drugset / Trial / NCT03230058

Combination Treatment of 5% Natamycin and 1% Voriconazole in Fungal Keratitis

NCT03230058 ↗

Phase 2/3 Unknown 55 enrolled L.V. Prasad Eye Institute
RandomizedParallel-groupQuadruple-blindTreatment

Summary

OBJECTIVE To evaluate the efficacy and safety of the concurrent treatment of 5% Natamycin and 1% Voriconazole in patients affected by fungal keratitis METHODS AND MATERIALS STUDY POPULATION Patients with smear and or culture proven fungal keratitis presenting to our Instituts, were eligible for enrollment. STUDY DESIGN Prospective double masked randomized clinical trial.

Timeline

Start
2017-01-01
Primary completion
2018-03-01
Completion
2018-09-30

Outcome

Missed primary endpoint

paper complete healing occurred in 38 of 48 eyes (79.2%) in the combination group and 35 of 46 eyes (76.1%) in the monotherapy group (absolute difference, 3.1%; 95% CI -13.2% to 19.4%; p=0.70). PMID 41365527 ↗

paper Adjunctive topical voriconazole did not significantly improve clinical outcomes compared with natamycin monotherapy. PMID 41365527 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Voriconazole Small molecule 1 % Topical
Background Natamycin Small molecule 5 % Topical