CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 240 enrolled
Drug / intervention
Voriconazole +1 moredrug
Likely dose
Voriconazole 400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00997035
NCT00997035Phase 3Completed
CompareCT.gov

The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole vs Placebo

University of California, San Francisco·interventional·Posted Oct 16, 2009·Updated Feb 26, 2019

In Brief

A Phase 3 clinical trial evaluating Voriconazole and Placebo for Corneal Ulcer and Eye Infections, Fungal. Completed, enrolled 240 participants across 7 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCorneal Ulcer, Eye Infections, Fungal
CountriesIndia, Nepal, United States
CollaboratorsAravind Eye Hospitals, India, Dartmouth-Hitchcock Medical Center, Lumbini Eye Institute and Research Centre, Bharatpur Eye Hospital, National Eye Institute (NEI)

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 16, 2009
Enrollment StartMay 1, 2010
Primary CompletionJan 1, 2016
Study CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 16.7 years ago

Interventions

Voriconazoledrug

1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment. 5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment. 400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing \<40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment.

Placebodrug

1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment. 5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment. Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment.