Phase 3
N=70
Mycotic Antimicrobial Localized Injection for Treatment of Corneal Ulcers
Corneal Ulcer · Fungal Keratitis
Bottom Line
View on ClinicalTrials.gov: NCT02731638 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus — 14; 11 Participants — p=0.26
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Intrastromal voriconazole (Drug); Natamycin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Culture Positivity at Day 3 Using Potassium Hydroxide (KOH) Wet Mount to Test for Fungus |
14; 11 | 0.26 |
| SECONDARY Best Spectacle-corrected Visual Acuity, as Measured by a Refractionist |
1.39; 1.23; 1.30; 1.28 | 0.25 |
| SECONDARY Scar Size |
4.8; 4.1; 4.9; 4.5 | — |
| SECONDARY Number of Participants With Scar Depth at the Anterior Third, Middle Third, and Posterior Third of the Cornea |
9; 13; 8; 2; 7; 1 | — |
Summary
Mycotic Antimicrobial Localized Injection (MALIN) is a randomized, masked, two-arm clinical trial investigating intrastromal voriconazole in the treatment of fungal corneal ulcers. There is currently little evidence to guide the treatment of fungal keratitis beyond topical anti-fungal drops, though intrastromal voriconazole and oral antifungal treatments are used as well. This study will provide evidence to guide the treatment of fungal keratitis in the future. The purpose of this study is to determine differences in microbiological cure for 3-day repeat cultures between different antifungal treatments. For this study, there will be 1:1 randomization to one of these two treatment groups: 1) topical natamycin plus intrastromal voriconazole injection or 2) topical natamycin alone.
Eligibility Criteria
Inclusion Criteria
- Moderate to severe corneal ulcer that is smear positive for filamentous fungus
- Pinhole visual acuity worse than 20/70 in affected eye
- Basic understanding of the study as determined by the physician
- Commitment to return for follow up visits
Exclusion Criteria
- Gram stain positive for bacteria or evidence of other concomitant infection (i.e. herpes, acanthamoeba)
- Impending or frank perforation at recruitment
- Involvement of sclera at presentation
- Non-infectious or autoimmune keratitis
- History of corneal transplantation or recent intraocular surgery
- No light perception in the affected eye
- Pinhole visual acuity worse than 20/200 in the unaffected eye
- Pregnant women
- Participants who are decisionally and/or cognitively impaired
Data sourced from ClinicalTrials.gov (NCT02731638). 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.