as a Covariate. |
4.21; 4.08 | 0.37 |
| SECONDARY Subgroup Analysis - Best Spectacle-corrected Visual Acuity Examined by Voriconazole and Natamycin Treatment Arms in Subgroups of Fungal Ulcers (Fusarium Spp and Aspergillus Spp). |
0.58; 0.50; 0.48; 0.68 | 0.62 |
| SECONDARY Best Hard Contact Lens-corrected Visual Acuity 3 Months After Enrollment in a Multiple Linear Regression Model With Enrollment Hard Contact Lens-corrected Visual Acuity as a Covariate |
0.39; 0.46 | 0.53 |
Summary
We evaluated whether voriconazole is a superior treatment to natamycin for filamentous fungal keratitis in a randomized, masked, controlled trial. This is a therapeutic exploratory study to investigate the safety and feasibility of conducting a larger study and to generate preliminary data.
Eligibility Criteria
Inclusion Criteria
- Presence of a corneal ulcer at presentation
- Evidence of filamentous fungus on KOH (or Giemsa or any other stain) or culture
- 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 in-patient or to be treated as an out-patient and come back every 48-72 hours to receive fresh medication for 3 weeks
- Appropriate consent
Exclusion Criteria
- Overlying epithelial defect < 0.5 mm at its greatest width at presentation
- 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 (20/200) in the fellow eye (note that any acuity, uncorrected, corrected, pinhole, or BSCVA 6/60 or better qualifies 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 (NCT00557362). 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.