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

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.

Conditions

• Corneal Ulcer
• Eye Infections, Fungal

Interventions

DRUG

Voriconazole

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.

DRUG

Placebo

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.

Sponsors & Collaborators

• Aravind Eye Hospitals, India

  collaborator OTHER

• Dartmouth-Hitchcock Medical Center

  collaborator OTHER

• Lumbini Eye Institute and Research Centre

  collaborator OTHER

• Bharatpur Eye Hospital

  collaborator OTHER

• National Eye Institute (NEI)

  collaborator NIH

• University of California, San Francisco

  lead OTHER

Principal Investigators

• NV Prajna, DNB, FRC Ophth · Aravind Eye Hospitals

• Nisha Acharya, MD, MS · Proctor Foundation, UCSF

• Tom Lietman, MD · Proctor Foundation, UCSF

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-05-31

Primary Completion

2016-01-31

Completion

2016-03-31

Countries

• United States
• India
• Nepal

Study Locations